Childhood Obesity Treatment Designed for Low Income and Hispanic Families

Physical Activity Clinical Trial

Official title:

Family Inclusive Childhood Obesity Treatment Designed for Low Income and Hispanic Families

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05041855
• Other study ID #: 21-3721
• Secondary ID: 1R01DK130176-01
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: May 31, 2027

Study information

• Verified date: June 2023
• Source: University of Colorado, Denver
• Contact: Matthew A Haemer, MD MPH
• Phone: 7207772691
• Email: matthew.haemer[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a type-1 hybrid effectiveness-implementation RCT comparing a novel family-inclusive childhood obesity treatment program, the "Healthy Living Program" (HeLP), to a protocol that enhances usual primary care to deliver Recommended Treatment of Obesity in Primary Care (RTOP). Children with obesity and their families will be referred to the study by primary care providers and randomized to HeLP or RTOP. The clinical setting is a practice-based research network serving majority Hispanic and Medicaid-insured populations. The intensive phase and booster sessions of HeLP will take place at recreation centers located near the clinics and will be led by health educators employed by the clinics. Visits with primary care providers (PCPs) for HeLP maintenance or RTOP will occur at the clinics.

Description:

This study is a Randomized Controlled Trial (RCT) to learn about how well a family childhood weight management program works compared to healthy lifestyle counseling by providers at participating clinics. The goal is to compare weight change in children with obesity from low-income predominantly Hispanic/Latino families that will participate in the program, the Healthy Living Program (HeLP) vs. Recommended Treatment of Obesity in Primary Care (RTOP). Low-income children with obesity from mostly Hispanic clinical populations will be referred to the project by their primary doctors and will be enrolled into either HeLP or RTOP. Families (including siblings and caregivers) who are in HeLP will be offered 12 sessions at local rec centers where health educators and fitness trainers will teach them about parenting skills, nutrition, fitness, and mindfulness. Families who are in RTOP will receive an enhanced version of the care that is usually provided at their primary care clinics. Providers will be trained in a skill called Motivational Interviewing and use an electronic tool called "HeartSmartKids" to help families make healthy lifestyle changes. Families who are in RTOP will go to follow-up visits every 3 months and will go to HeLP after 18 months. Aim 1 (Treatment): To compare the BMI change relative to the 95th percentile for age and sex in children with obesity in 3 different age groups (2-6, 7-12, and 13-16 years old) 18 months after being in either HeLP or RTOP. Aim 2 (Prevention): To compare the weight change in healthy and unhealthy weight 2-6-year-old children who have siblings with obesity and are in either HeLP or RTOP. Aim 3 (Implementation): To describe implementation processes of HeLP and RTOP using a framework called RE-AIM: R-Reach: Is the project reaching the people it needs to reach? E-Effectiveness: Is the program effective? A-Adoption: are the health educators, providers, and clinics promoting and doing the program? I-Implementation: Are the health educators, providers and clinics delivering the intervention as intended? M-Maintenance: Is the intervention working to help children with their weight and healthy lifestyle changes? The cost of delivering the program will also be studied to inform potential sustainability.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 658
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Child aged 2-16yrs
• With overweight or obesity (BMI >85th percentile)
• Referred by PCP
• Primary Adult Caregiver
• Up to two siblings of any BMI status (if multiple siblings are available, enrollment goals stratified by age and BMI will be used to select siblings for enrollment.)

Exclusion Criteria:

• Parent without fluency in either Spanish or English
• Current participation in a clinically referred obesity treatment program
• Child non-ambulatory, non-verbal, or diagnosed with a genetic syndrome associated with obesity.
• Children with severe depression on initial screening (CES-D >/=40 or suicidal ideation) will be excluded and referred to psychiatric treatment and therapy.
• Children who have been diagnosed by PCP at time of initial screening with severe

comorbidities of obesity, including:

• Type 2 diabetes
• Stage 2 hypertension
• Severe hyperlipidemia
• Severe obstructive sleep apnea will be excluded from the study and directed to the only Tertiary Care Childhood Obesity Treatment program in the state of Colorado: Lifestyle Medicine at Children's Hospital Colorado.

Related Conditions & MeSH terms

• Counseling
• Family
• Healthy Eating
• Mindfulness
• Minority Health
• Obesity
• Pediatric Obesity
• Physical Activity

Intervention

Behavioral:
• The Healthy Living Program/La Vida Saludable
A whole-family group childhood obesity intervention delivered at community recreation centers
• Recommended Treatment of Obesity in Primary Care
A healthy lifestyle counseling protocol that enhances usual primary care

Locations

Country	Name	City	State
United States	University of Colorado Anschutz	Aurora	Colorado
United States	Colorado State University-College of Health and Human Sciences	Fort Collins	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Colorado State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (88)

Aguayo-Mazzucato C, Diaque P, Hernandez S, Rosas S, Kostic A, Caballero AE. Understanding the growing epidemic of type 2 diabetes in the Hispanic population living in the United States. Diabetes Metab Res Rev. 2019 Feb;35(2):e3097. doi: 10.1002/dmrr.3097. Epub 2018 Dec 4. — View Citation

Arora S, Kalishman SG, Thornton KA, Komaromy MS, Katzman JG, Struminger BB, Rayburn WF, Bradford AM. Project ECHO: A Telementoring Network Model for Continuing Professional Development. J Contin Educ Health Prof. 2017 Fall;37(4):239-244. doi: 10.1097/CEH.0000000000000172. Erratum In: J Contin Educ Health Prof. 2018 Winter;38(1):78. — View Citation

Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C. — View Citation

Belay B, Frintner MP, Liebhart JL, Lindros J, Harrison M, Sisk B, Dooyema CA, Hassink SG, Cook SR. US Pediatrician Practices and Attitudes Concerning Childhood Obesity: 2006 and 2017. J Pediatr. 2019 Aug;211:78-84.e2. doi: 10.1016/j.jpeds.2019.04.030. Epub 2019 May 18. — View Citation

Bleich SN, Segal J, Wu Y, Wilson R, Wang Y. Systematic review of community-based childhood obesity prevention studies. Pediatrics. 2013 Jul;132(1):e201-10. doi: 10.1542/peds.2013-0886. Epub 2013 Jun 10. — View Citation

Blumberg SJ, Bialostosky K, Hamilton WL, Briefel RR. The effectiveness of a short form of the Household Food Security Scale. Am J Public Health. 1999 Aug;89(8):1231-4. doi: 10.2105/ajph.89.8.1231. — View Citation

Butte NF, Hoelscher DM, Barlow SE, Pont S, Durand C, Vandewater EA, Liu Y, Adolph AL, Perez A, Wilson TA, Gonzalez A, Puyau MR, Sharma SV, Byrd-Williams C, Oluyomi A, Huang T, Finkelstein EA, Sacher PM, Kelder SH. Efficacy of a Community- Versus Primary Care-Centered Program for Childhood Obesity: TX CORD RCT. Obesity (Silver Spring). 2017 Sep;25(9):1584-1593. doi: 10.1002/oby.21929. Epub 2017 Jul 13. — View Citation

Cappelleri JC, Bushmakin AG, Gerber RA, Leidy NK, Sexton CC, Lowe MR, Karlsson J. Psychometric analysis of the Three-Factor Eating Questionnaire-R21: results from a large diverse sample of obese and non-obese participants. Int J Obes (Lond). 2009 Jun;33(6):611-20. doi: 10.1038/ijo.2009.74. Epub 2009 Apr 28. — View Citation

Cardel MI, Tong S, Pavela G, Dhurandhar E, Miller D, Boles R, Haemer M. Youth Subjective Social Status (SSS) is Associated with Parent SSS, Income, and Food Insecurity but not Weight Loss Among Low-Income Hispanic Youth. Obesity (Silver Spring). 2018 Dec;26(12):1923-1930. doi: 10.1002/oby.22314. Epub 2018 Nov 13. — View Citation

Cason-Wilkerson R, Goldberg S, Albright K, Allison M, Haemer M. Factors influencing healthy lifestyle changes: a qualitative look at low-income families engaged in treatment for overweight children. Child Obes. 2015 Apr;11(2):170-6. doi: 10.1089/chi.2014.0147. Epub 2015 Feb 25. — View Citation

Chambers DA. Sharpening our focus on designing for dissemination: Lessons from the SPRINT program and potential next steps for the field. Transl Behav Med. 2020 Dec 31;10(6):1416-1418. doi: 10.1093/tbm/ibz102. — View Citation

Cidav Z, Mandell D, Pyne J, Beidas R, Curran G, Marcus S. A pragmatic method for costing implementation strategies using time-driven activity-based costing. Implement Sci. 2020 May 5;15(1):28. doi: 10.1186/s13012-020-00993-1. — View Citation

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. — View Citation

Dabelea D, Mayer-Davis EJ, Saydah S, Imperatore G, Linder B, Divers J, Bell R, Badaru A, Talton JW, Crume T, Liese AD, Merchant AT, Lawrence JM, Reynolds K, Dolan L, Liu LL, Hamman RF; SEARCH for Diabetes in Youth Study. Prevalence of type 1 and type 2 diabetes among children and adolescents from 2001 to 2009. JAMA. 2014 May 7;311(17):1778-86. doi: 10.1001/jama.2014.3201. — View Citation

Davidson AJ, McCormick EV, Dickinson LM, Haemer MA, Knierim SD, Hambidge SJ. Population-level obesity surveillance: monitoring childhood body mass index z-score in a safety-net system. Acad Pediatr. 2014 Nov-Dec;14(6):632-8. doi: 10.1016/j.acap.2014.06.007. Epub 2014 Oct 30. — View Citation

Fagg J, Chadwick P, Cole TJ, Cummins S, Goldstein H, Lewis H, Morris S, Radley D, Sacher P, Law C. From trial to population: a study of a family-based community intervention for childhood overweight implemented at scale. Int J Obes (Lond). 2014 Oct;38(10):1343-9. doi: 10.1038/ijo.2014.103. Epub 2014 Jun 12. — View Citation

Faulstich ME, Carey MP, Ruggiero L, Enyart P, Gresham F. Assessment of depression in childhood and adolescence: an evaluation of the Center for Epidemiological Studies Depression Scale for Children (CES-DC). Am J Psychiatry. 1986 Aug;143(8):1024-7. doi: 10.1176/ajp.143.8.1024. — View Citation

Finkelstein EA, Khavjou OA, Thompson H, Trogdon JG, Pan L, Sherry B, Dietz W. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012 Jun;42(6):563-70. doi: 10.1016/j.amepre.2011.10.026. — View Citation

Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187. — View Citation

Freedman DS, Berenson GS. Tracking of BMI z Scores for Severe Obesity. Pediatrics. 2017 Sep;140(3):e20171072. doi: 10.1542/peds.2017-1072. Epub 2017 Aug 22. — View Citation

Freedman DS, Butte NF, Taveras EM, Goodman AB, Blanck HM. Longitudinal changes in BMI z-scores among 45 414 2-4-year olds with severe obesity. Ann Hum Biol. 2017 Dec;44(8):687-692. doi: 10.1080/03014460.2017.1388845. Epub 2017 Oct 30. — View Citation

