Clinical trial NCT04414553: Community Active and Healthy Families
Official title: Community Active and Healthy Families: Family-Centered Obesity Treatment for Latino Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2020-06-04
Enrollment: 78
Sex: ALL
Minimum age (years): 5
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre/Post
Primary purpose: TREATMENT

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, 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.

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

Primary outcomes:
measure: %BMIp95
timeFrame: 4 months
measure: BMI Category
timeFrame: 4 months
Secondary outcomes:
measure: Child Physical Activity
timeFrame: 4months
measure: Parenting Self-Efficacy
timeFrame: 4 months
measure: Parent Perceived Stress
timeFrame: 4 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: University of Colorado, Denver
name: Lisa R DeCamp, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: