Community Active and Healthy Families

Not Applicable

Completed

• Conditions: Obesity, Childhood
• Interventions: Behavioral: Community Active and Healthy Families

• Registration Number: NCT04414553
• Lead Sponsor: University of Colorado, Denver

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

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, we will not be powered to detect statistically significant differences pre- and post- intervention. We will measure the average change in %BMIp95 between baseline and completion of the Community-AHF active phase. Without a counterfactual (control group) we 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.

We will conduct within-individual analyses for each outcome of interest. We 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, we will calculate pre and post means, standard deviations, differences in means and the p-value of the difference. We will conduct preliminary analyses of outcomes according to subgroups defined by rate of attendance at intervention sessions. If adequate data are available, we will explore the possibility of a nonresponse analysis.

Study Timeline

• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-04
• Study Start: 2023-03-10
• Primary Completion: 2023-09-23
• Study Completion: 2023-11-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Community-AHF	Community Active and Healthy Families	Participants in this arm will receive the Community Active and Healthy Families Intervention

Primary Outcome Measures

Name	Time	Method
Change in age- and sex-specific BMI expressed as percent of the 95th percentile (%BMIp95)	Baseline, 4 months	Child Body Mass Index as calculated from child height and weight measurement to assess change from baseline to 10 month followup
Change in %BMIp95 Trajectory	Baseline, 4 months	Child %BMIp95 over time as measured at baseline, 4 months

Secondary Outcome Measures

Name	Time	Method
Change in Parenting Self-Efficacy	Baseline, 4 months	Change in 4 questions related to self efficacy Range10-60, Higher scores indicate a better outcome (more parenting self efficacy)
Change in Parent Promotion of Physical Activity/Healthy Eating Questions	Baseline, 4 months	selected questions from the School Physical Activity and Nutrition Project no established scale but we are planning to create a composite score based on these questions but will need to see the distribution of responses to finalize
Change in Obesogenic Food Availability in the Home	Baseline,4 months	Availability of food in the home that contributes to obesity (high-fat foods, candy, processed meats) determined by home food inventory measure Range: 0-71; lower scores indicate a better outcome (less obesogenic food in the home)
Change in Parent Perceived Stress	Baseline, 4 months	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)
Change in Child Physical Activity	Baseline, 4months	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)
Change in Child Diet	Baseline,4 months	Child diet is measured using the Block Kids Food Screener or selected questions from the School Physical Activity Nutrition Project (only used if Block screener not approved by University Purchasing office as it is licensed). The Block Kids Food Screener is a 41-item food frequency questionnaire developed by NutritionQuest (Berkeley, California, USA).

Trial Locations

Locations (2)

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States