Childhood ObesityNCT02908230
Camp NERF: Methods of a Summer Nutrition Ed Rec & Fitness Program to Prevent Unhealthy Weight Gain in Children
A study testing Enhanced Care in people with Childhood Obesity, run by Ohio State University.
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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Enhanced Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Elementary school; USDA Summer Food Service Program open site; and 3) lacking structured programming
Who cannot join
- -
About this study
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
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.
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- Enhanced Care, Standard Care, Active Control
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced CareBehavioural
8-week (nutrition, physical activity, and mental health) summer curriculum/program
Standard CareBehavioural
8-week (nutrition and physical activity) summer curriculum/program
Active ControlBehavioural
8-week (non-nutrition, physical activity or mental health) summer curriculum/program
| Study group | Role | What they receive |
|---|---|---|
| Active Control | Placebo comparator | Active Control: exposure to a non-nutrition, physical activity, or mental health curriculum/program Receives: Behavioral: Active Control |
| Standard Care | Active comparator | Standard Care: exposure to a nutrition and physical activity curriculum/program Receives: Behavioral: Standard Care |
| Enhanced Care | Experimental | Enhanced Care: exposure to a nutrition, physical activity, and mental health curriculum/program Receives: Behavioral: Enhanced Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child BMI z-score
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Aetna Foundation
- Responsible party
- Principal investigator, Carolyn Gunther, Ohio State University
- Investigators
- Carolyn W Gunther, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908230
- Sponsor's protocol ID
- 2014B0197
- Status last verified
- Sep 2016
- First submitted
- 16 Sep 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30819010Hopkins 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.
PubMed 30275966Hopkins 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.
PubMed 27784290
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02908230
- Acronym / sponsor ID
- 2014B0197
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Aetna Foundation
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Control | Placebo comparator | Behavioral: Active ControlActive Control: exposure to a non-nutrition, physical activity, or mental health curriculum/program |
| Standard Care | Active comparator | Behavioral: Standard CareStandard Care: exposure to a nutrition and physical activity curriculum/program |
| Enhanced Care | Experimental | Behavioral: Enhanced CareEnhanced Care: exposure to a nutrition, physical activity, and mental health curriculum/program |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Elementary school; USDA Summer Food Service Program open site; and 3) lacking structured programming
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Care8-week (nutrition, physical activity, and mental health) summer curriculum/program | Behavioural | Enhanced Care |
| Standard Care8-week (nutrition and physical activity) summer curriculum/program | Behavioural | Standard Care |
| Active Control8-week (non-nutrition, physical activity or mental health) summer curriculum/program | Behavioural | Active Control |
Primary outcome
Change in child BMI z-score
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Derived from this study: PubMed 30819010Hopkins 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.
- Derived from this study: PubMed 30275966Hopkins 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.
- Derived from this study: PubMed 27784290Hopkins 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn W Gunther, PhD principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Care in people with Childhood Obesity, run by Ohio State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child BMI z-score (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02908230, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016.