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Community Active and Healthy Families (CommunityAHF)

Primary Purpose

Obesity, Childhood

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community Active and Healthy Families
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood

Eligibility Criteria

5 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept 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 10-month intervention

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Community-AHF

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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
    Change in %BMIp95 Trajectory
    Child %BMIp95 over time as measured at baseline, 4 months

    Secondary Outcome Measures

    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).
    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)
    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)
    Change in Parent Promotion of Physical Activity/Healthy Eating
    selected questions from the School Physical Activity and Nutrition Project
    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)
    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)

    Full Information

    First Posted
    May 20, 2020
    Last Updated
    January 27, 2023
    Sponsor
    University of Colorado, Denver
    Collaborators
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04414553
    Brief Title
    Community Active and Healthy Families
    Acronym
    CommunityAHF
    Official Title
    Community Active and Healthy Families: Family-Centered Obesity Treatment for Latino Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2023 (Anticipated)
    Primary Completion Date
    April 2025 (Anticipated)
    Study Completion Date
    March 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    Collaborators
    Johns Hopkins University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Childhood

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Pre/Post
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Community-AHF
    Arm Type
    Experimental
    Arm Description
    Participants in this arm will receive the Community Active and Healthy Families Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Community Active and Healthy Families
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change in age- and sex-specific BMI expressed as percent of the 95th percentile (%BMIp95)
    Description
    Child Body Mass Index as calculated from child height and weight measurement to assess change from baseline to 10 month followup
    Time Frame
    Baseline, 4 months
    Title
    Change in %BMIp95 Trajectory
    Description
    Child %BMIp95 over time as measured at baseline, 4 months
    Time Frame
    Baseline, 4 months
    Secondary Outcome Measure Information:
    Title
    Change in Child Diet
    Description
    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).
    Time Frame
    Baseline,4 months
    Title
    Change in Child Physical Activity
    Description
    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)
    Time Frame
    Baseline, 4months
    Title
    Change in Parenting Self-Efficacy
    Description
    Change in 4 questions related to self efficacy Range10-60, Higher scores indicate a better outcome (more parenting self efficacy)
    Time Frame
    Baseline, 4 months
    Title
    Change in Parent Promotion of Physical Activity/Healthy Eating
    Description
    selected questions from the School Physical Activity and Nutrition Project
    Time Frame
    Baseline, 4 months
    Title
    Change in Obesogenic Food Availability in the Home
    Description
    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)
    Time Frame
    Baseline,4 months
    Title
    Change in Parent Perceived Stress
    Description
    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)
    Time Frame
    Baseline, 4 months
    Other Pre-specified Outcome Measures:
    Title
    Change in Total-log activity counts
    Description
    This is an accelerometer-derived measure on a subset of participants that characterizes volume of activity. It is calculated by taking the log of activity counts observed for each minute, adding 1, and then calculating an average value per day. The log transformation of total activity counts results in the improved sensitivity to lower volumes of activity. This measure can be helpful for populations that have low levels of activity and is a continuous measure.
    Time Frame
    Baseline, 4 months,
    Title
    Change in Total Activity Counts
    Description
    This is an accelerometer derived measure that characterizes general volume of physical activity. This is the most commonly used measure to understand accelerometer-derived activity during the day and is a continuous measure.
    Time Frame
    Baseline, 4 months,
    Title
    Change in Active-to-sedentary transition probability
    Description
    This is an accelerometer-derived measure that characterizes fragmentation of physical activity and depends on the frequency of transitioning from active to sedentary state. It is a complementary measure to volume of physical activity. This is a bounded measure between 0-1.
    Time Frame
    Baseline, 4 months,

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lisa R DeCamp, MD, MSPH
    Phone
    13037246499
    Email
    lisa.decamp@cuanschutz.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisa R DeCamp, MD, MSPH
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Pending further study planning we will make this decision.

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    Community Active and Healthy Families

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