Preventing Weight Gain and Unhealthy Behaviors in Children

NCT ID: NCT04608188

Last Updated: 2024-08-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2022-11-30

Brief Summary

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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

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Summer Program

Children in the intervention will attend a summer day camp operated at their school.

Group Type EXPERIMENTAL

Summer Camp

Intervention Type BEHAVIORAL

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.

No Program

The control children will not receive an intervention of any kind and will be asked to go about their summer as they typically would.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Summer Camp

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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R. Glenn Weaver

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37189190 (View on PubMed)

Weaver 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.

Reference Type DERIVED
PMID: 35378750 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00091526

Identifier Type: -

Identifier Source: org_study_id

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