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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community-AHF | Experimental | Participants in this arm will receive the Community Active and Healthy Families Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Active and Healthy Families | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| %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. | 4 months |
| BMI Category | This measure examines BMI category of overweight, obesity, severe obesity pre/post program | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4months |
| Parenting Self-Efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa R DeCamp, MD, MSPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States | ||
| Johns Hopkins University |
Pending further study planning we will make this decision.
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This was a single arm study where all participants who enrolled were assigned to complete the study intervention.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The baseline analyses describe the 39 dyads that participate in the Community AHF Pilot.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Children who had both pre/post program data | Posted | Mean | Standard Deviation | percent of the 95th percentile of BMI | 4 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This is a pilot study which is not intended to evaluate effectiveness. In addition the study had a 74% completion rate. Missing follow up data may bias the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Ross DeCamp | University of Colorado | 3037246499 | lisa.decamp@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 13, 2022 | Dec 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Pre/Post
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|
4 questions related to self efficacy Range 5-25, Higher scores indicate a better outcome (more parenting self efficacy)
| 4 months |
| 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) | 4 months |
| Baltimore |
| Maryland |
| 21224 |
| United States |
| Participants |
|
| Age, Continuous | Mean Child and Parent Age as separate categories | The # analyzed per row differs as we are looking at parent and child mean age separately | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pre-program %BMIp95, mean (SD) | Our primary outcome age- and sex-specific BMI expressed as percent of the 95th percentile (%BMIp95) based on Centers for Disease Control's 2000 growth charts. %BMIp95 is recommended in longitudinal studies due to constraints of BMI z-scores among children with severe obesity. | This outcome only applies to the child participant | Mean | Standard Deviation | percent |
|
| BMI Category | Ths describes the category of overweight/obesity where the child measured at baseline | Only children had BMI outcomes measured | Count of Participants | Participants |
|
| Child Physical Activity | # of days per week the child is physically active | This measure of physical activity in the last week applies to the child only | Number | participants |
|
| Parent Self Efficacy | Parent Self-Efficacy for Healthy Weight Promotion | This measure is only for the parents | Mean | Standard Deviation | units on a scale |
|
| Parent Perceived Stress | The measure is a parent self report of stress using the validated Perceived Stress Scale-10 | This is a parent only measure | Mean | Standard Deviation | units on a scale |
|
|
|
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| Primary | BMI Category | This measure examines BMI category of overweight, obesity, severe obesity pre/post program | Children with complete pre/post data | Posted | Count of Participants | Participants | 4 months |
|
|
|
|
| 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) | Participants with complete pre/post data | Posted | Count of Participants | Participants | 4months |
|
|
|
|
| Secondary | Parenting Self-Efficacy | 4 questions related to self efficacy Range 5-25, Higher scores indicate a better outcome (more parenting self efficacy) | Participants with complete pre/post data | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
|
| 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) | Participants with complete pre/post data | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
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|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 0 |
| 78 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Medical Contraindication |
|