Obesity Clinical Trial
Official title:
"Get Fruved:" A Peer-led, Train-the-trainer Social Marketing Intervention to Increase Fruit and Vegetable Intake and Prevent Childhood Obesity.
Verified date | January 2020 |
Source | The University of Tennessee, Knoxville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This program is a non-diet approach to obesity prevention for older adolescents which does not promote following a special diet to manage weight; it promotes healthy behavior associated with obesity prevention. This approach is important with youth and older adolescent populations to avoid impairment in emotional well-being associated with body dissatisfaction. Healthy weight status will be achieved by improving dietary intake patterns, increasing physical activity, and improving stress management. Fall of year 01 was devoted to the recruitment of student partners (intense intervention group) and the development of partnerships. In the spring of year 01, recruited students were enrolled in two newly developed undergraduate courses across four intervention state partners, became collegiate 4-H members, planned a social marketing campaign, and/or learned to be peer mentors or student researchers. In year 02, first year college students were recruited, peer mentors were matched with a group of first year students, and the developed social marketing campaign was pilot tested on four college campuses (diffuse intervention) by the collegiate 4-H teams. In year 02, a toolkit with 24 weeks of intervention activities was also refined. In year 03, the collegiate 4-H team (intense intervention group) used the refined toolkit to test and implement the intervention on college campuses. In year 03, the assessment process for high school 4-H students (intense intervention group) will be pilot tested and college students will work with the high school students on adapting the toolkit for use in the implementation of the social marketing campaign in high school settings in year 04 (diffuse intervention). ). In year 04, the pilot and feasibility tested college intervention was tested with a randomized control trial design with 30 intervention and 29 control university partners. The adapted high school toolkit was pilot and feasibility tested in three intervention and two control high school settings. In year 05, the high school intervention was tested with a randomized control trial design with 9 intervention and 7 control high schools in one district's high schools. On all measures it is anticipated that participants in the intensive intervention group will have greater improvements than those in the diffuse intervention group and both intensive and diffuse intervention groups will have improvements over those in the control groups.
Status | Active, not recruiting |
Enrollment | 5800 |
Est. completion date | July 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 24 Years |
Eligibility |
Inclusion criteria: - Students in the intensive intervention group must be registered for a general/survey nutrition or wellness course - Students in the diffuse intervention group randomly selected from those who screen in because they are at increased health risk (increased BMI and waist circumference, low intakes of fruits and vegetables, high levels of stress, and low levels of physical activity) Exclusion criteria: - There are no exclusionary criteria for students in the intensive intervention group - Students who are not at-risk for health issues are excluded from the diffuse intervention group |
Country | Name | City | State |
---|---|---|---|
United States | South Dakota State University | Brookings | South Dakota |
United States | University of Florida | Gainesville | Florida |
United States | University of Tennessee | Knoxville | Tennessee |
United States | Kansas State University | Manhattan | Kansas |
United States | West Virginia University | Morgantown | West Virginia |
United States | University of Maine | Orono | Maine |
United States | Syracuse University | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
The University of Tennessee, Knoxville | Auburn University, Kansas State University, South Dakota State University, Syracuse University, United States Department of Agriculture (USDA), University of Florida, University of Maine, West Virginia University |
United States,
Byrd-Bredbenner C, Johnson M, Quick VM, Walsh J, Greene GW, Hoerr S, Colby SM, Kattelmann KK, Phillips BW, Kidd T, Horacek TM. Sweet and salty. An assessment of the snacks and beverages sold in vending machines on US post-secondary institution campuses. Appetite. 2012 Jun;58(3):1143-51. doi: 10.1016/j.appet.2012.02.055. Epub 2012 Mar 10. — View Citation
Do M, Kattelmann K, Boeckner L, Greene G, White A, Hoerr S, Horacek T, Lohse B, Phillips B, Nitzke S. Low-income young adults report increased variety in fruit and vegetable intake after a stage-tailored intervention. Nutr Res. 2008 Aug;28(8):517-22. doi: 10.1016/j.nutres.2008.05.013. — View Citation
Gordon R, McDermott L, Stead M, Angus K. The effectiveness of social marketing interventions for health improvement: what's the evidence? Public Health. 2006 Dec;120(12):1133-9. Epub 2006 Nov 13. Review. — View Citation
Gracia-Marco L, Vicente-Rodríguez G, Borys JM, Le Bodo Y, Pettigrew S, Moreno LA. Contribution of social marketing strategies to community-based obesity prevention programmes in children. Int J Obes (Lond). 2011 Apr;35(4):472-9. doi: 10.1038/ijo.2010.221. Epub 2010 Oct 26. Review. — View Citation
Greene GW, Schembre SM, White AA, Hoerr SL, Lohse B, Shoff S, Horacek T, Riebe D, Patterson J, Phillips BW, Kattelmann KK, Blissmer B. Identifying clusters of college students at elevated health risk based on eating and exercise behaviors and psychosocial determinants of body weight. J Am Diet Assoc. 2011 Mar;111(3):394-400. doi: 10.1016/j.jada.2010.11.011. — View Citation
Horacek TM, Erdman MB, Byrd-Bredbenner C, Carey G, Colby SM, Greene GW, Guo W, Kattelmann KK, Olfert M, Walsh J, White AB. Assessment of the dining environment on and near the campuses of fifteen post-secondary institutions. Public Health Nutr. 2013 Jul;16(7):1186-96. doi: 10.1017/S1368980012004454. Epub 2012 Oct 17. — View Citation
