Community Active and Healthy Families

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Behavioral: Community Active and Healthy Families


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pre/Post
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community-AHF<br>Participants in this arm will receive the Community Active and Healthy Families Intervention | Behavioral: Community Active and Healthy Families<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Child Diet | 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). | Baseline,4 months | 
| Change in 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) | Baseline, 4months | 
| Change in Parenting Self-Efficacy | Change in 4 questions related to self efficacy Range10-60, Higher scores indicate a better outcome (more parenting self efficacy) | Baseline, 4 months | 
| Change in Parent Promotion of Physical Activity/Healthy Eating | selected questions from the School Physical Activity and Nutrition Project | Baseline, 4 months | 
| Change in Obesogenic Food Availability in the Home | 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) | Baseline,4 months | 
| Change in 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) | Baseline, 4 months |