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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04656496
Other study ID # STUDY000244
Secondary ID R01CA240319
Status Recruiting
Phase N/A
First received
Last updated
Start date December 8, 2020
Est. completion date November 30, 2025

Study information

Verified date November 2023
Source University of South Florida
Contact Marilyn Stern, PhD
Phone 813-974-0966
Email mstern1@usf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pediatric cancer survivors are at an increased risk of excessive weight gain and reduced exercise behaviors with the potential for this risk to worsen over time. With over 80% of pediatric cancer patients living to adulthood, many pediatric cancer survivors experience long-term health consequences such as heart disease - the leading cause of death in this population. The purpose of this clinical research study is to teach parents/caregivers skills that will help prevent and reduce the problems of obesity in childhood cancer survivors. In this study, parents have the opportunity to participate in one of two web-based groups in which parents in either group will learn valuable information to improve the health of their child and of themselves.


Description:

This project employs a cluster randomized, controlled, repeated measures trial study design, with parent-child dyads assigned to an evidence-informed manualized, social-cognitive parent intervention (NOURISH-T+) or to a comparison group (Enhanced Usual Care group - Brief NOURISH-T+). NOURISH-T+ stands for Nourishing Our Understanding of Role modeling to Improve Support and Health for Healthy Transitions. Parents of pediatric cancer survivors (ages 5-14 years) with overweight and obesity, and off treatment for at least 6 months will be recruited across multiple pediatric oncology clinic sites. The University of South Florida (USF) serves as the coordinating data management and centralized research and intervention team and will also recruit eligible participants from its pediatric oncology clinic. NOURISH-T+ targets parents as agents of change by providing intensive parent skills training emphasizing role modeling of positive health behaviors to foster the development of healthy eating and physical activity in pediatric cancer survivors. The NOURISH-T+ group will have 6 weekly, 1-1.5 hour, manualized sessions delivered using video-conferencing. There will be 2 additional brief sessions where the child will participate along with their parent to promote child engagement. Additionally, there will be one session with a pediatric oncology dietician based out of Nicklaus Children's Hospital who will discuss personalized nutritional strategies. Brief booster sessions at 2-, 4-, 8-, and 10- months will maximize retention and follow-up participation. NOURISH-T+ content is theory-based, manualized, and builds upon strengths of our prior work with NOURISH-T (our pilot) and NOURISH (our work with otherwise healthy overweight and obese children). Parents randomized to Brief NOURISH-T+ will participate in one information session moderated by a USF-based interventionist using videoconferencing. Session content is taken from the publicly available We Can! Manual. Parents in this group will receive nationally available web-based brochures on pediatric overweight/obesity on two occasions during the 6 weeks that NOURISH-T+ families participate in the study. Check-ins will take place at 2-, 4-, 8-, and 10- months post-intervention. Outcome measures will be completed at baseline, 3-, 6-, and 12-months post-intervention.


Recruitment information / eligibility

Status Recruiting
Enrollment 520
Est. completion date November 30, 2025
Est. primary completion date October 30, 2025
Accepts healthy volunteers No
Gender All
Age group 5 Years to 14 Years
Eligibility Inclusion Criteria: Eligible Pediatric Cancer Survivors must be: 1. 5-14 years of age at enrollment; 2. Off active treatment for at least 6 months; 3. At or above the 85th BMI %ile; 4. Able to complete assessments with the help of clinic staff and the USF research team; 5. Residing with the participating parent; 6. Able to engage in PA tailored to current medical status; 7. NOT taking medications that affect body weight (e.g., steroids) within 6 months of enrollment, and 8. In remission -- PCS who experience a relapse of cancer during the intervention will be excused from further involvement. 9. Must be English- or Spanish-speaking Participating Parents must: - Be either biological or adoptive and/or step mothers or fathers and must be permanent legal guardians of the PCS - Be at least 18 years old - Identifies as the main meal preparer at home - Must be English- or Spanish-speaking Exclusion Criteria: - Parents are ineligible if they are non-ambulatory and/or do not reside at least 50% of the time with their participating child. - Female parents who are currently pregnant will be excluded from the study. - Children are ineligible to participate if they are non-ambulatory. In addition, children who are wards of the state will be excluded from the study.

Study Design


Intervention

Behavioral:
NOURISH-T+
NOURISH-T+ (Nourishing Our Understanding of Role Modeling to Improve Support and Healthy - Transitions) is a 6 session, psychoeducational program designed to teach parents of childhood cancer survivors with overweight/obesity knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.
Brief NOURISH-T+
Enhanced Usual Care (or Brief NOURISH-T+) is an abbreviated version of the full NOURISH-T+ intervention in which parents are engaged in a one-time information session to also learn knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.