Freedman DS, Butte NF, Taveras EM, Goodman AB, Ogden CL, Blanck HM. The Limitations of Transforming Very High Body Mass Indexes into z-Scores among 8.7 Million 2- to 4-Year-Old Children. J Pediatr. 2017 Sep;188:50-56.e1. doi: 10.1016/j.jpeds.2017.03.039. Epub 2017 Apr 19. — View Citation

Freedman DS, Butte NF, Taveras EM, Lundeen EA, Blanck HM, Goodman AB, Ogden CL. BMI z-Scores are a poor indicator of adiposity among 2- to 19-year-olds with very high BMIs, NHANES 1999-2000 to 2013-2014. Obesity (Silver Spring). 2017 Apr;25(4):739-746. doi: 10.1002/oby.21782. Epub 2017 Feb 28. — View Citation

Garrison CZ, Addy CL, Jackson KL, McKeown RE, Waller JL. The CES-D as a screen for depression and other psychiatric disorders in adolescents. J Am Acad Child Adolesc Psychiatry. 1991 Jul;30(4):636-41. doi: 10.1097/00004583-199107000-00017. — View Citation

Gattshall ML, Shoup JA, Marshall JA, Crane LA, Estabrooks PA. Validation of a survey instrument to assess home environments for physical activity and healthy eating in overweight children. Int J Behav Nutr Phys Act. 2008 Jan 11;5:3. doi: 10.1186/1479-5868-5-3. — View Citation

Gauthier KI, Gance-Cleveland B. Hispanic parents' perceptions of their preschool children's weight status. J Spec Pediatr Nurs. 2016 Apr;21(2):84-93. doi: 10.1111/jspn.12143. Epub 2016 Apr 15. — View Citation

Gilbert, K., et al., Using Health IT to bridge clinic and community in the fight against childhood obesity, in American Public Health Association. 2012: San Francisco. p. publication #268558.

Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019. — View Citation

Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322. — View Citation

Haemer MA, Ranade D, Baron AE, Krebs NF. A clinical model of obesity treatment is more effective in preschoolers and Spanish speaking families. Obesity (Silver Spring). 2013 May;21(5):1004-12. doi: 10.1002/oby.20192. — View Citation

Haemer, M., et al. An Enhanced Screen Performs Better than 5-2-1-0 for Lifestyle Assessment in Low-Income Hispanic Children. in Pediatric Academic Societies. 2012. Boston, MA

Haemer, M., et al. Controlled Trial of Technology Supported Motivational Interviewing for Childhood Obesity. in The Obesity Society. 2013. Atlanta, GA.

Haemer, M., et al. One-Year Outcomes from a Controlled Trial of Family-Inclusive Weight Management in Underserved Children. in Pediatric Academic Societies. 2015. San Diego, CA

Haemer, M., et al., Beyond 5210: Results of Universal Lifestyle Screening in Community Health Centers, in Pediatric Academic Societies. 2016: Baltimore, MD.

Haemer, M., et al., Food Neophobia in Latino Preschoolers: Correlation with Intake and Pilot Intervention Results, in American Society of Nutrition Annual Meeting at Experimental Biology. 2014: San Diego, CA

Haemer, M., et al., Mixed Methods Study of Motivational Interviewing Training on Providers' Counseling for Healthy Weight, in Pediatric Academic Societies. 2018: Toronto, Ontario.

Haemer, M., et al., Pilot Results of a Multi-level Partnership to treat Obesity in Low-Income Hispanic Children, in The Obesity Society Annual Meeting. 2011. p. publication # LB-P-50

Haemer, M., Why Does Cooking Matter? Outcomes of Nutrition Education in Collaboration with Health Care, in Share Our Strength's National Convening. 2015: Washington DC.

Hasan B, Thompson WG, Almasri J, Wang Z, Lakis S, Prokop LJ, Hensrud DD, Frie KS, Wirtz MJ, Murad AL, Ewoldt JS, Murad MH. The effect of culinary interventions (cooking classes) on dietary intake and behavioral change: a systematic review and evidence map. BMC Nutr. 2019 May 10;5:29. doi: 10.1186/s40795-019-0293-8. eCollection 2019. — View Citation

Hernandez RG, Cheng TL, Serwint JR. Parents' healthy weight perceptions and preferences regarding obesity counseling in preschoolers: pediatricians matter. Clin Pediatr (Phila). 2010 Aug;49(8):790-8. doi: 10.1177/0009922810368288. Epub 2010 Jun 3. — View Citation

Hoelscher DM, Butte NF, Barlow S, Vandewater EA, Sharma SV, Huang T, Finkelstein E, Pont S, Sacher P, Byrd-Williams C, Oluyomi AO, Durand C, Li L, Kelder SH. Incorporating primary and secondary prevention approaches to address childhood obesity prevention and treatment in a low-income, ethnically diverse population: study design and demographic data from the Texas Childhood Obesity Research Demonstration (TX CORD) study. Child Obes. 2015 Feb;11(1):71-91. doi: 10.1089/chi.2014.0084. Epub 2015 Jan 2. — View Citation

Hollingworth W, Hawkins J, Lawlor DA, Brown M, Marsh T, Kipping RR. Economic evaluation of lifestyle interventions to treat overweight or obesity in children. Int J Obes (Lond). 2012 Apr;36(4):559-66. doi: 10.1038/ijo.2011.272. Epub 2012 Jan 17. — View Citation

Kelly ML, Ackerman PD, Ross LF. The participation of minorities in published pediatric research. J Natl Med Assoc. 2005 Jun;97(6):777-83. — View Citation

Kirk S, Zeller M, Claytor R, Santangelo M, Khoury PR, Daniels SR. The relationship of health outcomes to improvement in BMI in children and adolescents. Obes Res. 2005 May;13(5):876-82. doi: 10.1038/oby.2005.101. — View Citation

