- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03010644
Summer Weight and Environmental Assessment Trial (SWEAT)
March 11, 2019 updated by: Carolyn Gunther, Ohio State University
Summer Weight and Environmental Assessment Trial (SWEAT)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
152
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue University
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Racially and ethnically diverse convenience sample of disadvantaged school-age children
Description
Inclusion Criteria:
- School-aged children (rising kindergartners through rising 5th graders) attending schools in the target neighborhoods.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Underserved school-aged children
Underserved school-aged children at risk for obesity
|
n/a - observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in BMI
Time Frame: Baseline (beginning of summer), T1 (5 weeks), T2 (10 weeks), T3 (22 weeks)
|
Baseline (beginning of summer), T1 (5 weeks), T2 (10 weeks), T3 (22 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
November 30, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
December 21, 2016
First Submitted That Met QC Criteria
January 3, 2017
First Posted (Estimate)
January 5, 2017
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016B0034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Childhood Obesity
-
Universiteit LeidenWageningen University; Nutricia, Inc.; Danone ResearchCompletedChildhood Obesity | Childhood Overweight | Vegetable Acceptance in Early ChildhoodNetherlands
-
Cornell UniversityCompletedChildhood Obesity Prevention
-
Universidad de SonoraCentro de Investigación en Alimentación y Desarrollo A.C.; Instituto Nacional...Not yet recruitingChildhood Obesity Pevention
-
Tehran University of Medical SciencesUnknownChildhood Obesity PreventionIran, Islamic Republic of
-
Universidad Autonoma de Nuevo LeonUniversidad de la SabanaCompletedPrevention Childhood ObesityMexico
-
Oregon State UniversityCompletedChildhood Obesity Prevention
-
The Miriam HospitalHassenfeld Child Health Innovation InstituteCompletedChildhood Obesity PreventionUnited States
-
Fundacion para la Formacion e Investigacion Sanitarias...UnknownChildhood Obesity PreventionSpain
-
Tampere UniversitySeinajoki Central Hospital; Tampere University Hospital; Foundation for Paediatric... and other collaboratorsCompleted
-
Harokopio UniversityCompletedPrevention of Childhood ObesityGreece
Clinical Trials on n/a - observational study
-
VASCage GmbHMedical University Innsbruck; St John of God Hospital, ViennaRecruiting
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
University College DublinUniversity College CorkCompletedFood Consumption Database AnalysisIreland
-
George Clinical Pty LtdActelion; The George InstituteCompletedTreatment Resistant Hypertension
-
Center for Eye Research AustraliaRecruitingAge-related Macular Degeneration | Geographic Atrophy | Age Related Macular Degeneration | AMDAustralia
-
University of California, San FranciscoNational Institute of Neurological Disorders and Stroke (NINDS)Completed
-
3Shape A/SNew York UniversityNot yet recruitingCaries,Dental | Caries; Initial | Caries Assessment | Caries Active | Caries Root
-
University of Texas at AustinEnrolling by invitation
-
University of North Carolina, CharlotteEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting
-
National Research Institute for Family Planning...West China Second University HospitalActive, not recruitingNon-alcoholic Fatty Liver Disease | Birth Defects | Overweight and Obesity | Child Development | Fertility | Environmental Exposure | Growth Retardation | Adverse Pregnancy Outcomes | Metabolic Abnormality | Health Problems in PregnancyChina