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

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced Care
Standard Care
Active Control
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria (site level):

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

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Experimental

    Arm Label

    Active Control

    Standard Care

    Enhanced Care

    Arm Description

    Active Control: exposure to a non-nutrition, physical activity, or mental health curriculum/program

    Standard Care: exposure to a nutrition and physical activity curriculum/program

    Enhanced Care: exposure to a nutrition, physical activity, and mental health curriculum/program

    Outcomes

    Primary Outcome Measures

    Change in child BMI z-score

    Secondary Outcome Measures

    Full Information

    First Posted
    September 16, 2016
    Last Updated
    September 19, 2016
    Sponsor
    Ohio State University
    Collaborators
    Aetna Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02908230
    Brief Title
    Camp NERF: Methods of a Summer Nutrition Ed Rec & Fitness Program to Prevent Unhealthy Weight Gain in Children
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ohio State University
    Collaborators
    Aetna Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary aims of this research project are to: Evaluate the efficacy of Camp NERF to improve child nutrition, physical activity, mental health, and anthropometric outcomes. 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. Evaluate the efficacy of Camp NERF to improve youth mentor nutrition, physical activity, and anthropometric outcomes.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    87 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Control
    Arm Type
    Placebo Comparator
    Arm Description
    Active Control: exposure to a non-nutrition, physical activity, or mental health curriculum/program
    Arm Title
    Standard Care
    Arm Type
    Active Comparator
    Arm Description
    Standard Care: exposure to a nutrition and physical activity curriculum/program
    Arm Title
    Enhanced Care
    Arm Type
    Experimental
    Arm Description
    Enhanced Care: exposure to a nutrition, physical activity, and mental health curriculum/program
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhanced Care
    Intervention Description
    8-week (nutrition, physical activity, and mental health) summer curriculum/program
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard Care
    Intervention Description
    8-week (nutrition and physical activity) summer curriculum/program
    Intervention Type
    Behavioral
    Intervention Name(s)
    Active Control
    Intervention Description
    8-week (non-nutrition, physical activity or mental health) summer curriculum/program
    Primary Outcome Measure Information:
    Title
    Change in child BMI z-score
    Time Frame
    Baseline and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria (site level): Elementary school; USDA Summer Food Service Program open site; and 3) lacking structured programming Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carolyn W Gunther, PhD
    Organizational Affiliation
    Ohio State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30819010
    Citation
    Hopkins LC, Webster A, Kennel JA, Purtell KM, Gunther C. Youth Mentor Dietary Outcomes and Waist Circumference Improvement: Camp NERF Study Findings. Health Promot Pract. 2020 Nov;21(6):962-971. doi: 10.1177/1524839919833989. Epub 2019 Feb 28.
    Results Reference
    derived
    PubMed Identifier
    30275966
    Citation
    Hopkins LC, Fristad M, Goodway JD, Melnyk B, Eneli I, Holloman C, Kennel JA, Webster A, Sharn AR, Gunther C. Feasibility and acceptability of technology-based caregiver engagement strategies delivered in a summertime childhood obesity prevention intervention: results from an internal pilot of the Camp NERF (Nutrition, Education, Recreation, and Fitness) study. Pilot Feasibility Stud. 2018 Sep 27;4:153. doi: 10.1186/s40814-018-0340-2. eCollection 2018.
    Results Reference
    derived
    PubMed Identifier
    27784290
    Citation
    Hopkins LC, Fristad M, Goodway JD, Eneli I, Holloman C, Kennel JA, Melnyk B, Gunther C. 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. BMC Public Health. 2016 Oct 26;16(1):1122. doi: 10.1186/s12889-016-3765-7.
    Results Reference
    derived

    Learn more about this trial

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