Horacek TM, White AA, Greene GW, Reznar MM, Quick VM, Morrell JS, Colby SM, Kattelmann KK, Herrick MS, Shelnutt KP, Mathews A, Phillips BW, Byrd-Bredbenner C. Sneakers and spokes: an assessment of the walkability and bikeability of U.S. postsecondary institutions. J Environ Health. 2012 Mar;74(7):8-15; quiz 42. — View Citation
O'Toole TP, Aaron KF, Chin MH, Horowitz C, Tyson F. Community-based participatory research: opportunities, challenges, and the need for a common language. J Gen Intern Med. 2003 Jul;18(7):592-4. — View Citation
Schultz JT, Moodie M, Mavoa H, Utter J, Snowdon W, McCabe MP, Millar L, Kremer P, Swinburn BA. Experiences and challenges in implementing complex community-based research project: the Pacific Obesity Prevention in Communities project. Obes Rev. 2011 Nov;12 Suppl 2:12-9. doi: 10.1111/j.1467-789X.2011.00911.x. — View Citation
Szymona K, Quick V, Olfert M, et al. The University Environment: A Comprehensive Assessment of Health-Related Advertisements. Health Ed. 2012;112(6):497-512.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body weight | Following an overnight fast and voiding, weight is measured in light clothing without shoes and with pockets emptied. Weight is measured in duplicate (average used unless > 0.1 kg difference requiring re-measurement until 2 values within range are achieved) to the nearest 0.1 kilograms using a calibrated electronic scale by trained assessors. Height without shoes is measured to the nearest 0.1 centimeter using a portable stadiometer. Height and weight are used to calculate BMI. | Change in body weight from baseline to six months and one year follow up | |
Secondary | Amount of physical activity | The International Physical Activity Questionnaire (IPAQ) is used to measure self-reported physical activity. Results are calculated as Metabolic Equivalent (MET) minutes/week and can be used to estimate energy expenditure. | Change in amount of physical activity from baseline to six months and one year follow up | |
Secondary | Dietary quality | The Automated Self-Administered Recall System (ASA24) is a web-based tool that allows participants to complete 24-hour recalls online. The Researcher Web site is used to incorporate the recall process in assessments and analyze data. Subjects complete the initial 24-hour recall at the time of the in-person physical assessment. They then receive email prompts asking them to completed two follow-up 24 hour recalls within the same week for a total of two recalls on nonconsecutive weekdays and one weekend day. | Change in dietary quality from baseline to six months and one year follow up | |
Secondary | Fruit and vegetable intake | Cups of fruits and vegetables/day is assessed using the NCI Fruit and Vegetable Screener (FVS). The FVS is a 19-item instrument that includes assessment of portion size. | Change in fruit and vegetable intake from baseline to six months and one year follow up | |
Secondary | Body composition | All circumference measurements are done using a Gulick tape measure. The waist is measured at the level of the iliac crests. The hips are measured at the maximum extension of the buttocks, and used to calculate body adiposity index (9) and hip to waist ratio. The neck is measured at the level of the Adams apple which can be palpated to identify location. | Change in body composition from baseline to six months and one year follow up | |
Secondary | Eating competence | Eating competence is measured using ecSatter Inventory (ecSI). The ecSI consists of 16 items that measure eating attitudes, food acceptance, internal regulation, and contextual skills such as meal planning. Those who have higher eating competence scores are more likely to be satisfied with weight, have lower BMI, and consume more fruits and vegetables than those with lower eating competence scores. | Change in eating competence from baseline to six months and one year follow up | |
Secondary | Stress | Perceived stress is measured Cohen's Perceived Stress Scale (PSS). The PSS is a 14 item instrument designed to measure the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. | Change in stress from baseline to six months and one year follow up | |
Secondary | Behavior changeability | The Behavioral Environmental Changeability Survey (BECS) was developed and is used to assess perceptions of the importance and willingness to change weight related behavior. The BECS consists of eight scales (Nutrition Changeability; Nutrition Behavior; Environmental Changeability; Program Importance and Changeability; Exercise Behavior; Sleep Behavior and Importance; Weight Loss; and Alcohol Intake). | Change in perceptions and willingness to change from baseline to six months and one year follow up | |
Secondary | Sleep | Quality and quantity of sleep are assessed using the Pittsburg Sleep Quality Index (PSQI). The survey has 19 self-reported items related to sleep over the past month. The items generate seven component scores (sleep quality, sleep latency, duration, efficiency, disturbances, use of sleeping medication and daytime dysfunction) which are summed for a global PSQI score. | Change in sleep from baseline to six months and one year follow up | |
Secondary | Campus healthy food access | Changes in overall consumption of all foods on campus are evaluated by reviewing the ordering records (with control for total student population) and sales data for all vending and dining services. | Change in campus food choice from baseline to six months and one year follow up | |
Secondary | Environmental change | The changes in the environment are assessed using the Healthy Campus Audit and the CEPS. The HCA assesses physical activity, food, and policy aspects of the environment. | Change in the campus environment from baseline to six months and one year follow up | |
Secondary | Recreational facility usage | The use of the recreational facilities are assessed through reviewing entrance records (with control for total student population). | Change in recreational facility usage from baseline to six months and one year follow up |
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