Klein JD, Sesselberg TS, Johnson MS, O'Connor KG, Cook S, Coon M, Homer C, Krebs N, Washington R. Adoption of body mass index guidelines for screening and counseling in pediatric practice. Pediatrics. 2010 Feb;125(2):265-72. doi: 10.1542/peds.2008-2985. Epub 2010 Jan 18. — View Citation

Knierim SD, Newcomer S, Castillo A, Rahm AK, Raghunath S, Clarke C, Wright L, Haemer M, Hambidge SJ. Latino Parents' Perceptions of Pediatric Weight Counseling Terms. Acad Pediatr. 2018 Apr;18(3):342-353. doi: 10.1016/j.acap.2017.09.006. Epub 2017 Sep 12. — View Citation

Knierim SD, Rahm AK, Haemer M, Raghunath S, Martin C, Yang A, Clarke C, Hambidge SJ. Latino parents' perceptions of weight terminology used in pediatric weight counseling. Acad Pediatr. 2015 Mar-Apr;15(2):210-7. doi: 10.1016/j.acap.2014.11.003. Epub 2014 Dec 20. — View Citation

Knight GP, Gonzales NA, Saenz DS, Bonds DD, German M, Deardorff J, Roosa MW, Updegraff KA. The Mexican American Cultural Values scales for Adolescents and Adults. J Early Adolesc. 2010 Jun;30(3):444-481. doi: 10.1177/0272431609338178. — View Citation

Lee H, Hicken MT. Cumulative social risk and racial/ethnic disparities in obesity during the transition to adulthood. J Health Care Poor Underserved. 2013 May;24(2):907-27. doi: 10.1353/hpu.2013.0090. — View Citation

Li PP, Mackey G, Callender C, Dave JM, Olvera N, Alford S, Thompson D. Culinary Education Programs for Children in Low-Income Households: A Scoping Review. Children (Basel). 2020 May 13;7(5):47. doi: 10.3390/children7050047. — View Citation

Liu GC, Hannon T, Qi R, Downs SM, Marrero DG. The obesity epidemic in children: Latino children are disproportionately affected at younger ages. Int J Pediatr Adolesc Med. 2015 Mar;2(1):12-18. doi: 10.1016/j.ijpam.2015.03.004. Epub 2015 Apr 4. — View Citation

Love-Osborne K, Fortune R, Sheeder J, Federico S, Haemer MA. School-based health center-based treatment for obese adolescents: feasibility and body mass index effects. Child Obes. 2014 Oct;10(5):424-31. doi: 10.1089/chi.2013.0165. Epub 2014 Sep 26. — View Citation

Lozano P, McPhillips HA, Hartzler B, Robertson AS, Runkle C, Scholz KA, Stout JW, Kieckhefer GM. Randomized trial of teaching brief motivational interviewing to pediatric trainees to promote healthy behaviors in families. Arch Pediatr Adolesc Med. 2010 Jun;164(6):561-6. doi: 10.1001/archpediatrics.2010.86. — View Citation

Martin-Garcia M, Vila-Maldonado S, Rodriguez-Gomez I, Faya FM, Plaza-Carmona M, Pastor-Vicedo JC, Ara I. The Spanish version of the Three Factor Eating Questionnaire-R21 for children and adolescents (TFEQ-R21C): Psychometric analysis and relationships with body composition and fitness variables. Physiol Behav. 2016 Oct 15;165:350-7. doi: 10.1016/j.physbeh.2016.08.015. Epub 2016 Aug 15. — View Citation

Maskarinec G, Grandinetti A, Matsuura G, Sharma S, Mau M, Henderson BE, Kolonel LN. Diabetes prevalence and body mass index differ by ethnicity: the Multiethnic Cohort. Ethn Dis. 2009 Winter;19(1):49-55. — View Citation

Mauricio AM, Tein JY, Gonzales NA, Millsap RE, Dumka LE. Attendance Patterns and Links to Non-Response on Child Report of Internalizing among Mexican-Americans Randomized to a Universal Preventive Intervention. Prev Sci. 2018 Feb;19(Suppl 1):27-37. doi: 10.1007/s11121-016-0632-9. — View Citation

McGavock J, Chauhan BF, Rabbani R, Dias S, Klaprat N, Boissoneault S, Lys J, Wierzbowski AK, Sakib MN, Zarychanski R, Abou-Setta AM. Layperson-Led vs Professional-Led Behavioral Interventions for Weight Loss in Pediatric Obesity: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Jul 1;3(7):e2010364. doi: 10.1001/jamanetworkopen.2020.10364. — View Citation

Mills SD, Malcarne VL, Fox RS, Sadler GR. Psychometric Evaluation of the Brief Acculturation Scale for Hispanics. Hisp J Behav Sci. 2014 May 1;36(2):164-174. doi: 10.1177/0739986314526697. — View Citation

Moore, J., et al., Weight-Related Quality of Life in a Community-Based Weight Management Trial among Underserved Youth, in The Obesity Society. 2019: Las Vegas, NV.

Moyers TB, Rowell LN, Manuel JK, Ernst D, Houck JM. The Motivational Interviewing Treatment Integrity Code (MITI 4): Rationale, Preliminary Reliability and Validity. J Subst Abuse Treat. 2016 Jun;65:36-42. doi: 10.1016/j.jsat.2016.01.001. Epub 2016 Jan 13. — View Citation

Nederveld A, Cox-Martin M, Bayliss E, Allison M, Haemer M. Food Insecurity and Healthy Behavior Counseling in Primary Care. J Health Dispar Res Pract. 2018 Fall;11(3):49-58. — View Citation

O'Connor EA, Evans CV, Burda BU, Walsh ES, Eder M, Lozano P. Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2017 Jun 20;317(23):2427-2444. doi: 10.1001/jama.2017.0332. — View Citation

Overcash F, Ritter A, Mann T, Mykerezi E, Redden J, Rendahl A, Vickers Z, Reicks M. Impacts of a Vegetable Cooking Skills Program Among Low-Income Parents and Children. J Nutr Educ Behav. 2018 Sep;50(8):795-802. doi: 10.1016/j.jneb.2017.10.016. Epub 2017 Dec 12. — View Citation

Pinard CA, Yaroch AL, Hart MH, Serrano EL, McFerren MM, Estabrooks PA. The Validity and reliability of the Comprehensive Home Environment Survey (CHES). Health Promot Pract. 2014 Jan;15(1):109-17. doi: 10.1177/1524839913477863. Epub 2013 Mar 7. — View Citation

Polgar, J., S. Goldberg, and M. Haemer, An Economic Perspective On a Community-Based Childhood Obesity Treatment Program, in Colorado Public Health Forum. 2016: Aurora, CO

Prescott CA, McArdle JJ, Hishinuma ES, Johnson RC, Miyamoto RH, Andrade NN, Edman JL, Makini GK Jr, Nahulu LB, Yuen NY, Carlton BS. Prediction of major depression and dysthymia from CES-D scores among ethnic minority adolescents. J Am Acad Child Adolesc Psychiatry. 1998 May;37(5):495-503. doi: 10.1097/00004583-199805000-00012. — View Citation

Rabin BA, McCreight M, Battaglia C, Ayele R, Burke RE, Hess PL, Frank JW, Glasgow RE. Systematic, Multimethod Assessment of Adaptations Across Four Diverse Health Systems Interventions. Front Public Health. 2018 Apr 9;6:102. doi: 10.3389/fpubh.2018.00102. eCollection 2018. — View Citation

Resnicow K, Harris D, Wasserman R, Schwartz RP, Perez-Rosas V, Mihalcea R, Snetselaar L. Advances in Motivational Interviewing for Pediatric Obesity: Results of the Brief Motivational Interviewing to Reduce Body Mass Index Trial and Future Directions. Pediatr Clin North Am. 2016 Jun;63(3):539-62. doi: 10.1016/j.pcl.2016.02.008. — View Citation

Resnicow K, McMaster F, Bocian A, Harris D, Zhou Y, Snetselaar L, Schwartz R, Myers E, Gotlieb J, Foster J, Hollinger D, Smith K, Woolford S, Mueller D, Wasserman RC. Motivational interviewing and dietary counseling for obesity in primary care: an RCT. Pediatrics. 2015 Apr;135(4):649-57. doi: 10.1542/peds.2014-1880. — View Citation

Resnicow K, McMaster F, Woolford S, Slora E, Bocian A, Harris D, Drehmer J, Wasserman R, Schwartz R, Myers E, Foster J, Snetselaar L, Hollinger D, Smith K. Study design and baseline description of the BMI2 trial: reducing paediatric obesity in primary care practices. Pediatr Obes. 2012 Feb;7(1):3-15. doi: 10.1111/j.2047-6310.2011.00001.x. Epub 2011 Dec 13. — View Citation

Rich SS, DiMarco NM, Huettig C, Essery EV, Andersson E, Sanborn CF. Perceptions of health status and play activities in parents of overweight Hispanic toddlers and preschoolers. Fam Community Health. 2005 Apr-Jun;28(2):130-41. doi: 10.1097/00003727-200504000-00005. — View Citation

Ritzwoller DP, Sukhanova A, Gaglio B, Glasgow RE. Costing behavioral interventions: a practical guide to enhance translation. Ann Behav Med. 2009 Apr;37(2):218-27. doi: 10.1007/s12160-009-9088-5. Epub 2009 Mar 17. — View Citation

Runkle C, Osterholm A, Hoban R, McAdam E, Tull R. Brief negotiation program for promoting behavior change: the Kaiser Permanente approach to continuing professional development. Educ Health (Abingdon). 2000;13(3):377-86. doi: 10.1080/135762800750059499. — View Citation

S, A., et al., Boot Camp Translation for the Prevention of Type 2 Diabetes (T2D) in Fort Collins' Hispanic/Latino Adolescents., in CCTSI Community Engagement Conference. 2017

Sacher PM, Kolotourou M, Chadwick PM, Cole TJ, Lawson MS, Lucas A, Singhal A. Randomized controlled trial of the MEND program: a family-based community intervention for childhood obesity. Obesity (Silver Spring). 2010 Feb;18 Suppl 1:S62-8. doi: 10.1038/oby.2009.433. — View Citation

Schwartz RP, Hamre R, Dietz WH, Wasserman RC, Slora EJ, Myers EF, Sullivan S, Rockett H, Thoma KA, Dumitru G, Resnicow KA. Office-based motivational interviewing to prevent childhood obesity: a feasibility study. Arch Pediatr Adolesc Med. 2007 May;161(5):495-501. doi: 10.1001/archpedi.161.5.495. — View Citation

Scott SN, Springer CM, Oody JF, McClanahan MS, Wiseman BD, Kybartas TJ, Coe DP. Development and Validation of a PACER Prediction Equation for VO2peak in 10- to 15-Year-Old Youth. Pediatr Exerc Sci. 2019 May 1;31(2):223-228. doi: 10.1123/pes.2018-0136. Epub 2019 Jan 3. — View Citation

Shomaker LB, Pivarunas B, Annameier SK, Gulley L, Quaglia J, Brown KW, Broderick P, Bell C. One-Year Follow-Up of a Randomized Controlled Trial Piloting a Mindfulness-Based Group Intervention for Adolescent Insulin Resistance. Front Psychol. 2019 May 8;10:1040. doi: 10.3389/fpsyg.2019.01040. eCollection 2019. — View Citation

Soler J, Perez-Sola V, Puigdemont D, Perez-Blanco J, Figueres M, Alvarez E. [Validation study of the Center for Epidemiological Studies-Depression of a Spanish population of patients with affective disorders]. Actas Luso Esp Neurol Psiquiatr Cienc Afines. 1997 Jul-Aug;25(4):243-9. Spanish. — View Citation

Spear BA, Barlow SE, Ervin C, Ludwig DS, Saelens BE, Schetzina KE, Taveras EM. Recommendations for treatment of child and adolescent overweight and obesity. Pediatrics. 2007 Dec;120 Suppl 4:S254-88. doi: 10.1542/peds.2007-2329F. — View Citation

Steen, E., et al. Communication Characteristics of Parents of Latino Preschoolers that Predict Improved Readiness to Change for Child Weight After a Clinic Visit. in American Society for Nutrition. 2020. Seattle WA.

Stevens VJ, Glasgow RE, Toobert DJ, Karanja N, Smith KS. Randomized trial of a brief dietary intervention to decrease consumption of fat and increase consumption of fruits and vegetables. Am J Health Promot. 2002 Jan-Feb;16(3):129-34. doi: 10.4278/0890-1171-16.3.129. — View Citation

Turer CB, Stroo M, Brouwer RJ, Krause KM, Lovelady CA, Bastian LA, Peterson B, Ostbye T. Do high-risk preschoolers or overweight mothers meet AAP-recommended behavioral goals for reducing obesity? Acad Pediatr. 2013 May-Jun;13(3):243-50. doi: 10.1016/j.acap.2013.01.003. Epub 2013 Jan 9. — View Citation

Villarreal, R., S. Blozis, and K. Widaman, Factorial Invariance of a Pan-Hispanic Familism Scale. Hispanic Journal of Behavioral Sciences, 2005. 27: p. 409 - 425.

Weaver RG, Brazendale K, Hunt E, Sarzynski MA, Beets MW, White K. Disparities in childhood overweight and obesity by income in the United States: an epidemiological examination using three nationally representative datasets. Int J Obes (Lond). 2019 Jun;43(6):1210-1222. doi: 10.1038/s41366-019-0331-2. Epub 2019 Feb 4. — View Citation

Welk GJ, Meredith MD, Ihmels M, Seeger C. Distribution of health-related physical fitness in Texas youth: a demographic and geographic analysis. Res Q Exerc Sport. 2010 Sep;81(3 Suppl):S6-15. doi: 10.1080/02701367.2010.10599689. — View Citation

Welk, G.J. and M.D. Meredith, eds. Fitnessgram / Activitygram Reference Guide. 2008, The Cooper Institute.: Dallas, TX.

Zeller MH, Modi AC. Development and initial validation of an obesity-specific quality-of-life measure for children: sizing me up. Obesity (Silver Spring). 2009 Jun;17(6):1171-7. doi: 10.1038/oby.2009.47. Epub 2009 Mar 5. — View Citation

