Child ObesityPhase 4NCT07868471
Community Active and Healthy Families Pragmatic Trial
A Phase 4 study testing Community Active and Healthy Families Intensive Health Behavior and Lifestyle Treatment in people with Child Obesity, run by University of Colorado, Denver.
Trial summary
This is a randomized pragmatic trial of the Community-AHF intervention to evaluate its effectiveness at decreasing body mass index in 5-12 year old children. Read more about this study
- Who is it for?
- Ages 5 to 99 years
- Conditions the study is for
- Child Obesity
- What is being tested?
- Community Active and Healthy Families Intensive Health Behavior and Lifestyle Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2028to 30 Jun 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 5-12 AND
- BMI > 85th%tile for age and sex AND
- No medical contraindication to diet modification or engaging in physical activity.
- • For parent participants
- Self-identifies as Latino/Hispanic AND
- Self-identifies as foreign-born AND
Show all 9Show fewer
- Self-identifies as Spanish-speaking AND
- Age ≥ 18 years AND
- No medical contraindication to diet modification or engaging in physical activity.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Community Active and Healthy Families: Promoting Healthy Behaviors and Preventing Chronic Disease
This is a randomized pragmatic trial of the Community-AHF intervention to evaluate its effectiveness at decreasing body mass index in 5-12 year old children.
- Conditions
- Child Obesity
- Being tested
- Community Active and Healthy Families Intensive Health Behavior and Lifestyle Treatment
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Active and Healthy Families Intensive Health Behavior and Lifestyle TreatmentBehavioural
Intensive Health Behavior and Lifestyle Treatment that is community-based and designed for Latino families with children with overweight and obesity
| Study group | Role | What they receive |
|---|---|---|
| Wait-list control | No intervention | Not described |
| Community Active and Healthy Families | Experimental | Not described Receives: Behavioral: Community Active and Healthy Families Intensive Health Behavior and Lifestyle Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in %BMIp95-Primary
Change in %BMIp95 from baseline to 4 months
Measured: Baseline-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Jan 2028 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868471
- Sponsor's protocol ID
- 26-2238
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
DeCamp LR, Valdez-Vormezeele J, Molino E, Musci R, Vuillier J, Delgado Hernandez M, Marroquin Miranda MY, Caicedo IP, Garcia-Hernandez S, Huebschmann AG, Fort MP, Thompson DA, Perrin E, Polk S. Mixed Methods Evaluation of a Community-Based Weight Management Program for Latino Children. Am J Health Promot. 2026 Jun 1:8901171261454826. doi: 10.1177/08901171261454826. Online ahead of print.
PubMed 42224506
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Active and Healthy Families: Promoting Healthy Behaviors and Preventing Chronic Disease
- ClinicalTrials.gov ID
- NCT07868471
- Acronym / sponsor ID
- 26-2238
- Conditions
- Child Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jan 2028 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 9 Oct 2026 (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.
This is a randomized pragmatic trial of the Community-AHF intervention to evaluate its effectiveness at decreasing body mass index in 5-12 year old children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-list control | No intervention | – |
| Community Active and Healthy Families | Experimental | Behavioral: Community Active and Healthy Families Intensive Health Behavior and Lifestyle Treatment |
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age 5-12 AND
- BMI > 85th%tile for age and sex AND
- No medical contraindication to diet modification or engaging in physical activity.
- Self-identifies as Latino/Hispanic AND
- Self-identifies as foreign-born AND
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Community Active and Healthy Families Intensive Health Behavior and Lifestyle TreatmentIntensive Health Behavior and Lifestyle Treatment that is community-based and designed for Latino families with children with overweight and obesity | Behavioural | Community Active and Healthy Families |
Primary outcome
Change in %BMIp95-Primary
Time frame: Baseline-4 months
Change in %BMIp95 from baseline to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 42224506DeCamp LR, Valdez-Vormezeele J, Molino E, Musci R, Vuillier J, Delgado Hernandez M, Marroquin Miranda MY, Caicedo IP, Garcia-Hernandez S, Huebschmann AG, Fort MP, Thompson DA, Perrin E, Polk S. Mixed Methods Evaluation of a Community-Based Weight Management Program for Latino Children. Am J Health Promot. 2026 Jun 1:8901171261454826. doi: 10.1177/08901171261454826. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Community Active and Healthy Families Intensive Health Behavior and Lifestyle Treatment in people with Child Obesity, run by University of Colorado, Denver.
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 9 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: opening soon, as of the sponsor's last update on 9 Oct 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa DeCamp, MD, MSPH (3037246499, lisa.decamp@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in %BMIp95-Primary (time frame: Baseline-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07868471, which also lists 1 linked publication.
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 9 Oct 2026.