Community Active and Healthy Families (CommunityAHF)

Community Active and Healthy Families: Family-Centered Obesity Treatment for Latino Children

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

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: Community Active and Healthy Families

Detailed Description

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 a pre/post design will be conducted.

As this is a pilot study, the study will not be powered to detect statistically significant differences pre- and post- intervention. The investigators will measure the average change in %BMIp95 between baseline and completion of the Community-AHF active phase. Without a counterfactual (control group) the investigators will not be able assign responsibility to Community-AHF for any observed improvements. Change in %BMIp95 across the study period will provide data to test our hypotheses and will inform statistical power analyses for a subsequent trial. This pre- and post-intervention data is ideal for generating sample size estimates for a larger randomized control trial in the same population.

The investigators will conduct within-individual analyses for each outcome of interest. The investigators will only analyze participants who contribute pre and post measures in order to avoid biases that can occur when analyses are conducted with all available data. For each outcome for which a participant contributes pre and post measurements, the investigators will calculate pre and post means, standard deviations, differences in means and the p-value of the difference. The investigators will conduct preliminary analyses of outcomes according to subgroups defined by rate of attendance at intervention sessions. If adequate data are available, the investigators will explore the possibility of a nonresponse analysis.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Community-AHF; Participants in this arm will receive the Community Active and Healthy Families Intervention

Behavioral: Community Active and Healthy Families; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
%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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Physical Activity	parent-report of the number of days the child is physically active for 60 minutes during a typical week Range 0-7, Higher scores indicate a better outcome (more physical activity)	4months
Parenting Self-Efficacy	4 questions related to self efficacy Range 5-25, Higher scores indicate a better outcome (more parenting self efficacy)	4 months
Parent Perceived Stress	The 10-item Perceived Stress Score measures global perceived stress experienced across the past 30 days. Range: 0-40, lower scores indicate a better outcome (less stress)	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total-log activity counts	This is an accelerometer-derived measure on a subset of participants that characterizes volume of activity. It is calculated by taking the log of activity counts observed for each minute, adding 1, and then calculating an average value per day. The log transformation of total activity counts results in the improved sensitivity to lower volumes of activity. This measure can be helpful for populations that have low levels of activity and is a continuous measure.	Baseline, 4 months,
Change in Total Activity Counts	This is an accelerometer derived measure that characterizes general volume of physical activity. This is the most commonly used measure to understand accelerometer-derived activity during the day and is a continuous measure.	Baseline, 4 months,
Change in Active-to-sedentary transition probability	This is an accelerometer-derived measure that characterizes fragmentation of physical activity and depends on the frequency of transitioning from active to sedentary state. It is a complementary measure to volume of physical activity. This is a bounded measure between 0-1.	Baseline, 4 months,

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Lisa R DeCamp, MD, MSPH, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Actual): September 23, 2023
• Study Completion (Actual): November 3, 2023

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 20-1337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pending further study planning we will make this decision.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No