* Note: There are 88 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index (BMI) %95 in children with obesity (treatment)	Change in BMI%95 as measured in 2-16 yr old children with obesity BMI%95 is the percentage a child's BMI represents of the BMI value at the 95th percentile for age and sex calculated using the Centers for Disease Control (CDC) program for Statistical Analysis System (SAS).	From Baseline to Month 18
Primary	Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention)	Change in BMI%95 as measured in healthy and overweight 2-11 yr old siblings of the children with obesity. BMI%95 is the percentage a child's BMI represents of the BMI value at the 95th percentile for age and sex calculated using the CDC program for SAS.	From Baseline to Month 18
Secondary	Change in Body Mass Index (BMI) %95 in children with obesity (treatment)	Change in BMI%95 as measured in 2-16 yr old children with obesity BMI%95 is the percentage a child's BMI represents of the BMI value at the 95th percentile for age and sex calculated using the CDC program for SAS.	From Baseline to Month 12
Secondary	Change in Body Mass Index (BMI) %95 in healthy and overweight children (prevention)	Change in BMI%95 as measured in healthy and overweight 2-11 yr old siblings of the children with obesity. BMI%95 is the percentage a child's BMI represents of the BMI value at the 95th percentile for age and sex calculated using the CDC program for SAS.	From Baseline to Month 12
Secondary	Change in nutrition aspects of the home environment as measured by the Comprehensive Home Environment Survey (CHES)	The CHES is a validated parent-report instrument that measures aspects of the home environment influencing child diet and physical activity. Possible scores on the nutrition scale range from 0 to 10, with higher scores indicating a better home environment for nutrition.	Baseline, Month 18
Secondary	Change in physical activity and media aspects of the home environment as measured by the Comprehensive Home Environment Survey (CHES)	The CHES is a validated parent-report instrument that measures aspects of the home environment influencing physical activity and media. Possible scores are on a scale from 0 to 8 with higher scores indicating a better home environment for physical activity and media.	Baseline, Month 18
Secondary	Change from Baseline in food insecurity at 18 months as measured by the US Department of Agriculture (USDA) Household Food Security Survey scores	The USDA Household Food Security Survey is a validated scale that measures food insecurity. Possible scores range from 0 to 18, with higher scores indicating lower food security.	Baseline, Month 18
Secondary	Change from baseline in Hunger at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents	Three-Factor Eating Questionnaire for Children and Adolescents is a validated scale that measures eating attitudes and behaviors in 3 domains: 'Cognitive Restraint of Eating', 'Disinhibition', and 'Hunger'. Possible scores range from 0-14 for 'Hunger' with higher scores indicating worse eating attitudes and behaviors.	Baseline, Month 18
Secondary	Change from baseline in Cognitive Restraint of Eating at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents	Three-Factor Eating Questionnaire for Children and Adolescents is a validated scale that measures eating attitudes and behaviors in 3 domains: 'Cognitive Restraint of Eating', 'Disinhibition', and 'Hunger'. Possible scores range from 0-21 for 'Cognitive Restraint of Eating' with higher scores indicating worse eating attitudes and behaviors.	Baseline, Month 18
Secondary	Change from baseline in Disinhibition at 18 months as measured by the Three-Factor Eating Questionnaire for Children and Adolescents	Three-Factor Eating Questionnaire for Children and Adolescents is a validated scale that measures eating attitudes and behaviors in 3 domains: 'Cognitive Restraint of Eating', 'Disinhibition', and 'Hunger'. Possible scores range from 0-16 for 'Disinhibition' with higher scores indicating worse eating attitudes and behaviors.	Baseline, Month 18
Secondary	Change from baseline in physical fitness at 6 months as measured by the Progressive Aerobic Cardiovascular Endurance Run (PACER) Scores	The Progressive Aerobic Cardiovascular Endurance Run (PACER) test measures physical fitness by estimating VO2peak. Scores are based on a shuttle-run of 20 meter intervals. The higher the number of intervals completed in the allotted time indicating a better outcome.	Baseline, Month 6
Secondary	Change from baseline in physical fitness at 18 months as measured by the Progressive Aerobic Cardiovascular Endurance Run (PACER) Scores	The Progressive Aerobic Cardiovascular Endurance Run (PACER) test measures physical fitness by estimating VO2peak. Scores are based on a shuttle-run of 20 meter intervals. The higher the number of intervals completed in the allotted time indicating a better outcome.	Baseline, Month 18
Secondary	Change from Baseline in Hemoglobin A1c (HbA1c) blood glucose tests at 18 months	HbA1c blood glucose test, routinely measured as part of pediatric well child care for children 10 years and older with obesity, measures the average level of glucose in blood with normal range 4.2% to 5.6%, prediabetes range 5.7% to 6.4%, and =6.5% indicating diabetes. Higher numerical values above 5.7 indicate worse blood sugar control. Investigators will compare the mean A1c between the two groups.	Baseline up to Month 18
Secondary	Change from Baseline in Alanine Transaminase (ALT) liver enzyme levels tests at 18 months	ALT levels in the blood, routinely measured as part of pediatric well child care for children 10 years and older with obesity, is measured by milligrams per deciliter (mg/dl) with ALT>22mg/dL in females less than 18 years, and ALT >26 mg/dL in males less than 18 years indicating possible non-alcoholic fatty liver disease. Higher levels of ALT above these normal cutoffs may represent worsening liver disease. Investigators will compare the mean ALT between the two groups.	Baseline up to Month 18
Secondary	Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol tests or fasting lipids tests at 18 months	The LDL blood test, routinely measured as part of pediatric well child care for children 10 years and older with obesity, measures cholesterol with an LDL>110 mg/dL in children indicating a worse outcome such as increased long-term risk of heart disease. Higher levels of LDL above these normal cutoffs may represent higher risk of heart disease. Investigators will compare the mean LDL between the two groups.	Baseline up to Month 18
Secondary	Change from Baseline in Caregiver Waist Circumference (WC) at 12 months	Waist Circumference is measured to classify adults aged 20 or older into 3 health risk categories, low health risk, increased health risk, and high health risk. A higher waist circumference indicates a worse outcome.	Baseline, Month 12
Secondary	Change from Baseline in Caregiver Waist Circumference (WC) at 18 months	Waist Circumference is measured to classify adults aged 20 or older into 3 health risk categories, low health risk, increased health risk, and high health risk. A higher waist circumference indicates a worse outcome.	Baseline, Month 18
Secondary	Change from Baseline in Adult Caregiver Body Mass Index (BMI) at 12 months	Body Mass Index (BMI) is a person's weight in kilograms divided by the square of their height in meters. Scores between 18.5 and 24.9 indicate a healthy weight. A higher BMI indicates a worse outcome.	Baseline, Month 12
Secondary	Change from Baseline in Adult Caregiver Body Mass Index (BMI) at 18 months	Body Mass Index (BMI) is a person's weight in kilograms divided by the square of their height in meters. Scores between 18.5 and 24.9 indicate a healthy weight. A higher BMI indicates a worse outcome.	Baseline, Month 18
Secondary	Change from Baseline to 6 months in levels of Familism as measured by the Pan-Hispanic Familism Scale	The Pan-Hispanic Familism Scale is a validated scale that measures familism, a value system found within many Hispanic/Latino communities that emphasizes familial honor, respect, and mutual collaboration. Participants respond on a 5-point Likert scale from 1=Strongly disagree to 5=Strongly Agree. Higher Scores indicate a higher degree of adherence to Familism.	Baseline, Month 6
Secondary	Change from Baseline in 18 months in levels of Familism as measured by the Pan-Hispanic Familism Scale	The Pan-Hispanic Familism Scale is a validated scale that measures familism, a value system found within many Hispanic/Latino communities that emphasizes familial honor, respect, and mutual collaboration. Participants respond on a 5-point Likert scale from 1=Strongly disagree to 5=Strongly Agree. Higher Scores indicate a higher degree of adherence to Familism.	Baseline, Month 18
Secondary	Change from Baseline in weight-related quality of life at 6 months as measured by the Sizing Me Up child report	Sizing Me Up is a validated weight-related quality of life questionnaire for children aged 10 years and older. Possible scores range from 0 to 100 with higher scores indicating a better quality of life.	Baseline, Month 6
Secondary	Change from Baseline in weight-related quality of life at 18 months as measured by the Sizing Me Up child report	Sizing Me Up is a validated weight-related quality of life questionnaire for children aged 10 years and older. Possible scores range from 0 to 100 with higher scores indicating a better quality of life.	Baseline, Month 18
Secondary	Change from Baseline in weight-related quality of life at 6 months as measured by the Sizing Them Up Parent report	Sizing Them Up is a validated weight-related quality of life questionnaire for parents/primary caregivers of children 6 to 10 years of age. Possible scores range from 0 to 100 with higher scores indicating a better quality of life.	Baseline, Month 6
Secondary	Change from Baseline in weight-related quality of life at 18 months as measured by the Sizing Them Up Parent report	Sizing Them Up is a validated weight-related quality of life questionnaire for parents/primary caregivers of children 6 to 10 years of age. Possible scores range from 0 to 100 with higher scores indicating a better quality of life.	Baseline, Month 18
Secondary	Change from Baseline in depressive symptoms in parents at 6 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D)	The Center of Epidemiological Studies Depression Scale is a validated questionnaire that assesses depressive symptoms in parents. Possible scores range from 0-60 with higher scores indicating worse depressive symptoms.	Baseline, Month 6
Secondary	Change from Baseline in depressive symptoms in parents at 18 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D)	The Center of Epidemiological Studies Depression Scale is a validated questionnaire that assesses depressive symptoms in parents. Possible scores range from 0-60 with higher scores indicating worse depressive symptoms.	Baseline, Month 18
Secondary	Change from Baseline in depressive symptoms in adolescents 12-18 years at 6 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D)	The Center of Epidemiological Studies Depression Scale is a validated questionnaire that assesses depressive symptoms in adolescents 12-18 years. Possible scores range from 0-60 with higher scores indicating worse depressive symptoms.	Baseline, Month 6
Secondary	Change from Baseline in depressive symptoms in adolescents 12-18 years at 18 months as measured by the Center of Epidemiological Studies Depression Scale (CES-D)	The Center of Epidemiological Studies Depression Scale is a validated questionnaire that assesses depressive symptoms in adolescents 12-18 years. Possible scores range from 0-60 with higher scores indicating worse depressive symptoms.	Baseline, Month 18
Secondary	Change from Baseline in depressive symptoms in children at 6 months as measured by the Center of Epidemiological Studies Depression Scale for Children 6-12 years (CES-DC)	The Center of Epidemiological Studies Depression Scale for Children is a validated questionnaire that measures depressive symptoms in 6-12 year old children. Possible scores range from 0-60 with higher scores indicating worse depressive symptoms.	Baseline, Month 6
Secondary	Change from Baseline in depressive symptoms in children at 18 months as measured by the Center of Epidemiological Studies Depression Scale for Children 6-12 years (CES-DC)	The Center of Epidemiological Studies Depression Scale for Children is a validated questionnaire that measures depressive symptoms in 6-12 year old children. Possible scores range from 0-60 with higher scores indicating worse depressive symptoms.	Baseline, Month 18
Secondary	Reach as measured by the proportion of eligible children seen for well-child care that are randomized.	Reach as measured by the proportion of children seen for a well-child check at each clinic that are randomized during the study.	up to Month 18
Secondary	Adoption as measured by the proportion of training sessions attended by medical providers	Number of training sessions that Primary Care Providers attend. Attendance will be taken at all PCP trainings. There will be 4 training sessions within the first 12 months and 2 refresher training sessions between 36-48 months. Total 6 possible sessions attended, with higher attendance rates indicating a better outcome.	up to month 48
Secondary	Primary Care Visit Frequency in the as measured by number of clinic visits for each child	Primary Care Visit Frequency, as measured by the number of clinic visits for child weight follow-up reported in Clinic Electronic Medical Records (EMR's.	up to month 36
Secondary	Change in history of Coronavirus Disease 2019 (COVID-19) diagnosis status in a parent participant	Response to questionnaire administered every 6 months throughout the study period to participating parents querying whether they or any of their participating children have tested positive for COVID-19 using a laboratory assay. Participants with no history of COVID-19 diagnosis at baseline who later report positive diagnosis will be defined as new diagnosis of COVID-19 during the study period.	Baseline, up to month 18
Secondary	Change in history of COVID-19 diagnosis status in a child participant	Response to questionnaire administered every 6 months throughout the study period to participating parents querying whether any of their participating children have tested positive for COVID-19 using a laboratory assay. Child participants with no history of COVID-19 diagnosis at baseline whose parents later report positive diagnosis for that child will be defined as new diagnosis of COVID-19 during the study period.	Baseline, up to month 18

External Links

•   Cooper_Institute. FITNESSGRAM
•   Evidence Synthesis, No. 150: Screening for Obesity and Interventions for Weight Management in Children and Adolescents: A Systematic Evidence Review for the U.S. Preventive Services Task Force : Agency for Healthcare Research and Quality (US)
•   Pew Research Center - Hispanic Trends. Demographic and Economic Profiles of Hispanics by State and County, 2014. 2020
•   ServSafe. ServSafe - Food Safety Training. 2020 2020
•   Share_our_Strength. Cooking Matters Hands-On Cooking Courses. [web page] 2019
•   US_Census_Bureau. Detailed Languages Spoken at Home and Ability to Speak English for the Population 5 Years and Over: 2009-2013. 2015 Oct 28, 2015
•   USDA. Food Security in the U.S. - Survey Tools.