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This study is a family-centered, community-based intervention to prevent and treat childhood obesity among 3-5 year old children from undeserved communities. Half of participants will receive a healthy lifestyle intervention and half of participants will receive a school-readiness intervention.
The complex multi-level determinants of childhood obesity necessitate a personalized approach. One of the main challenges to effective behavior change interventions is the complexity of the systems in which these behaviors are situated. Namely, health behaviors are the result of the confluence of macro-level influences (e.g., the built environment, family, etc.) and micro-level influences (e.g., stress). Furthermore, it is imperative that attempts to support healthy childhood growth consider the foundational contribution of a person's culture to their health behaviors, especially as children from traditionally underserved minorities are often hardest hit by obesity.
This program will test a 15 week behavioral intervention followed by 3 months of coaching calls that uses principles from the learning sciences and health behavior change to help shape healthy behaviors in the context of family. The follow-up of the study will last 1 year. The content of the intervention will focus on health behavior change, including teaching goal-setting and self monitoring skills, as well as parenting strategies.
The primary outcome of interest will be early childhood BMI trajectory over 1 year. Additional measures will include survey data to measure parent and child health behaviors (e.g., diet, physical activity, sleep, media use) that are associated with obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COACH: Healthy Bodies | Experimental | This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months. |
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| COACH: Strong minds | Active Comparator | This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COACH: Healthy Bodies | Behavioral | Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Child Body Mass Index | child BMI trajectory across 12 months; BMI differences over time are estimates from the longitudinal mixed-effects regression model | Baseline, 4 months, 7 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Child Diet: Soda | Parent-reported survey data; Child diet: Soda was measured by a single survey item used in the Feeding Infants and Toddlers Study with higher values representing higher frequency of consumption per day. (citation: Ziegler P, Briefel R, Clusen N, et al. Feeding Infants and Toddlers Study (FITS): Development of the FITS survey in comparison to other dietary survey methods. J Am Diet Assoc 2006;106:S12-S27.) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Heerman, MD MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31381365 | Result | Heerman WJ, Teeters L, Sommer EC, Burgess LE, Escarfuller J, Van Wyk C, Barkin SL, Duhon AA, Cole J, Samuels LR, Singer-Gabella M. Competency-Based Approaches to Community Health: A Randomized Controlled Trial to Reduce Childhood Obesity among Latino Preschool-Aged Children. Child Obes. 2019 Dec;15(8):519-531. doi: 10.1089/chi.2019.0064. Epub 2019 Aug 5. | |
| 36316788 |
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| ID | Title | Description |
|---|---|---|
| FG000 | COACH: Healthy Bodies | This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months. COACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family. |
| FG001 | COACH: Strong Minds | This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy. COACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | COACH: Healthy Bodies | This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months. COACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family. |
| 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 | Change in Child Body Mass Index | child BMI trajectory across 12 months; BMI differences over time are estimates from the longitudinal mixed-effects regression model | Number analyzed differs across each time point as it relates to retention | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 4 months, 7 months, 1 year |
|
Adverse Events were collected throughout the study. We specifically asked about adverse events and serious adverse events at each follow-up time point (4 months, 7 months, 1 year), but always completed follow-up and documentation for any event in between data collection time points.
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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 | COACH: Healthy Bodies | This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months. COACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family. |
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The study was conducted among Latino families; findings should not be generalized to other populations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Heerman, MD MPH | Vanderbilt University Medical Center | 615-322-7080 | bill.heerman@vumc.org |
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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 | May 2, 2017 | Aug 29, 2019 | 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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The investigators and data collectors will be blinded to randomization status. Because this is a behavioral intervention, the participants and interventionists will be unblinded.
| COACH: Strong Minds | Behavioral | School Readiness Intervention focusing on literacy and parent skills |
|
| 4 months |
| Child Physical Activity | Parent-reported survey data | 4 months |
| Parent BMI | 4 months |
| Parent Diet Practices | Self-reported survey data; Parent diet practices were measured by using a summed score of a 4-item questionnaire of eating behaviors, including overeating, unplanned eating, making poor food choices, and emotional eating. Higher scores represent more unhealthy parent dieting practices. Items ranged on a scale from 0-5 and were summed to create the scale which ranged from 0-20. | 4 months |
| Parenting Practices: Engagement | Self-reported survey data; Parenting practices around child physical activity were measured by the Preschooler Physical Activity Parenting Practices (PPAPP) scale which has an engagement subscale. Parenting practices: Engagement was a 15 item subscale of the PPAPP survey with higher scores representing higher parent engagement practices. Items ranged on a scale from 1-5 and were summed to create the subscale which ranged from 15-75. | 4 months |
| Adams LE, Sommer EC, Truesdale KP, Barkin SL, Heerman WJ. Validation of a new scoring approach of a child dietary questionnaire for use in early childhood among low-income, Latino populations. BMC Nutr. 2022 Oct 31;8(1):125. doi: 10.1186/s40795-022-00618-4. |
| BG001 | COACH: Strong Minds | This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy. COACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | COACH: Strong Minds | This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy. COACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills |
|
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| Secondary | Child Diet: Soda | Parent-reported survey data; Child diet: Soda was measured by a single survey item used in the Feeding Infants and Toddlers Study with higher values representing higher frequency of consumption per day. (citation: Ziegler P, Briefel R, Clusen N, et al. Feeding Infants and Toddlers Study (FITS): Development of the FITS survey in comparison to other dietary survey methods. J Am Diet Assoc 2006;106:S12-S27.) | Secondary analysis was based on participants with complete data on the Child Diet: Soda measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI. | Posted | Mean | Standard Deviation | Sodas/day | 4 months |
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| Secondary | Child Physical Activity | Parent-reported survey data | Secondary analysis was based on participants with complete data on the child active days per week measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI. | Posted | Mean | Standard Deviation | Child active days per week | 4 months |
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| Secondary | Parent BMI | Secondary analysis was based on participants with complete data on the Adult BMI measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI. | Posted | Mean | Standard Deviation | kg/m^2 | 4 months |
|
|
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| Secondary | Parent Diet Practices | Self-reported survey data; Parent diet practices were measured by using a summed score of a 4-item questionnaire of eating behaviors, including overeating, unplanned eating, making poor food choices, and emotional eating. Higher scores represent more unhealthy parent dieting practices. Items ranged on a scale from 0-5 and were summed to create the scale which ranged from 0-20. | Secondary analysis was based on participants with complete data on the Parent Diet Practices measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
| Secondary | Parenting Practices: Engagement | Self-reported survey data; Parenting practices around child physical activity were measured by the Preschooler Physical Activity Parenting Practices (PPAPP) scale which has an engagement subscale. Parenting practices: Engagement was a 15 item subscale of the PPAPP survey with higher scores representing higher parent engagement practices. Items ranged on a scale from 1-5 and were summed to create the subscale which ranged from 15-75. | Secondary analysis was based on participants with complete data on the Parent Practices: Engagement measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
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| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | COACH: Strong Minds | This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy. COACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills | 0 | 58 | 0 | 58 | 0 | 58 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |