NCT07868471

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for phase_4

Timeline
55mo left

Started Jan 2028

Longer than P75 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2028

Expected
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2031

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2032

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

3.5 years

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Child Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in %BMIp95-Primary

    Change in %BMIp95 from baseline to 4 months

    Baseline-4 months

Study Arms (2)

Wait-list control

NO INTERVENTION

Community Active and Healthy Families

EXPERIMENTAL
Behavioral: Community Active and Healthy Families Intensive Health Behavior and Lifestyle Treatment

Interventions

Community Active and Healthy Families Intensive Health Behavior and Lifestyle TreatmentBEHAVIORAL

Intensive Health Behavior and Lifestyle Treatment that is community-based and designed for Latino families with children with overweight and obesity

Community Active and Healthy Families

Eligibility Criteria

Age5 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Self-identifies as Spanish-speaking AND
  • Age ≥ 18 years AND
  • No medical contraindication to diet modification or engaging in physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 42224506BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Lisa DeCamp, MD, MSPH

CONTACT

3037246499lisa.decamp@cuanschutz.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start (Estimated)

January 1, 2028

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

June 30, 2032

Last Updated

October 9, 2026

Record last verified: 2026-10