Preventing Weight Gain and Unhealthy Behaviors in Children

NCT04608188 | Completed Results DMC

• 1 other identifier: Pro00091526
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This study will address engagement in unhealthy behaviors, low levels of self-regulation, and unhealthy weight gain for children from low-income households.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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

  End of school year (start of summer - baseline), beginning of the following school year (3 month)

Secondary Outcomes (3)

• Change in Inhibit BRIEF Subscale

  End of school year (start of summer - baseline), beginning of the following school year (3 month)

• Change in Monitor BRIEF Subscale

  End of school year (start of summer - baseline), beginning of the following school year (3 month)

• Change in Emotional Control BRIEF Subscale

  End of school year (start of summer - baseline), beginning of the following school year (3 month)

Study Arms (2)

Summer Program

EXPERIMENTAL

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

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.

Interventions

Summer Camp 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.

Summer Program

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29205, United States

Location

Related Publications (2)

• 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.

  PMID: 37189190 DERIVED

• 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.

  PMID: 35378750 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robert Weaver
• Organization: University of South Carolina

weaverrg@mailbox.sc.edu

8037775605

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 29, 2020
• Study Start: November 15, 2020
• Primary Completion: July 31, 2022
• Study Completion: November 30, 2022
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)