Community Active and Healthy Families

Obesity, Childhood Clinical Trial

— CommunityAHF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414553
• Other study ID #: 20-1337
• Status: Completed
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: November 3, 2023

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 3, 2023
• Est. primary completion date: September 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Community Active and Healthy Families
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.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Total-log activity counts	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.	Baseline, 4 months,
Other	Change in Total Activity Counts	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.	Baseline, 4 months,
Other	Change in Active-to-sedentary transition probability	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.	Baseline, 4 months,
Primary	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	Baseline, 4 months
Primary	Change in %BMIp95 Trajectory	Child %BMIp95 over time as measured at baseline, 4 months	Baseline, 4 months
Secondary	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).	Baseline,4 months
Secondary	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)	Baseline, 4months
Secondary	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)	Baseline, 4 months
Secondary	Change in Parent Promotion of Physical Activity/Healthy Eating Questions	selected questions from the School Physical Activity and Nutrition Project no established scale but we are planning to create a composite score based on these questions but will need to see the distribution of responses to finalize	Baseline, 4 months
Secondary	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)	Baseline,4 months
Secondary	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)	Baseline, 4 months