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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01HD100458-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| University of North Carolina, Chapel Hill | OTHER |
| Vanderbilt University | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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One-size-fits-all approaches have failed to demonstrate sustained effects on childhood obesity, especially among low-income minority families, who experience constantly changing barriers to engaging in health behavior. Addressing obesity in these populations requires intervening in early childhood and situating interventions in the context of families and communities. Developing personalized childhood obesity prevention interventions with sustained effectiveness that support families in health behaviors despite dynamic barriers could address chronic disease risk and health disparities in low-income and minority communities.
Despite the recognition of health disparities in obesity, behavioral interventions among low-income and minority populations have consistently met with limited success. This is partially explained by social determinants of health. Constantly changing barriers at the household and community levels impede consistent engagement in healthy behaviors. The current proposal tests a novel, culturally-tailored and multi-level intervention designed to teach families to overcome dynamic barriers as the logical next step to address obesity among low-income Latino families. It is based on the premise that by implementing a personalized multi-level intervention that simultaneously addresses healthy weight for parents and children, we will improve body mass index (BMI) among Latino parent-child pairs.
COACH (COmpetency-Based Approaches to Community Health) implements a personally tailored approach, equipping families to engage in health behaviors despite dynamic barriers. COACH is a multi-level intervention targeting 1) the individual child through developmentally appropriate health behavior curriculum, 2) the family by addressing parent weight loss directly and engaging parents as agents of change for their children, and 3) the community by building capacity of Parks and Rec centers to offer parent-child programming. Using novel multi-component assessments throughout the study, the intervention identifies individual, family, and community barriers to healthy behaviors and delivers structured yet personalized intervention content in 7 domains: fruits/vegetables, snacks, sugary drinks, physical activity, sleep, media use, and parenting.
Building on a successful pilot, this proposal will implement a randomized controlled trial to test the effectiveness of COACH compared to an attention-matched school-readiness control group. We will enroll 300 parent-child pairs from Latino communities in Nashville, TN.
The goals of COACH are to 1) implement a novel personalized behavioral intervention, 2) test a two-generation solution to obesity, 3) address health disparities by reducing obesity among Latino families, and 4) develop a scalable and widely accessible approach to behavioral obesity interventions by delivering them in Parks and Rec centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COACH Intervention | Experimental | COACH is a multi-level intervention, consisting of 1) developmentally appropriate health curriculum for 4-6 year old children; 2) family-based content that both targets parent weight loss and leverages a shared parent-child experience to improve family health behaviors; 3) community-level intervention to improve access and quality of family-based programming at local Parks and Rec centers. |
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| Educational Control | Active Comparator | The control arm will consist of a school readiness intervention developed by education and literacy experts on our team and implemented at local libraries. It will include 1) child lessons from Puente de Cuentos, a systematic, language-based curriculum focused on dual language storytelling (narrative language), and 2) parent sessions designed to improve parents' knowledge and skills related to improving children's language production and storytelling skills, to ultimately support school readiness. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COACH | Behavioral | Multi-Level Behavioral Intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Child Body Mass Index | Measured prospectively and calculated from child weight/height measures | 24-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Body Mass Index | Measured prospectively and calculated from parent weight/height measures | 24-month follow-up |
| Child Obesity | Percent of children with BMI ≥95th percentile on standardized CDC growth curves |
| Measure | Description | Time Frame |
|---|---|---|
| Child Diet | Parent reported diet quality based on survey measures | 24-month follow-up |
| Parent Diet | Self-report diet quality based on survey measures |
Inclusion Criteria:
Child exclusion criteria:
Caregiver exclusion criteria include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
We will plan to upload a de-identified dataset to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) database (this upload also includes study protocols).
In accordance with NIH policy, we will make these data available no later than 3 years after the end of the trial (final patient follow-up) or 2 years after the main paper of the trial has been published, whichever comes first.
Determined by NIH DASH website
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| NIH |
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| School Readiness Intervention |
| Behavioral |
Multi-Level Language and School Readiness Intervention (Control Group) |
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| 24-month follow-up |
| Child Overweight | Percent of children with BMI percentile ≥85th but less than <95th percentile on standardized CDC growth curves | 24-month follow-up |
| Child Body Mass Index Percentage of the 95th Percentile | Child BMI percentage of the 95th percentile on standardized CDC growth curves | 24-month follow-up |
| Child Body Mass Index z-Scores | Child BMI z-scores on standardized CDC growth reference charts | 24-month follow-up |
| 24-month follow-up |
| Parent Physical Activity | Parent reported physical activity for themselves based on survey measures | 24-month follow-up |
| Child Media Use | Parent reported media use by child based on survey measures | 24-month follow-up |
| Child Sleep | Parent reported sleep times based on survey measures | 24-month follow-up |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |