Club Fit: Physical Activity and Healthy Eating at an After School Program
Primary Purpose
Childhood Obesity, Physical Activity, Dietary Habits
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity and healthy eating intervention
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring community based participatory research, Childhood obesity
Eligibility Criteria
Inclusion Criteria:
- Active Boys & Girls Club participation, which was defined as expected Club attendance at least twice weekly.
Exclusion Criteria:
- None
Sites / Locations
- Boys & Girls Club of Rochester, MN
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Club Fit
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in self-efficacy
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).
Change in motivation
Motivation for physical activity was scored on a 10-point Likert scale from 1 (not at all motivated) to 10 (extremely motivated).
Secondary Outcome Measures
Change in body mass index
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).
Change in physical activity
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.
Change in dietary quality
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03189979
Brief Title
Club Fit: Physical Activity and Healthy Eating at an After School Program
Official Title
Club Fit: Pilot Testing of a Physical Activity and Healthy Eating Intervention at a Boys & Girls Club After School Program
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Physical Activity, Dietary Habits
Keywords
community based participatory research, Childhood obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Club Fit
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity and healthy eating intervention
Other Intervention Name(s)
Club Fit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in self-efficacy
Description
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).
Time Frame
baseline, 6 months
Title
Change in motivation
Description
Motivation for physical activity was scored on a 10-point Likert scale from 1 (not at all motivated) to 10 (extremely motivated).
Time Frame
baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in body mass index
Description
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).
Time Frame
baseline, 6 months
Title
Change in physical activity
Description
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.
Time Frame
baseline, 6 months
Title
Change in dietary quality
Description
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.
Time Frame
baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Active Boys & Girls Club participation, which was defined as expected Club attendance at least twice weekly.
Exclusion Criteria:
- None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark L Wieland, MD, MPH
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boys & Girls Club of Rochester, MN
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.
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Club Fit: Physical Activity and Healthy Eating at an After School Program
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