Obesity, Childhood
Conditions
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.
Interventions
BEHAVIORALCommunity 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.
Sponsors
Johns Hopkins University
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pre/Post
Eligibility
Sex/Gender
ALL
Age
5 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| %BMIp95 | 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. |
| BMI Category | 4 months | This measure examines BMI category of overweight, obesity, severe obesity pre/post program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Physical Activity | 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) |
| Parenting Self-Efficacy | 4 months | 4 questions related to self efficacy Range 5-25, Higher scores indicate a better outcome (more parenting self efficacy) |
| Parent Perceived Stress | 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) |
Countries
United States
Participant flow
Recruitment details
Participating families were recruited via referral from their primary care provider at academic-based general pediatrics clinics (both sites) or community-based recruitment from among participants in programming at a Latino immigrant-serving family resource center and at nearby elementary schools. (Colorado only). Recruitment occurred between Jan-March 2023.
Pre-assignment details
This was a single arm study where all participants who enrolled were assigned to complete the study intervention.
Participants by arm
| Arm | Count |
|---|---|
| Community-AHF Participants in this arm will receive the Community Active and Healthy Families Intervention
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. | 78 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 20 |
Baseline characteristics
| Characteristic | Community-AHF |
|---|---|
| Age, Categorical <=18 years | 39 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age, Continuous Child Age | 10.1 years STANDARD_DEVIATION 2.2 |
| Age, Continuous Parent Age | 39.6 years STANDARD_DEVIATION 6.2 |
| BMI Category Obese (BMI 95-99%tile) | 2 Participants |
| BMI Category Overweight (BMI 85-94%tile) | 1 Participants |
| BMI Category Severe obesity (BMI >99%tile) | 36 Participants |
| Child Physical Activity High Health Risk (0-1 times/week) | 23 participants |
| Child Physical Activity Low Health Risk (6-7 days/week) | 5 participants |
| Child Physical Activity Medical Contraindication | 0 participants |
| Child Physical Activity Medium Health Risk (3-5 days/week) | 11 participants |
| Parent Perceived Stress | 18.10 units on a scale STANDARD_DEVIATION 20.52 |
| Parent Self Efficacy | 21.00 units on a scale STANDARD_DEVIATION 1.87 |
| Pre-program %BMIp95, mean (SD) | 125.35 percent STANDARD_DEVIATION 23.11 |
| Race/Ethnicity, Customized Latino Ethnicity of any race | 78 Participants |
| Region of Enrollment United States | 78 participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 78 |
| other Total, other adverse events | 0 / 78 |
| serious Total, serious adverse events | 0 / 78 |
Outcome results
Primary
BMI Category
This measure examines BMI category of overweight, obesity, severe obesity pre/post program
Time frame: 4 months
Population: Children with complete pre/post data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Community-AHF | BMI Category | Overweight (BMI 85-94%tile) | 0 Participants |
| Community-AHF | BMI Category | Obese (BMI 95-99%tile) | 3 Participants |
| Community-AHF | BMI Category | Severe obesity (BMI >99%tile) | 26 Participants |
p-value: 0.35Chi-squared
Primary
%BMIp95
Age- and sex-specific BMI expressed as percent of the 95th percentile. Child Body Mass Index is calculated from child height and weight measurement.
Time frame: 4 months
Population: Children who had both pre/post program data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community-AHF | %BMIp95 | 122.35 percent of the 95th percentile of BMI | Standard Deviation 15.95 |
Comparison: This compares pre/post data.p-value: 0.29t-test, 2 sided
Secondary
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)
Time frame: 4months
Population: Participants with complete pre/post data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Community-AHF | Child Physical Activity | Medical Contraindication | 1 Participants |
| Community-AHF | Child Physical Activity | Low Health Risk (6-7 days/week) | 13 Participants |
| Community-AHF | Child Physical Activity | Medium Health Risk (3-5 days/week) | 5 Participants |
| Community-AHF | Child Physical Activity | Low Health Risk (0-1 days/week) | 10 Participants |
p-value: 0.21Chi-squared
Secondary
Parenting Self-Efficacy
4 questions related to self efficacy Range 5-25, Higher scores indicate a better outcome (more parenting self efficacy)
Time frame: 4 months
Population: Participants with complete pre/post data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community-AHF | Parenting Self-Efficacy | 20.14 units on a scale | Standard Deviation 1.27 |
p-value: 0.018t-test, 2 sided
Secondary
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)
Time frame: 4 months
Population: Participants with complete pre/post data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community-AHF | Parent Perceived Stress | 20.52 units on a scale | Standard Deviation 6.29 |
p-value: 0.062t-test, 2 sided