Obesity, Childhood
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCOACH: Healthy Bodies
Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.
BEHAVIORALCOACH: Strong Minds
School Readiness Intervention focusing on literacy and parent skills
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
1. Three-to-five year old child 2. Spanish or English-speaking 3. Child's BMI ≥ 50% 4. Parental commitment to participate in a year long study 5. Consistent phone access 6. Parent age ≥ 18 years 7. Child completion of baseline data collection on height, weight, and waist circumference and all willing survey items completed by the parent 8. Parents and children must be healthy (parents with controlled medical conditions will also be eligible). 9. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Child Body Mass Index | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Diet: Soda | 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 | 4 months | Parent-reported survey data |
| Parent BMI | 4 months | — |
| Parent Diet Practices | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 59 |
| 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 | 58 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | COACH: Healthy Bodies | Total | COACH: Strong Minds |
|---|---|---|---|
| Age, Categorical <=18 years | 59 Participants | 117 Participants | 58 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.3 years STANDARD_DEVIATION 0.8 | 4.2 years STANDARD_DEVIATION 0.8 | 4.2 years STANDARD_DEVIATION 0.8 |
| Race/Ethnicity, Customized Hispanic | 59 Participants | 117 Participants | 58 Participants |
| Region of Enrollment United States | 59 participants | 117 participants | 59 participants |
| Sex: Female, Male Female | 32 Participants | 63 Participants | 31 Participants |
| Sex: Female, Male Male | 27 Participants | 54 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 58 |
| other Total, other adverse events | 0 / 59 | 0 / 58 |
| serious Total, serious adverse events | 0 / 59 | 0 / 58 |
Outcome results
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
Time frame: Baseline, 4 months, 7 months, 1 year
Population: Number analyzed differs across each time point as it relates to retention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COACH: Healthy Bodies | Change in Child Body Mass Index | Baseline | 18.1 kg/m^2 | Standard Deviation 2.2 |
| COACH: Healthy Bodies | Change in Child Body Mass Index | 4 months | 18.1 kg/m^2 | Standard Deviation 2.5 |
| COACH: Healthy Bodies | Change in Child Body Mass Index | 7 months | 18.0 kg/m^2 | Standard Deviation 2.5 |
| COACH: Healthy Bodies | Change in Child Body Mass Index | 12 months | 18.5 kg/m^2 | Standard Deviation 2.7 |
| COACH: Strong Minds | Change in Child Body Mass Index | 12 months | 18.7 kg/m^2 | Standard Deviation 3.7 |
| COACH: Strong Minds | Change in Child Body Mass Index | Baseline | 18.1 kg/m^2 | Standard Deviation 3 |
| COACH: Strong Minds | Change in Child Body Mass Index | 7 months | 18.4 kg/m^2 | Standard Deviation 3.3 |
| COACH: Strong Minds | Change in Child Body Mass Index | 4 months | 18.2 kg/m^2 | Standard Deviation 3.4 |
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.)
Time frame: 4 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COACH: Healthy Bodies | Child Diet: Soda | 0.17 Sodas/day | Standard Deviation 0.27 |
| COACH: Strong Minds | Child Diet: Soda | 0.19 Sodas/day | Standard Deviation 0.31 |
Secondary
Child Physical Activity
Parent-reported survey data
Time frame: 4 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COACH: Healthy Bodies | Child Physical Activity | 2.00 Child active days per week | Standard Deviation 2.6 |
| COACH: Strong Minds | Child Physical Activity | 1.62 Child active days per week | Standard Deviation 2.63 |
Secondary
Parent BMI
Time frame: 4 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COACH: Healthy Bodies | Parent BMI | 30.44 kg/m^2 | Standard Deviation 5.86 |
| COACH: Strong Minds | Parent BMI | 31.57 kg/m^2 | Standard Deviation 6.72 |
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.
Time frame: 4 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COACH: Healthy Bodies | Parent Diet Practices | 5.04 score on a scale | Standard Deviation 4.09 |
| COACH: Strong Minds | Parent Diet Practices | 5.22 score on a scale | Standard Deviation 4.02 |
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.
Time frame: 4 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COACH: Healthy Bodies | Parenting Practices: Engagement | 53.79 score on a scale | Standard Deviation 12.66 |
| COACH: Strong Minds | Parenting Practices: Engagement | 49.52 score on a scale | Standard Deviation 13.06 |