Community Active and Healthy Families

NCT04414553 | Completed Results DMC

• 1 other identifier: 20-1337
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

To address childhood overweight disparities among Latino children in immigrant families a pilot trial of a community-based obesity treatment program, Community Active and Healthy Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant families using pre/post design will be conducted. The hypothesis is that children participating in Community-AHF will demonstrate a reduction in child body mass index as measured by %BMIp95 (primary outcome) and improved diet physical activity behaviors (secondary outcomes) at intervention completion compared with pre-intervention

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (2)

• %BMIp95

  Age- and sex-specific BMI expressed as percent of the 95th percentile. Child Body Mass Index is calculated from child height and weight measurement.

  4 months

• BMI Category

  This measure examines BMI category of overweight, obesity, severe obesity pre/post program

  4 months

Secondary Outcomes (3)

• Child Physical Activity

  4months

• Parenting Self-Efficacy

  4 months

• Parent Perceived Stress

  4 months

Study Arms (1)

Community-AHF

EXPERIMENTAL

Participants in this arm will receive the Community Active and Healthy Families Intervention

Behavioral: Community Active and Healthy Families

Interventions

Community Active and Healthy Families BEHAVIORAL

Community-AHF will consist of eight, semimonthly 2-hour group appointments. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change. Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes.

Community-AHF

Eligibility Criteria

• Age: 5 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Child age 5-12 years with Parent/Caregiver age of 18 or more years
• Child BMI \>/= 85th percentile for age
• Parent is foreign-born, self identifies as Latino/Hispanic and speaks Spanish
• Parental commitment to participate in a 4-month intervention

You may not qualify if:

• Child health condition that prevents diet modification or engaging in physical activity
• Child BMI \>40kg/m2

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Johns Hopkins University: collaborator

Study Sites (2)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This is a pilot study which is not intended to evaluate effectiveness. In addition the study had a 74% completion rate. Missing follow up data may bias the results.

Results Point of Contact

• Title: Lisa Ross DeCamp
• Organization: University of Colorado

lisa.decamp@cuanschutz.edu

3037246499

Study Officials

• Lisa R DeCamp, MD, MSPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre/Post

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 4, 2020
• Study Start: March 13, 2023
• Primary Completion: September 23, 2023
• Study Completion: November 3, 2023
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)