Physical Activity Referrals to the Community (PARC)

November 2, 2021 updated by: University of California, Berkeley

Primary Care Physical Activity Referrals to the Community

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Mission Neighborhood Health Center
      • San Francisco, California, United States, 94124
        • Southeast Health Center
      • San Francisco, California, United States, 94110
        • Healthy Lifestyles, San Francisco General Hospital
      • San Francisco, California, United States, 94134
        • Silver Avenue Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Referral
Physical activity referral
Behavioral: Physical activity referral
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.
No Intervention: Wait-list control
Wait-list controls receive no intervention until after they provide follow-up measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in minutes per day of moderate-to-vigorous physical activity
Time Frame: Baseline and at 8-11 weeks
Assessed via accelerometry
Baseline and at 8-11 weeks
Change in cardiorespiratory fitness
Time Frame: Baseline and at 10-12 weeks
Assessed via 3 minute step test
Baseline and at 10-12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in body mass index
Time Frame: Baseline and at 10-12 weeks
Baseline and at 10-12 weeks
Change in body composition
Time Frame: Baseline and at 10-12 weeks
Baseline and at 10-12 weeks
Change in blood pressure
Time Frame: Baseline and at 10-12 weeks
Baseline and at 10-12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment and participation in a physical activity program
Time Frame: Baseline and at 10-12 weeks
Baseline and at 10-12 weeks
Change in waist circumference
Time Frame: Baseline and at 10-12 weeks
Baseline and at 10-12 weeks
Change in perceptions about physical activity
Time Frame: Baseline and at 10-12 weeks
Assessed via survey
Baseline and at 10-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Berkeley

Investigators

  • Principal Investigator: Kristine A Madsen, MD, MPH, University of California, Berkeley

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-08-5557
  • 035156 (Other Grant/Funding Number: Safeway Foundation)

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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