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
About this trial
This is an interventional treatment trial for Obesity, Childhood
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 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
NCT ID
NCT04414553
First Posted
May 20, 2020
Last Updated
January 27, 2023
Sponsor
University of Colorado, Denver
Collaborators
Johns Hopkins University
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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