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Completed

NCT Number: NCT04414553

Community Active and Healthy Families

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

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Key information

Age range

5 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community Active and Healthy Families

Behavioral

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.

Primary outcomes

  1. %BMIp95

    Time frame: 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.

  2. BMI Category

    Time frame: 4 months

    This measure examines BMI category of overweight, obesity, severe obesity pre/post program

Secondary outcomes

  1. Child Physical Activity

    Time frame: 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)

  2. Parenting Self-Efficacy

    Time frame: 4 months

    4 questions related to self efficacy Range 5-25, Higher scores indicate a better outcome (more parenting self efficacy)

  3. Parent Perceived Stress

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Johns Hopkins University

Registry information

Official study title

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

Acronym: CommunityAHF

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2020
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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