Physical Activity Referrals to the Community (PARC)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by University of California, Berkeley
Sponsor:
Information provided by (Responsible Party):
University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT02044744
First received: January 22, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: Physical activity referral

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Care Physical Activity Referrals to the Community

Resource links provided by NLM:


Further study details as provided by University of California, Berkeley:

Primary Outcome Measures:
  • Change in minutes per day of moderate-to-vigorous physical activity [ Time Frame: Baseline and at 8-11 weeks ] [ Designated as safety issue: No ]
    Assessed via accelerometry

  • Change in cardiorespiratory fitness [ Time Frame: Baseline and at 10-12 weeks ] [ Designated as safety issue: No ]
    Assessed via 3 minute step test


Secondary Outcome Measures:
  • Change in body mass index [ Time Frame: Baseline and at 10-12 weeks ] [ Designated as safety issue: No ]
  • Change in body composition [ Time Frame: Baseline and at 10-12 weeks ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: Baseline and at 10-12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Enrollment and participation in a physical activity program [ Time Frame: Baseline and at 10-12 weeks ] [ Designated as safety issue: No ]
  • Change in waist circumference [ Time Frame: Baseline and at 10-12 weeks ] [ Designated as safety issue: No ]
  • Change in perceptions about physical activity [ Time Frame: Baseline and at 10-12 weeks ] [ Designated as safety issue: No ]
    Assessed via survey


Estimated Enrollment: 76
Study Start Date: February 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044744

Contacts
Contact: Jennifer Falbe, ScD, MPH 510-642-4861 jfalbe@berkeley.edu

Locations
United States, California
Healthy Lifestyles, San Francisco General Hospital Not yet recruiting
San Francisco, California, United States, 94110
Contact: Amy Becky, MD    415-206-8000    BeckA@peds.ucsf.edu   
Mission Neighborhood Health Center Not yet recruiting
San Francisco, California, United States, 94110
Contact: Jaime Ruiz, MD    415-552-1013    jaimeruiz@mnhc.org   
Silver Avenue Health Center Not yet recruiting
San Francisco, California, United States, 94134
Contact: Jamal Harris, MD    415-657-1700    HarrisJ@peds.ucsf.edu   
Southeast Health Center Not yet recruiting
San Francisco, California, United States, 94124
Contact: Jamal Harris, MD    415-671-7000    HarrisJ@peds.ucsf.edu   
Sponsors and Collaborators
University of California, Berkeley
Investigators
Principal Investigator: Kristine A Madsen, MD, MPH University of California, Berkeley
  More Information

No publications provided

Responsible Party: University of California, Berkeley
ClinicalTrials.gov Identifier: NCT02044744     History of Changes
Other Study ID Numbers: 2013-08-5557, 035156
Study First Received: January 22, 2014
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Berkeley:
Obesity
Pediatric Obesity
Physical Activity
Physical Fitness
Primary Health Care
Referral and Consultation

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014