Competency-based Approaches to Community Health (COACH)
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| ClinicalTrials.gov Identifier: NCT03141151 |
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Recruitment Status :
Completed
First Posted : May 4, 2017
Results First Posted : March 20, 2020
Last Update Posted : March 20, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obesity, Childhood | Behavioral: COACH: Healthy Bodies Behavioral: COACH: Strong Minds | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 117 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Masking Description: | The investigators and data collectors will be blinded to randomization status. Because this is a behavioral intervention, the participants and interventionists will be unblinded. |
| Primary Purpose: | Treatment |
| Official Title: | Competency-based Approaches to Community Health |
| Actual Study Start Date : | May 16, 2017 |
| Actual Primary Completion Date : | August 31, 2018 |
| Actual Study Completion Date : | August 31, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Behavioral: COACH: Healthy Bodies
Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family. |
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Active Comparator: 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.
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Behavioral: COACH: Strong Minds
School Readiness Intervention focusing on literacy and parent skills |
- Change in Child Body Mass Index [ Time Frame: Baseline, 4 months, 7 months, 1 year ]child BMI trajectory across 12 months; BMI differences over time are estimates from the longitudinal mixed-effects regression model
- Child Diet: Soda [ Time Frame: 4 months ]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.)
- Child Physical Activity [ Time Frame: 4 months ]Parent-reported survey data
- Parent BMI [ Time Frame: 4 months ]
- Parent Diet Practices [ Time Frame: 4 months ]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.
- Parenting Practices: Engagement [ Time Frame: 4 months ]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.
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| Ages Eligible for Study: | 3 Years to 5 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Three-to-five year old child
- Spanish or English-speaking
- Child's BMI ≥ 50%
- Parental commitment to participate in a year long study
- Consistent phone access
- Parent age ≥ 18 years
- Child completion of baseline data collection on height, weight, and waist circumference and all willing survey items completed by the parent
- Parents and children must be healthy (parents with controlled medical conditions will also be eligible).
- Dyad must be considered underserved which will be indicated by the parents self-reporting if they or someone in their household participate in one of these programs or services: TennCare, CoverKids, WIC, Food Stamps (SNAP), Free and Reduced Price School Lunch and Breakfast, Families First (TANF), and/or subsidized housing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141151
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37212 | |
| Principal Investigator: | William Heerman, MD MPH | Vanderbilt University Medical Center |
Documents provided by Bill Heerman, Vanderbilt University Medical Center:
| Responsible Party: | Bill Heerman, Assistant Professor of Pediatrics, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT03141151 |
| Other Study ID Numbers: |
170420 |
| First Posted: | May 4, 2017 Key Record Dates |
| Results First Posted: | March 20, 2020 |
| Last Update Posted: | March 20, 2020 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Pediatric Obesity Obesity Overnutrition |
Nutrition Disorders Overweight Body Weight |