NCT03010644

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 13, 2019

Status Verified

September 1, 2017

Enrollment Period

1.6 years

First QC Date

December 21, 2016

Last Update Submit

March 11, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in BMI

    Baseline (beginning of summer), T1 (5 weeks), T2 (10 weeks), T3 (22 weeks)

Study Arms (1)

Underserved school-aged children

Underserved school-aged children at risk for obesity

Other: n/a - observational study

Interventions

n/a - observational study

Underserved school-aged children

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Racially and ethnically diverse convenience sample of disadvantaged school-age children

You may qualify if:

  • School-aged children (rising kindergartners through rising 5th graders) attending schools in the target neighborhoods.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

  • Hopkins LC, Tiba S, Westrick M, Gunther C. The Diet Quality of a Sample of Predominantly Racial Minority Children From Low-Income Households Is Lower During the Summer vs School Year: Results From the Project Summer Weight and Environmental Assessment Trial Substudy. J Acad Nutr Diet. 2021 Jan;121(1):112-120. doi: 10.1016/j.jand.2020.06.013. Epub 2020 Aug 14.

  • Hopkins LC, Penicka C, Evich C, Jones B, Gunther C. Project SWEAT (Summer Weight and Environmental Assessment Trial): study protocol of an observational study using a multistate, prospective design that examines the weight gain trajectory among a racially and ethnically diverse convenience sample of economically disadvantaged school-age children. BMJ Open. 2018 Aug 29;8(8):e021168. doi: 10.1136/bmjopen-2017-021168.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 5, 2017

Study Start

May 1, 2017

Primary Completion

November 30, 2018

Study Completion

December 31, 2018

Last Updated

March 13, 2019

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations