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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2017
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
n/a - observational study
n/a - observational study

Locations

Country Name City State
United States The Ohio State University Columbus Ohio
United States Purdue University West Lafayette Indiana

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University USDA North Central - Nutrition Education Center of Excellence

Country where clinical trial is conducted

United States, 

Outcome

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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