OverweightAHFNCT02044705
Impact of Active and Healthy Families
A study testing Active and Healthy Families in people with Overweight and Obesity, run by University of California, Berkeley at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the impact of the 10-week Active and Healthy Families (AHF) intervention on body mass index (BMI) in Latino youth aged 5-12 years. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Active and Healthy Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to May 2014
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 5-12 years
- Body mass index greater than or equal to the 85th percentile for age and sex
- Patients seen at Contra Costa County clinics participating in Active and Healthy Families
- Spanish speaking
- Parent of participant
Who cannot join
- Previous participation in Active and Healthy Families
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pittsburg Health Center
Pittsburg, California, 94565
West County Health Center
San Pablo, California, 94806
About this study
Official title: Impact of Active and Healthy Families (Familias Activas y Saludables): A Family-Based Group Medical Appointment Model for Childhood Obesity in Federally Qualified Health Centers
The purpose of this study is to evaluate the impact of the 10-week Active and Healthy Families (AHF) intervention on body mass index (BMI) in Latino youth aged 5-12 years.
- Conditions
- Overweight, Obesity
- Being tested
- Active and Healthy Families
- Keywords
- Primary Health Care, Pediatrics, Obesity, Overweight, Clinical trial, Hispanic Americans, Family, Body mass index
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active and Healthy FamiliesBehavioural
Pediatric obesity intervention delivered through five bi-weekly Active and Healthy Families family-based group medical appointments (i.e., sessions).
| Study group | Role | What they receive |
|---|---|---|
| Family group sessions | Experimental | Active and Healthy Families Receives: Behavioral: Active and Healthy Families |
| Wait-list control | No intervention | Controls may participate in Active and Healthy Families after the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in body mass index (BMI)
Change from baseline are assessed from measured height and weight
Measured: Baseline and at week 10
Secondary outcomes (4)
Change from baseline in blood glucose
Measured: Baseline and week 10
Changes from baseline in fasting lipids
Measured: Baseline and week 10
Change from baseline in insulin resistance
Measured: Baseline and week 10
Change from baseline in blood pressure
Measured: Baseline and week 10
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 startSep 2012
- Primary completionMay 2013
- Study completionMay 2014
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 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, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044705
- Sponsor's protocol ID
- 2012-07-4508 A
- Other IDs
- 033728
- Acronym
- AHF
- Status last verified
- Apr 2015
- First submitted
- 22 Jan 2014
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Active and Healthy Families (Familias Activas y Saludables): A Family-Based Group Medical Appointment Model for Childhood Obesity in Federally Qualified Health Centers
- ClinicalTrials.gov ID
- NCT02044705
- Acronym / sponsor ID
- AHF / 2012-07-4508 A
- Conditions
- Overweight, Obesity
- Keywords
- Primary Health Care, Pediatrics, Obesity, Overweight, Clinical trial, Hispanic Americans, Family, Body mass index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2014 (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 evaluate the impact of the 10-week Active and Healthy Families (AHF) intervention on body mass index (BMI) in Latino youth aged 5-12 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family group sessions | Experimental | Behavioral: Active and Healthy FamiliesActive and Healthy Families |
| Wait-list control | No intervention | –Controls may participate in Active and Healthy Families after the study |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 5-12 years
- Body mass index greater than or equal to the 85th percentile for age and sex
- Patients seen at Contra Costa County clinics participating in Active and Healthy Families
- Spanish speaking
- Parent of participant
Key exclusion criteria (1 listed)
- Previous participation in Active and Healthy Families
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 |
|---|---|---|
| Active and Healthy FamiliesPediatric obesity intervention delivered through five bi-weekly Active and Healthy Families family-based group medical appointments (i.e., sessions). | Behavioural | Family group sessions |
Primary outcome
Changes from baseline in body mass index (BMI)
Time frame: Baseline and at week 10
Change from baseline are assessed from measured height and weight
4 secondary outcomes
Change from baseline in blood glucose
Time frame: Baseline and week 10
Changes from baseline in fasting lipids
Time frame: Baseline and week 10
Change from baseline in insulin resistance
Time frame: Baseline and week 10
Change from baseline in blood pressure
Time frame: Baseline and week 10
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 10 Apr 2015.
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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 principal investigator
University of California, Berkeley
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active and Healthy Families in people with Overweight and Obesity, run by University of California, Berkeley at 2 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 5 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 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Changes from baseline in body mass index (BMI) (time frame: Baseline and at week 10). 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 10 Apr 2015.