Locations

Country Name City State
United States Emory University Atlanta Georgia
United States Johns Hopkins Medicine Baltimore Maryland
United States University of Florida Health System Gainesville Florida
United States Hackensack Meridian Health Hackensack New Jersey
United States Nicklaus Children's Hospital Miami Florida
United States University of Miami Health System Miami Florida
United States Virginia Commonwealth University Richmond Virginia
United States Washington University School of Medicine Saint Louis Missouri
United States USF Pediatrics Tampa Florida
United States Children's National Hospital Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of South Florida National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (47)

Armstrong GT, Oeffinger KC, Chen Y, Kawashima T, Yasui Y, Leisenring W, Stovall M, Chow EJ, Sklar CA, Mulrooney DA, Mertens AC, Border W, Durand JB, Robison LL, Meacham LR. Modifiable risk factors and major cardiac events among adult survivors of childhood cancer. J Clin Oncol. 2013 Oct 10;31(29):3673-80. doi: 10.1200/JCO.2013.49.3205. Epub 2013 Sep 3. — View Citation

Bean MK, Wilson DB, Thornton LM, Kelly N, Mazzeo SE. Dietary intake in a randomized-controlled pilot of NOURISH: a parent intervention for overweight children. Prev Med. 2012 Sep;55(3):224-7. doi: 10.1016/j.ypmed.2012.06.016. Epub 2012 Jun 24. — View Citation

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Lipshultz SE, Adams MJ, Colan SD, Constine LS, Herman EH, Hsu DT, Hudson MM, Kremer LC, Landy DC, Miller TL, Oeffinger KC, Rosenthal DN, Sable CA, Sallan SE, Singh GK, Steinberger J, Cochran TR, Wilkinson JD; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Basic Cardiovascular Sciences, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Radiolo. Long-term cardiovascular toxicity in children, adolescents, and young adults who receive cancer therapy: pathophysiology, course, monitoring, management, prevention, and research directions: a scientific statement from the American Heart Association. Circulation. 2013 Oct 22;128(17):1927-95. doi: 10.1161/CIR.0b013e3182a88099. Epub 2013 Sep 30. No abstract available. Erratum In: Circulation. 2013 Nov 5;128(19):e394. — View Citation

Lydecker JA, Simpson C, Kwitowski M, Gow RW, Stern M, Bulik CM, Mazzeo SE. Evaluation of Parent-Reported Feeding Practices in a Racially Diverse, Treatment-Seeking Child Overweight/Obesity Sample. Child Health Care. 2017;46(3):265-281. doi: 10.1080/02739615.2016.1163489. Epub 2016 Mar 17. — View Citation

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Mazzeo S, Gow R, Stern M, Gerke C. Developing an intervention for parents of overweight children. International Journal of Child and Adolescent Health. 2008;1(4):355-363.

Mazzeo SE, Kelly NR, Stern M, Gow RW, Serdar K, Evans RK, Jones RM, Bulik CM. Nourishing Our Understanding of Role Modeling to Improve Support and Health (NOURISH): design and methods. Contemp Clin Trials. 2012 May;33(3):515-22. doi: 10.1016/j.cct.2012.01.003. Epub 2012 Jan 18. — View Citation

Moyer A, Knapp-Oliver SK, Sohl SJ, Schnieder S, Floyd AH. Lessons to be learned from 25 years of research investigating psychosocial interventions for cancer patients. Cancer J. 2009 Sep-Oct;15(5):345-51. doi: 10.1097/PPO.0b013e3181bf51fb. — View Citation

Nathan PC, Ford JS, Henderson TO, Hudson MM, Emmons KM, Casillas JN, Lown EA, Ness KK, Oeffinger KC. Health behaviors, medical care, and interventions to promote healthy living in the Childhood Cancer Survivor Study cohort. J Clin Oncol. 2009 May 10;27(14):2363-73. doi: 10.1200/JCO.2008.21.1441. Epub 2009 Mar 2. — View Citation

Ness KK, Leisenring WM, Huang S, Hudson MM, Gurney JG, Whelan K, Hobbie WL, Armstrong GT, Robison LL, Oeffinger KC. Predictors of inactive lifestyle among adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. Cancer. 2009 May 1;115(9):1984-94. doi: 10.1002/cncr.24209. — View Citation

Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, Friedman DL, Marina N, Hobbie W, Kadan-Lottick NS, Schwartz CL, Leisenring W, Robison LL; Childhood Cancer Survivor Study. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006 Oct 12;355(15):1572-82. doi: 10.1056/NEJMsa060185. — View Citation

Oeffinger KC, Mertens AC, Sklar CA, Yasui Y, Fears T, Stovall M, Vik TA, Inskip PD, Robison LL; Childhood Cancer Survivor Study. Obesity in adult survivors of childhood acute lymphoblastic leukemia: a report from the Childhood Cancer Survivor Study. J Clin Oncol. 2003 Apr 1;21(7):1359-65. doi: 10.1200/JCO.2003.06.131. — View Citation

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Raber M, Swartz MC, Santa Maria D, O'Connor T, Baranowski T, Li R, Chandra J. Parental involvement in exercise and diet interventions for childhood cancer survivors: a systematic review. Pediatr Res. 2016 Sep;80(3):338-46. doi: 10.1038/pr.2016.84. Epub 2016 Apr 11. — View Citation

