- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03189979
Club Fit: Physical Activity and Healthy Eating at an After School Program
Club Fit: Pilot Testing of a Physical Activity and Healthy Eating Intervention at a Boys & Girls Club After School Program
Background: Youth from low-income and minority families are disproportionately affected by obesity and its complications. This study presented pilot work to develop and implement a multi-component physical activity and healthy eating intervention at a Boys & Girls Club (BGC) after school program.
Methods: Using a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework. Components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. Preliminary intervention efficacy was assessed through a single group, pre-post study design with measured collected at baseline and 6 months.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Boys & Girls Club of Rochester, MN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Active Boys & Girls Club participation, which was defined as expected Club attendance at least twice weekly.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Club Fit
Intervention includes exposure to physical activity and healthy eating intervention policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign.
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Using a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework.
Components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self-efficacy
Time Frame: baseline, 6 months
|
Self-efficacy was assessed with a survey adapted from instruments developed for the Patient-centered Assessment and Counseling for Exercise plus Nutrition program for low-income, ethnically diverse adolescents.
It was scored on a 10-point Likert scale from 1 (not at all confident) to 10 (extremely confident).
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baseline, 6 months
|
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Change in motivation
Time Frame: baseline, 6 months
|
Motivation for physical activity was scored on a 10-point Likert scale from 1 (not at all motivated) to 10 (extremely motivated).
|
baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in body mass index
Time Frame: baseline, 6 months
|
For body mass index (BMI), weight was measured to the nearest 0.1 kg using a single scale.
Height was measured to the nearest 0.1 cm using a stadiometer.
BMI was calculated as weight (kg)/height squared (m2).
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baseline, 6 months
|
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Change in physical activity
Time Frame: baseline, 6 months
|
The Kinetic Activity Monitor accelerometer was used for objective physical activity assessment.
Participants were asked to wear the accelerometer at their waist during waking hours for 10 consecutive days.
The accelerometer was activated and data collected without providing feedback to participants.
A valid assessment required 5 days of wear for at least 10 hours a day.
Data output included sedentary time and time spent performing mild, moderate, and vigorous physical activities.
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baseline, 6 months
|
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Change in dietary quality
Time Frame: baseline, 6 months
|
Dietary assessment was performed with the Beverage and Snack Questionnaire 2. The instrument was adapted to include nine items (on a 7-point Likert scale) that addressed consumption of fruits, vegetables, and sugar sweetened beverages.
The Likert scale ranged from "never or less than 1 per week" to "4+ per day."
The greater number of fruits and vegetables, and fewer number of sugar sweetened beverages were considered a positive change in dietary quality.
|
baseline, 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark L Wieland, MD, MPH, Mayo Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-003639
- UL1TR000135 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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