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
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
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- 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