ObesityNCT04608188
Preventing Weight Gain and Unhealthy Behaviors in Children
A study testing Summer Camp in people with Obesity, run by University of South Carolina at 1 site in United States.
Trial summary
This study will address engagement in unhealthy behaviors, low levels of self-regulation, and unhealthy weight gain for children from low-income households. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Obesity
- What is being tested?
- Summer Camp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- participants will be boys and girls that attend one of the participating schools
- indicates "yes' on an informed consent document for participation in the study
Who cannot join
- diagnosis of an intellectual disability, such as Down Syndrome, Fragile X, Fetal Alcohol and/or a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance.
- children who plan to enroll in a summer camp during the year that they participate in the study will also be excluded from the study.
- No other exclusion criteria will be used.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29205
About this study
Official title: An Intervention to Prevent Weight Gain and Unhealthy Behaviors in Children From Economically Disadvantaged Circumstances
This study will address engagement in unhealthy behaviors, low levels of self-regulation, and unhealthy weight gain for children from low-income households.
Read the detailed description
Evidence suggests that components within structured days (e.g., school days) have a positive influence on children's obesogenic behaviors (i.e., diet, sleep, physical activity, sedentary behaviors) and self-regulation. In this pilot study children will be randomized to two arms: attend a structured summer camp, not attend a camp. The investigators hypothesize that children attending the summer camp will engage in more healthy obesogenic behaviors, display higher levels of self-regulation, and subsequently will experience less weight gain than children not attending the summer camp. To test this hypothesis the following specific aims will be accomplished: Aim 1 (Primary): Compare changes in BMI z-scores and fitness among children from low-income households attending a structured summer day camp and those not attending a structured summer day camp. Aim 2 (Secondary): Compare changes in obesogenic behaviors among children attending a structured summer day camp and those not attending a structured summer day camp. Aim 3 (Exploratory): Explore changes in self-regulation and the moderating effect of these changes on primary and secondary outcomes among children attending and not attending a structured summer day camp.
- Conditions
- Obesity
- Being tested
- Summer Camp
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summer CampBehavioural
The intervention camps will operate according to routine practice, with no assistance from the investigative team. The camps provide indoor and outdoor opportunities for children to be physically active each day, provide enrichment and academic programming, as well as provide breakfast, lunch, and snacks. All camp meals will adhere to the United States Department of Agriculture Summer Food Service Program nutrition guidelines. The camps employ 1 staff member for every 12 children - which is consistent with childcare regulations in the state of operation and operate daily (Mon-Fri) for 8 weeks during the summer. The camps open at 7am and close 6 pm daily.
| Study group | Role | What they receive |
|---|---|---|
| Summer Program | Experimental | Children in the intervention will attend a summer day camp operated at their school. Receives: Behavioral: Summer Camp |
| No Program | No intervention | The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index Z-score
Measure Description: Centers for Disease Control age and sex-specific Body Mass Index z-scores. A z-score of 0 represents the population mean. Higher or lower z-scores could represent better or worse outcomes as too low could be underweight and too high could indicate overweight or obesity.
Children above the 85th percentile are considered overweight while children above the 95th percentile are considered obese
Measured: End of school year (start of summer - baseline), beginning of the following school year (3 month)
Secondary outcomes (3)
Change in Inhibit BRIEF Subscale
The Behavior Rating Inventory of Executive Function was developed to provide a window into the everyday behavior associated with specific domains of the executive functions. This can be described as the ability to resist impulses and the ability to stop one's own behavior at the appropriate time. For T-score values 50 indicates the population mean with a standard deviation of 10 higher scores represent a worse outcome.
Measured: End of school year (start of summer - baseline), beginning of the following school year (3 month)
Change in Monitor BRIEF Subscale
The Behavior Rating Inventory of Executive Function measures Task-oriented monitoring or work-checking habits and Self-monitoring or interpersonal awareness. The task monitoring portion of the scale captures whether a child assesses his or her own performance during tasks to ensure accuracy. The self-monitoring portion of the scale evaluates whether a child keeps track of the effect that his or her behavior has on others. For T-score values 50 indicates the population mean with a standard deviation of 10 higher scores represent a worse outcome.
Measured: End of school year (start of summer - baseline), beginning of the following school year (3 month)
Change in Emotional Control BRIEF Subscale
The Behavior Rating Inventory of Executive Function measures The Emotional Control scale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. For T-score values 50 indicates the population mean with a standard deviation of 10 higher scores represent a worse outcome.
Measured: End of school year (start of summer - baseline), beginning of the following school year (3 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start15 Nov 2020
- Primary completion31 Jul 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Glenn Weaver, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608188
- Sponsor's protocol ID
- Pro00091526
- Status last verified
- Aug 2024
- First submitted
- 21 Oct 2020
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weaver RG, Armstrong B, Adams E, Beets MW, White J, Flory K, Wilson D, McLain A, Tennie B. Feasibility and preliminary efficacy of structured programming and a parent intervention to mitigate accelerated summer BMI gain: a pilot study. Pilot Feasibility Stud. 2023 May 15;9(1):83. doi: 10.1186/s40814-023-01312-3.
