Community Active and Healthy Families (CommunityAHF)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Obesity, Childhood

Treatments: Behavioral: Community Active and Healthy Families

Study type: Interventional

Funder types: Other

Identifiers

NCT04414553

20-1337

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 5 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Community-AHF

Experimental group

Description:

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

Treatment:

Behavioral: Community Active and Healthy Families