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, 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 78

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 & 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
%BMIp95	4 months	Age- and sex-specific BMI expressed as percent of the 95th percentile. Child Body Mass Index is calculated from child height and weight measurement.
BMI Category	4 months	This measure examines BMI category of overweight, obesity, severe obesity pre/post program

Secondary Outcome Measures

Name	Time	Method
Child Physical Activity	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)
Parenting Self-Efficacy	4 months	4 questions related to self efficacy Range 5-25, Higher scores indicate a better outcome (more parenting self efficacy)
Parent Perceived Stress	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)