OverweightPARCNCT02044744
Physical Activity Referrals to the Community
A study testing Physical activity referral in people with Overweight and Obesity, run by University of California, Berkeley at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Physical activity referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Medical conditions that preclude participation in physical activity
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Healthy Lifestyles, San Francisco General Hospital
San Francisco, California, 94110
Mission Neighborhood Health Center
San Francisco, California, 94110
Southeast Health Center
San Francisco, California, 94124
Silver Avenue Health Center
San Francisco, California, 94134
About this study
Official title: 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.
- Conditions
- Overweight, Obesity
- Being tested
- Physical activity referral
- Keywords
- Obesity, Pediatric Obesity, Physical Activity, Physical Fitness, Primary Health Care, Referral and Consultation
- Medical subject headings
- Overweight, Obesity, Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity referralBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Referral | Experimental | Physical activity referral Receives: Behavioral: Physical activity referral |
| Wait-list control | No intervention | Wait-list controls receive no intervention until after they provide follow-up measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in minutes per day of moderate-to-vigorous physical activity
Assessed via accelerometry
Measured: Baseline and at 8-11 weeks
Change in cardiorespiratory fitness
Assessed via 3 minute step test
Measured: Baseline and at 10-12 weeks
Secondary outcomes (3)
Change in body mass index
Measured: Baseline and at 10-12 weeks
Change in body composition
Measured: Baseline and at 10-12 weeks
Change in blood pressure
Measured: Baseline and at 10-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristine A Madsen, MD, MPH, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044744
- Sponsor's protocol ID
- 2013-08-5557
- Other IDs
- 035156
- Acronym
- PARC
- Status last verified
- Nov 2021
- First submitted
- 22 Jan 2014
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Physical Activity Referrals to the Community
- ClinicalTrials.gov ID
- NCT02044744
- Acronym / sponsor ID
- PARC / 2013-08-5557
- Conditions
- Overweight, Obesity
- Keywords
- Obesity, Pediatric Obesity, Physical Activity, Physical Fitness, Primary Health Care, Referral and Consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referral | Experimental | Behavioral: Physical activity referralPhysical activity referral |
| Wait-list control | No intervention | –Wait-list controls receive no intervention until after they provide follow-up measurements. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Medical conditions that preclude participation in physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity referralProvision 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. | Behavioural | Referral |
Primary outcome
Change in minutes per day of moderate-to-vigorous physical activity
Time frame: Baseline and at 8-11 weeks
Assessed via accelerometry
Change in cardiorespiratory fitness
Time frame: Baseline and at 10-12 weeks
Assessed via 3 minute step test
3 secondary outcomes
Change in body mass index
Time frame: Baseline and at 10-12 weeks
Change in body composition
Time frame: Baseline and at 10-12 weeks
Change in blood pressure
Time frame: Baseline and at 10-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine A Madsen, MD, MPH principal investigator
University of California, Berkeley
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity referral in people with Overweight and Obesity, run by University of California, Berkeley at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in minutes per day of moderate-to-vigorous physical activity (time frame: Baseline and at 8-11 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.