Childhood ObesitySWEATNCT03010644
Summer Weight and Environmental Assessment Trial
An observational study of Childhood Obesity, run by Ohio State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- n/a - observational study
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Racially and ethnically diverse convenience sample of disadvantaged school-age children
Who may be able to join
- School-aged children (rising kindergartners through rising 5th graders) attending schools in the target neighborhoods.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University
Columbus, Ohio, 43210
Purdue University
West Lafayette, Indiana, 47907
About this study
Official title: 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.
- Conditions
- Childhood Obesity
- Being tested
- n/a - observational study
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n/a - observational studyOther
n/a - observational study
| Study group | Role | What they receive |
|---|---|---|
| Underserved school-aged children | Underserved school-aged children at risk for obesity Receives: Other: n/a - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
Measured: Baseline (beginning of summer), T1 (5 weeks), T2 (10 weeks), T3 (22 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start1 May 2017
- Primary completion30 Nov 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- USDA North Central - Nutrition Education Center of Excellence
- Responsible party
- Principal investigator, Carolyn Gunther, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010644
- Sponsor's protocol ID
- 2016B0034
- Acronym
- SWEAT
- Status last verified
- Sep 2017
- First submitted
- 21 Dec 2016
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 32800759Hopkins 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.
PubMed 30158223
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Summer Weight and Environmental Assessment Trial (SWEAT)
- ClinicalTrials.gov ID
- NCT03010644
- Acronym / sponsor ID
- SWEAT / 2016B0034
- Conditions
- Childhood Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- USDA North Central - Nutrition Education Center of Excellence
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Underserved school-aged children | – | Other: n/a - observational studyUnderserved school-aged children at risk for obesity |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Racially and ethnically diverse convenience sample of disadvantaged school-age children
Key inclusion criteria (1 listed)
- School-aged children (rising kindergartners through rising 5th graders) attending schools in the target neighborhoods.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n/a - observational studyn/a - observational study | Other | Underserved school-aged children |
Primary outcome
Change in BMI
Time frame: Baseline (beginning of summer), T1 (5 weeks), T2 (10 weeks), T3 (22 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Derived from this study: PubMed 32800759Hopkins 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.
- Derived from this study: PubMed 30158223Hopkins 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI (time frame: Baseline (beginning of summer), T1 (5 weeks), T2 (10 weeks), T3 (22 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03010644, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.