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NCT02908230 Clinical Trial

Camp NERF: Methods of a Summer Nutrition Ed Rec & Fitness Program to Prevent Unhealthy Weight Gain in Children

Childhood Obesity Clinical Trial

Official title:
Camp NERF: Methods of a Theory-Based Nutrition Education Recreation and Fitness Program Aimed at Preventing Unhealthy Weight Gain in Underserved Elementary Children During Summer Months

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02908230
Other study ID # 2014B0197
Secondary ID
Status Completed
Phase N/A
First received September 16, 2016
Last updated September 19, 2016
Start date May 2015
Est. completion date August 2015

Study information
Verified date September 2016
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The primary aims of this research project are to:

1. Evaluate the efficacy of Camp NERF to improve child nutrition, physical activity, mental health, and anthropometric outcomes.

2. Evaluate the efficacy of Camp NERF to improve caregiver self-efficacy for establishing healthy family nutrition and physical activity practices, amount of physical activity, and BMI.

3. Evaluate the efficacy of Camp NERF to improve youth mentor nutrition, physical activity, and anthropometric outcomes.

Description:

Background: The number of obese children in the US remains high, which is problematic due to the mental, physical, and academic effects of obesity on child health. Data indicate that school-age children, particularly underserved children, experience unhealthy gains in BMI at a rate nearly twice as fast during the summer months. Few efforts have been directed at implementing evidence-based programming to prevent excess weight gain during the summer recess.

Methods: Camp NERF is an 8-week, multi-component (nutrition, physical activity, and mental health), theory-based program for underserved school-age children in grades Kindergarten - 5th grade coupled with the USDA Summer Food Service Program. Twelve eligible elementary school sites will be randomized to one of the three programming groups: 1) Active Control (non-nutrition, physical activity, or mental health [4H curricula]); 2) Standard Care (nutrition and physical activity); or 3) Enhanced Care (nutrition, physical activity, and mental health) programming. Anthropometric, behavioral, and psychosocial data will be collected from child-caregiver dyads pre- and post-intervention. Site-specific characteristics and process evaluation measures will also be collected.

Discussion: This is the first, evidence-based intervention to address the issue of weight gain during the summer months among underserved, school-aged children. Results from this study will provide researchers, practitioners, and public health professionals with insight on evidence-based programming to aid in childhood obesity prevention during this particular window of risk.

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years to 12 Years
Eligibility Inclusion Criteria (site level):

- Elementary school; USDA Summer Food Service Program open site; and 3) lacking structured programming

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Enhanced Care
8-week (nutrition, physical activity, and mental health) summer curriculum/program
• Standard Care
8-week (nutrition and physical activity) summer curriculum/program
• Active Control
8-week (non-nutrition, physical activity or mental health) summer curriculum/program

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ohio State University Aetna Foundation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in child BMI z-score Baseline and 8 weeks No
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