ObesityNCT04132245
Family-based Outcome Results
A study testing behavioral intervention and Obesity prevention intervention trial in people with Obesity, run by University of Illinois Chicago.
Trial summary
Many obesity related risk factors are strikingly apparent in minority populations. Mexican-American children have the highest rates of overweight. The goals of this study are to: 1) test the acceptability of a 14-week family-based intervention with 3-5 year old children and their parents; 2) Estimate the effectiveness… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- behavioral intervention and Obesity prevention intervention trial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Apr 2011
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- have received an annual physical
- parent or guardian willing to give consent
- parent or guardian willing to provide demographic and anthropometric data and agree to complete food intake and physical activity information for their child
Who cannot join
- requires a specialized diet outside of that served by the Chicago Public Schools
- has a chronic physical or behavioral disorder that requyires participant to be under close emdical psychologicagl supervision and routinely absent from the study
About this study
Official title: Famil-based Obesity Prevention Trial in Latino Families
Many obesity related risk factors are strikingly apparent in minority populations. Mexican-American children have the highest rates of overweight. The goals of this study are to: 1) test the acceptability of a 14-week family-based intervention with 3-5 year old children and their parents; 2) Estimate the effectiveness of a 14-week family-based intervention designed to show smaller changes, on average, in BMI appropriate for growth; 3) estimate the effectiveness of a 14-week family-based intervention designed to produce changes in television viewing, physical activity, fat, fiber, and fruit and vegetable intake in 3-5 year old Latino children and their parents at post-intervention and Year 1 follow-up.
- Conditions
- Obesity
- Being tested
- behavioral intervention, Obesity prevention intervention trial
- Keywords
- childhood obesity, minorities, diet, physical activity, parents
- Medical subject headings
- Obesity, Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral interventionBehavioural
Families were randomized to a 14-week family based obesity prevention intervention or a 14-week general health intervention
Obesity prevention intervention trialBehavioural
Families were randomized to a 14-week obesity prevention intervention or a 14-week general health intervention
| Study group | Role | What they receive |
|---|---|---|
| obesity prevention | Experimental | Families were randomized to an obesity prevention intervention arm or a general health control arm. Receives: Behavioral: Obesity prevention intervention trial |
| behavioral intervention | Experimental | there are two arms in this study. An active intervention arm and a control arm Receives: Behavioral: behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
we measured the change in BMI of the children at baseline and post-intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study startApr 2008
- Primary completionApr 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fitzgibbon, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132245
- Sponsor's protocol ID
- R21CA121423
- Status last verified
- Oct 2019
- First submitted
- 16 May 2016
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Famil-based Obesity Prevention Trial in Latino Families
- ClinicalTrials.gov ID
- NCT04132245
- Acronym / sponsor ID
- R21CA121423
- Conditions
- Obesity
- Keywords
- childhood obesity, minorities, diet, physical activity, parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Oct 2019 (actual)
- 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.
Many obesity related risk factors are strikingly apparent in minority populations. Mexican-American children have the highest rates of overweight. The goals of this study are to: 1) test the acceptability of a 14-week family-based intervention with 3-5 year old children and their parents; 2) Estimate the effectiveness of a 14-week family-based intervention designed to show smaller changes, on average, in BMI appropriate for growth; 3) estimate the effectiveness of a 14-week family-based intervention designed to produce changes in television viewing, physical activity, fat, fiber, and fruit and vegetable intake in 3-5 year old Latino children and their parents at post-intervention and Year 1 follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obesity prevention | Experimental | Behavioral: Obesity prevention intervention trialFamilies were randomized to an obesity prevention intervention arm or a general health control arm. |
| behavioral intervention | Experimental | Behavioral: behavioral interventionthere are two arms in this study. An active intervention arm and a control arm |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- have received an annual physical
- parent or guardian willing to give consent
- parent or guardian willing to provide demographic and anthropometric data and agree to complete food intake and physical activity information for their child
Key exclusion criteria (2 listed)
- requires a specialized diet outside of that served by the Chicago Public Schools
- has a chronic physical or behavioral disorder that requyires participant to be under close emdical psychologicagl supervision and routinely absent from the study
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 |
|---|---|---|
| behavioral interventionFamilies were randomized to a 14-week family based obesity prevention intervention or a 14-week general health intervention | Behavioural | behavioral intervention |
| Obesity prevention intervention trialFamilies were randomized to a 14-week obesity prevention intervention or a 14-week general health intervention | Behavioural | obesity prevention |
Primary outcome
Body mass index
Time frame: 1 year
we measured the change in BMI of the children at baseline and post-intervention
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 18 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral intervention and Obesity prevention intervention trial in people with Obesity, run by University of Illinois Chicago.
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 3 inclusion and 2 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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Body mass index (time frame: 1 year). 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 18 Oct 2019.