NCT02044744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 4, 2021

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

January 22, 2014

Last Update Submit

November 2, 2021

Conditions

Keywords

ObesityPediatric ObesityPhysical ActivityPhysical FitnessPrimary Health CareReferral and Consultation

Outcome Measures

Primary Outcomes (2)

  • Change in minutes per day of moderate-to-vigorous physical activity

    Assessed via accelerometry

    Baseline and at 8-11 weeks

  • Change in cardiorespiratory fitness

    Assessed via 3 minute step test

    Baseline and at 10-12 weeks

Secondary Outcomes (3)

  • Change in body mass index

    Baseline and at 10-12 weeks

  • Change in body composition

    Baseline and at 10-12 weeks

  • Change in blood pressure

    Baseline and at 10-12 weeks

Other Outcomes (3)

  • Enrollment and participation in a physical activity program

    Baseline and at 10-12 weeks

  • Change in waist circumference

    Baseline and at 10-12 weeks

  • Change in perceptions about physical activity

    Baseline and at 10-12 weeks

Study Arms (2)

Referral

EXPERIMENTAL

Physical activity referral

Behavioral: Physical activity referral

Wait-list control

NO INTERVENTION

Wait-list controls receive no intervention until after they provide follow-up measurements.

Interventions

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.

Referral

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Medical conditions that preclude participation in physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Healthy Lifestyles, San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Mission Neighborhood Health Center

San Francisco, California, 94110, United States

Location

Southeast Health Center

San Francisco, California, 94124, United States

Location

Silver Avenue Health Center

San Francisco, California, 94134, United States

Location

MeSH Terms

Conditions

OverweightObesityPediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Kristine A Madsen, MD, MPH

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 4, 2021

Record last verified: 2021-11

Locations