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
About this trial
This is an interventional prevention trial for Childhood Obesity
Eligibility Criteria
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
NCT ID
NCT02908230
First Posted
September 16, 2016
Last Updated
September 19, 2016
Sponsor
Ohio State University
Collaborators
Aetna Foundation
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
Camp NERF: Methods of a Summer Nutrition Ed Rec & Fitness Program to Prevent Unhealthy Weight Gain in Children
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