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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03189979
Other study ID # 14-003639
Secondary ID UL1TR000135
Status Completed
Phase N/A
First received June 15, 2017
Last updated June 15, 2017
Start date October 2015
Est. completion date May 2016

Study information

Verified date June 2017
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 8 Years to 17 Years
Eligibility Inclusion Criteria:

- Active Boys & Girls Club participation, which was defined as expected Club attendance at least twice weekly.

Exclusion Criteria:

- None

Study Design


Intervention

Behavioral:
Physical activity and healthy eating intervention
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.

Locations

Country Name City State
United States Boys & Girls Club of Rochester, MN Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). baseline, 6 months
Primary 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). baseline, 6 months
Secondary 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). baseline, 6 months
Secondary 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. baseline, 6 months
Secondary 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. baseline, 6 months
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