PubMed 37189190Weaver RG, Armstrong B, Adams E, Beets M, White J, Flory K, Wilson D, Mclain A, Tennie B. Feasibility & Preliminary Efficacy of Structured Programming and a Parent Intervention to Mitigate Accelerated Summer BMI Gain: A pilot study. Res Sq [Preprint]. 2022 Mar 29:rs.3.rs-1466063. doi: 10.21203/rs.3.rs-1466063/v1.
PubMed 35378750
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Prevent Weight Gain and Unhealthy Behaviors in Children From Economically Disadvantaged Circumstances
- ClinicalTrials.gov ID
- NCT04608188
- Acronym / sponsor ID
- Pro00091526
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will address engagement in unhealthy behaviors, low levels of self-regulation, and unhealthy weight gain for children from low-income households.
Detailed description
Evidence suggests that components within structured days (e.g., school days) have a positive influence on children's obesogenic behaviors (i.e., diet, sleep, physical activity, sedentary behaviors) and self-regulation. In this pilot study children will be randomized to two arms: attend a structured summer camp, not attend a camp. The investigators hypothesize that children attending the summer camp will engage in more healthy obesogenic behaviors, display higher levels of self-regulation, and subsequently will experience less weight gain than children not attending the summer camp. To test this hypothesis the following specific aims will be accomplished: Aim 1 (Primary): Compare changes in BMI z-scores and fitness among children from low-income households attending a structured summer day camp and those not attending a structured summer day camp. Aim 2 (Secondary): Compare changes in obesogenic behaviors among children attending a structured summer day camp and those not attending a structured summer day camp. Aim 3 (Exploratory): Explore changes in self-regulation and the moderating effect of these changes on primary and secondary outcomes among children attending and not attending a structured summer day camp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Summer Program | Experimental | Behavioral: Summer CampChildren in the intervention will attend a summer day camp operated at their school. |
| No Program | No intervention | –The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- participants will be boys and girls that attend one of the participating schools
- indicates "yes' on an informed consent document for participation in the study
Key exclusion criteria (3 listed)
- diagnosis of an intellectual disability, such as Down Syndrome, Fragile X, Fetal Alcohol and/or a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance.
- children who plan to enroll in a summer camp during the year that they participate in the study will also be excluded from the study.
- No other exclusion criteria will be used.
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 |
|---|---|---|
| Summer CampThe intervention camps will operate according to routine practice, with no assistance from the investigative team. The camps provide indoor and outdoor opportunities for children to be physically active each day, provide enrichment and academic programming, as well as provide breakfast, lunch, and snacks. All camp meals will adhere to the United States Department of Agriculture Summer Food Service Program nutrition guidelines. The camps employ 1 staff member for every 12 children - which is consistent with childcare regulations in the state of operation and operate daily (Mon-Fri) for 8 weeks during the summer. The camps open at 7am and close 6 pm daily. | Behavioural | Summer Program |
Primary outcome
Change in Body Mass Index Z-score
Time frame: End of school year (start of summer - baseline), beginning of the following school year (3 month)
Measure Description: Centers for Disease Control age and sex-specific Body Mass Index z-scores. A z-score of 0 represents the population mean. Higher or lower z-scores could represent better or worse outcomes as too low could be underweight and too high could indicate overweight or obesity. Children above the 85th percentile are considered overweight while children above the 95th percentile are considered obese
3 secondary outcomes
Change in Inhibit BRIEF Subscale
Time frame: End of school year (start of summer - baseline), beginning of the following school year (3 month)
Change in Monitor BRIEF Subscale
Time frame: End of school year (start of summer - baseline), beginning of the following school year (3 month)
Change in Emotional Control BRIEF Subscale
Time frame: End of school year (start of summer - baseline), beginning of the following school year (3 month)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37189190Weaver RG, Armstrong B, Adams E, Beets MW, White J, Flory K, Wilson D, McLain A, Tennie B. Feasibility and preliminary efficacy of structured programming and a parent intervention to mitigate accelerated summer BMI gain: a pilot study. Pilot Feasibility Stud. 2023 May 15;9(1):83. doi: 10.1186/s40814-023-01312-3.
- Derived from this study: PubMed 35378750Weaver RG, Armstrong B, Adams E, Beets M, White J, Flory K, Wilson D, Mclain A, Tennie B. Feasibility & Preliminary Efficacy of Structured Programming and a Parent Intervention to Mitigate Accelerated Summer BMI Gain: A pilot study. Res Sq [Preprint]. 2022 Mar 29:rs.3.rs-1466063. doi: 10.21203/rs.3.rs-1466063/v1.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Summer Camp in people with Obesity, run by University of South Carolina at 1 site 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 2 inclusion and 3 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 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Body Mass Index Z-score (time frame: End of school year (start of summer - baseline), beginning of the following school year (3 month)). 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 NCT04608188, 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 19 Aug 2024.