Trial Outcomes & Findings for Competency-based Approaches to Community Health (NCT NCT03141151)
NCT ID: NCT03141151
Last Updated: 2020-03-20
Results Overview
child BMI trajectory across 12 months; BMI differences over time are estimates from the longitudinal mixed-effects regression model
COMPLETED
NA
117 participants
Baseline, 4 months, 7 months, 1 year
2020-03-20
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
58
|
|
Overall Study
COMPLETED
|
53
|
54
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Competency-based Approaches to Community Health
Baseline characteristics by cohort
| Measure |
COACH: Healthy Bodies
n=59 Participants
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.
|
COACH: Strong Minds
n=58 Participants
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
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
59 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4.3 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
4.2 years
STANDARD_DEVIATION 0.8 • n=7 Participants
|
4.2 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
59 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
59 participants
n=7 Participants
|
117 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 7 months, 1 yearPopulation: Number analyzed differs across each time point as it relates to retention
child BMI trajectory across 12 months; BMI differences over time are estimates from the longitudinal mixed-effects regression model
Outcome measures
| Measure |
COACH: Healthy Bodies
n=59 Participants
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.
|
COACH: Strong Minds
n=58 Participants
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
|
|---|---|---|
|
Change in Child Body Mass Index
7 months
|
18.0 kg/m^2
Standard Deviation 2.5
|
18.4 kg/m^2
Standard Deviation 3.3
|
|
Change in Child Body Mass Index
Baseline
|
18.1 kg/m^2
Standard Deviation 2.2
|
18.1 kg/m^2
Standard Deviation 3.0
|
|
Change in Child Body Mass Index
4 months
|
18.1 kg/m^2
Standard Deviation 2.5
|
18.2 kg/m^2
Standard Deviation 3.4
|
|
Change in Child Body Mass Index
12 months
|
18.5 kg/m^2
Standard Deviation 2.7
|
18.7 kg/m^2
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: 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.
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.)
Outcome measures
| Measure |
COACH: Healthy Bodies
n=56 Participants
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.
|
COACH: Strong Minds
n=55 Participants
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
|
|---|---|---|
|
Child Diet: Soda
|
0.17 Sodas/day
Standard Deviation 0.27
|
0.19 Sodas/day
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: 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.
Parent-reported survey data
Outcome measures
| Measure |
COACH: Healthy Bodies
n=55 Participants
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.
|
COACH: Strong Minds
n=55 Participants
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
|
|---|---|---|
|
Child Physical Activity
|
2.00 Child active days per week
Standard Deviation 2.60
|
1.62 Child active days per week
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: 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.
Outcome measures
| Measure |
COACH: Healthy Bodies
n=50 Participants
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.
|
COACH: Strong Minds
n=49 Participants
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
|
|---|---|---|
|
Parent BMI
|
30.44 kg/m^2
Standard Deviation 5.86
|
31.57 kg/m^2
Standard Deviation 6.72
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: 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.
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.
Outcome measures
| Measure |
COACH: Healthy Bodies
n=55 Participants
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.
|
COACH: Strong Minds
n=54 Participants
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
|
|---|---|---|
|
Parent Diet Practices
|
5.04 score on a scale
Standard Deviation 4.09
|
5.22 score on a scale
Standard Deviation 4.02
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: 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.
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.
Outcome measures
| Measure |
COACH: Healthy Bodies
n=56 Participants
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.
|
COACH: Strong Minds
n=54 Participants
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
|
|---|---|---|
|
Parenting Practices: Engagement
|
53.79 score on a scale
Standard Deviation 12.66
|
49.52 score on a scale
Standard Deviation 13.06
|
Adverse Events
COACH: Healthy Bodies
COACH: Strong Minds
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
William Heerman, MD MPH
Vanderbilt University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place