Back to resultsPhysical Activity Referrals to the Community (PARC)
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity referral
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Obesity, Pediatric Obesity, Physical Activity, Physical Fitness, Primary Health Care, Referral and Consultation
Eligibility Criteria
Inclusion Criteria:
- Aged 6-18 years
- Body mass index greater than or equal to the 85th percentile for age and sex or greater than or equal to 25 for youth aged 18
- Fluent in English
- Parent of participant must be fluent in either English or Spanish
Exclusion Criteria:
- Medical conditions that preclude participation in physical activity
Sites / Locations
- Healthy Lifestyles, San Francisco General Hospital
- Mission Neighborhood Health Center
- Southeast Health Center
- Silver Avenue Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Referral
Wait-list control
Arm Description
Physical activity referral
Wait-list controls receive no intervention until after they provide follow-up measurements.
Outcomes
Primary Outcome Measures
Change in minutes per day of moderate-to-vigorous physical activity
Assessed via accelerometry
Change in cardiorespiratory fitness
Assessed via 3 minute step test
Secondary Outcome Measures
Change in body mass index
Change in body composition
Change in blood pressure
Full Information
NCT ID
NCT02044744
First Posted
January 22, 2014
Last Updated
November 2, 2021
Sponsor
University of California, Berkeley
1. Study Identification
Unique Protocol Identification Number
NCT02044744
Brief Title
Physical Activity Referrals to the Community
Acronym
PARC
Official Title
Primary Care Physical Activity Referrals to the Community
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the impact of primary care referrals to community physical activity programs for overweight and obese youth aged 6-18 years on objectively measured physical activity and cardiorespiratory fitness, as well as other cardiovascular health indicators. We hypothesize that physical activity referrals will result in higher levels of physical activity and fitness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Obesity, Pediatric Obesity, Physical Activity, Physical Fitness, Primary Health Care, Referral and Consultation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Referral
Arm Type
Experimental
Arm Description
Physical activity referral
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Wait-list controls receive no intervention until after they provide follow-up measurements.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity referral
Intervention Description
Provision of a primary care referral to at least one community-based physical activity program that is a good match for the participant's needs and preferences and patient follow-up on enrollment.
Primary Outcome Measure Information:
Title
Change in minutes per day of moderate-to-vigorous physical activity
Description
Assessed via accelerometry
Time Frame
Baseline and at 8-11 weeks
Title
Change in cardiorespiratory fitness
Description
Assessed via 3 minute step test
Time Frame
Baseline and at 10-12 weeks
Secondary Outcome Measure Information:
Title
Change in body mass index
Time Frame
Baseline and at 10-12 weeks
Title
Change in body composition
Time Frame
Baseline and at 10-12 weeks
Title
Change in blood pressure
Time Frame
Baseline and at 10-12 weeks
Other Pre-specified Outcome Measures:
Title
Enrollment and participation in a physical activity program
Time Frame
Baseline and at 10-12 weeks
Title
Change in waist circumference
Time Frame
Baseline and at 10-12 weeks
Title
Change in perceptions about physical activity
Description
Assessed via survey
Time Frame
Baseline and at 10-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 6-18 years
Body mass index greater than or equal to the 85th percentile for age and sex or greater than or equal to 25 for youth aged 18
Fluent in English
Parent of participant must be fluent in either English or Spanish
Exclusion Criteria:
Medical conditions that preclude participation in physical activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine A Madsen, MD, MPH
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthy Lifestyles, San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Mission Neighborhood Health Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Southeast Health Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94124
Country
United States
Facility Name
Silver Avenue Health Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Physical Activity Referrals to the Community
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