Childhood Obesity Clinical Trial
— SWEATOfficial title:
Summer Weight and Environmental Assessment Trial (SWEAT)
NCT number | NCT03010644 |
Other study ID # | 2016B0034 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | December 31, 2018 |
Verified date | September 2017 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The consequences of childhood obesity are devastating, affecting the physical and mental health of children. Disadvantaged school-age children are at risk for unhealthy gains in BMI during the summer months and there is a dearth of information regarding the causal health behaviors and environmental factors. The overall objective of this application is to provide an in depth examination of key dietary and physical activity behaviors as well as the food, physical activity, and social environments of low-income, racial/ethnic school-age children. To achieve this goal, an observational study utilizing a multi-state prospective cohort design will be conducted with the goal of examining the weight gain trajectory among a racially and ethnically diverse convenience sample of disadvantaged school-age children who routinely attend structured programming during the summer months and those who don't participate in structured programming. In addition, a subset of these children will be evaluated to learn their daily health behaviors, as well as their food, physical activity, and social environments during the summer. Identification of determinants of program participation and factors that may enhance the beneficial effects of program participation will also occur. A social ecological framework approach will guide the research. This study can be expected to have a significant positive impact by providing information on the factors that protect disadvantaged children from unhealthy weight gain during the summer which can be used by stakeholders at the local, state, and federal level to reform current policy that will increase child participation in health promoting programming during the summer window of risk.
Status | Completed |
Enrollment | 152 |
Est. completion date | December 31, 2018 |
Est. primary completion date | November 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility |
Inclusion Criteria: - School-aged children (rising kindergartners through rising 5th graders) attending schools in the target neighborhoods. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
United States | Purdue University | West Lafayette | Indiana |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | USDA North Central - Nutrition Education Center of Excellence |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in BMI | Baseline (beginning of summer), T1 (5 weeks), T2 (10 weeks), T3 (22 weeks) |
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