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Ruble K, Davis CL, Han HR. Endothelial health in childhood acute lymphoid leukemia survivors: pilot evaluation with peripheral artery tonometry. J Pediatr Hematol Oncol. 2015 Mar;37(2):117-20. doi: 10.1097/MPH.0000000000000122. — View Citation

Ruble K, Scarvalone S, Gallicchio L, Davis C, Wells D. Group Physical Activity Intervention for Childhood Cancer Survivors: A Pilot Study. J Phys Act Health. 2016 Mar;13(3):352-9. doi: 10.1123/jpah.2015-0050. Epub 2015 Aug 13. — View Citation

Sklar CA, Mertens AC, Walter A, Mitchell D, Nesbit ME, O'Leary M, Hutchinson R, Meadows AT, Robison LL. Changes in body mass index and prevalence of overweight in survivors of childhood acute lymphoblastic leukemia: role of cranial irradiation. Med Pediatr Oncol. 2000 Aug;35(2):91-5. doi: 10.1002/1096-911x(200008)35:23.0.co;2-g. — View Citation

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Smith JD, Berkel C, Jordan N, Atkins DC, Narayanan SS, Gallo C, Grimm KJ, Dishion TJ, Mauricio AM, Rudo-Stern J, Meachum MK, Winslow E, Bruening MM. An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study). Implement Sci. 2018 Jan 15;13(1):11. doi: 10.1186/s13012-017-0697-2. — View Citation

Stern M, Bachar E, Ronen Ackerman E, Rancourt D, Bonne O, Weintraub M. Weight Trajectories of Israeli Pediatric Cancer Survivors. J Pediatr Psychol. 2017 Jun 1;42(5):588-597. doi: 10.1093/jpepsy/jsw102. — View Citation

Stern M, Bleck J, Ewing LJ, Davila E, Lynn C, Hale G, Mazzeo S. NOURISH-T: Targeting caregivers to improve health behaviors in pediatric cancer survivors with obesity. Pediatr Blood Cancer. 2018 May;65(5):e26941. doi: 10.1002/pbc.26941. Epub 2018 Jan 19. — View Citation

Stern M, Ewing L, Davila E, Thompson AL, Hale G, Mazzeo S. Design and rationale for NOURISH-T: a randomized control trial targeting parents of overweight children off cancer treatment. Contemp Clin Trials. 2015 Mar;41:227-37. doi: 10.1016/j.cct.2014.12.018. Epub 2015 Jan 2. — View Citation

Stern, M., Lamanna, J., Russell, C., Ewing, L., Thompson, A., Trapp, S., Bitsko, M., & Mazzeo, S. (2013). Adaptation of an obesity intervention program for pediatric cancer survivors (NOURISH-T). Clinical Practice in Pediatric Psychology, 1(3), 264-275. https://doi.org/10.1037/cpp0000023

Stern, M., Mazzeo, S.E., Porter, J. et al. Self-Esteem, Teasing and Quality of Life: African American Adolescent Girls Participating in a Family-Based Pediatric Overweight Intervention. J Clin Psychol Med Settings 13, 217 (2006). https://doi.org/10.1007/s10880-006-9029-4

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* Note: There are 47 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Child BMI z-score Height and weight will be measured to obtain BMI z-score for gender and age. baseline to 6 months
Primary Change in Child BMI z-score Height and weight will be measured to obtain BMI z-score for gender and age. baseline to 12 months
Secondary Change in Child Physical Activity Behaviors Waist-worn accelerometers will be worn for one week to calculate average daily step count over one week. Accelerometers objectively measure daily PA, including average steps per day, time spent in moderate-vigorous activity, and sedentary time. baseline to 6 months
Secondary Change in Child Physical Activity Behaviors Waist-worn accelerometers will be worn for one week to calculate average daily step count over one week. Accelerometers objectively measure daily PA, including average steps per day, time spent in moderate-vigorous activity, and sedentary time. baseline to 12 months
Secondary Change in Child Eating Behaviors Dietary Recall Automated Self-administered 24-Hour Dietary Recall-2020(ASA24). ASA24 is a highly reliable, computer assisted 24-hour dietary recall interview with animated guides and audio and visual cues to instruct participants and enhance use in low-literacy populations. baseline to 6 months
Secondary Change in Child Eating Behaviors Dietary Recall Automated Self-administered 24-Hour Dietary Recall-2020(ASA24). ASA24 is a highly reliable, computer assisted 24-hour dietary recall interview with animated guides and audio and visual cues to instruct participants and enhance use in low-literacy populations. baseline to 12 months
Secondary Change in Parent BMI Height and weight will be measured and used to calculate continuous adult BMI score. baseline to 6 months
Secondary Change in Parent BMI Height and weight will be measured and used to calculate continuous adult BMI score. baseline to 12 months
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