Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories

Study Overview
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Brief Summary
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The purpose of this study is to conduct a randomized controlled trial that examines how a family based, community centered intervention effects early childhood BMI trajectories.

Detailed Description
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Increases in sedentary lifestyle and high calorie food consumption, among other factors, have contributed to epidemic levels of childhood obesity in the US. Children who are overweight during the preschool period are more likely to become overweight adolescents and obese adults. Food preferences and activity habits set in early childhood can profoundly influence lifelong trajectories for Body Mass Index (BMI) and health. Specifically, rapid BMI gain in early childhood has been established to affect adulthood mortality and morbidity. Unfortunately, the longer such unhealthy patterns are in place, the more difficult it can be to reverse them. Therefore, healthy lifestyle interventions targeted at children as early as preschool have enormous potential to affect lifelong health. Furthermore, nutrition and activity patterns are determined not only at the child level, but within the family and the community. This study will assess the impact of a family-based and community centered multilevel behavioral intervention addressing nutrition and physical activity with high risk parent-preschool children dyads to promote pediatric obesity prevention. The 7 year study will follow 600 parent preschool child dyads, half of whom will be randomized into the intervention condition which will utilize a health literate approach, build new social networks, utilize behavior modification tools including goal setting, self monitoring, and problem solving, and create behavior-environmental synergy with cues to action for use of the built environment for healthy behaviors. Both the intervention and control group (separately) will receive the control condition in which parent-child dyads will receive a literacy promotion/school success curriculum. The primary outcome of interest will be early childhood BMI trajectories measured at multiple time points over the three year RCT. Additional measures collected throughout the study from children and parents will include: tricep skin fold, waist circumference, actigraphy, 3-day diet recalls, questionnaires, social network data, and saliva to assess a genetics/epigenetics associated with obesity. Consistent with a multilevel systems approach, the investigators will develop and assess built environment changes related to obesity prevention. Moreover, working with the study's community partners, the investigators will evaluate how this approach affects local policy.

Official Title
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Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories

Conditions
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Overweight and Obesity, Childhood Obesity

Intervention / Treatment
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* Behavioral: GROW Healthier
* Behavioral: GROW Smarter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English or Spanish speaking Address in select zip code regions around participating Metro community centers Parental commitment to consistent participation Consistent phone access for 3 years Child aged 3-5 years old Child BMI ≥ 50% and < 95% (no diagnosis of failure to thrive or difficulty with appropriate weight gain) Healthy parent and child (without medical conditions necessitating limited physical activity) Parent ≥ 18 years of age Exclusion Criteria: Non English or Spanish speaking Address outside select zip code regions around participating Metro community centers Lack of parental commitment to consistent participation Lack of consistent phone access Child outside specified age range Child BMI < 50% or ≥ 95% Parents and/or children who are diagnosed with medical illnesses where regular exercise might be contraindicated Parent < 18 years of age

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GROW Smarter<br>Library based program to promote early literacy | Behavioral: GROW Smarter<br>* Group sessions that meet six times over the course of three years with quarterly newsletters.<br>|
| Experimental: GROW Healthier<br>Healthy lifestyle intervention focused on building healthy lifestyle skills for preschool children and participating parents and building new social networks between the intervention group members. | Behavioral: GROW Healthier<br>* Group sessions that meet once weekly for 3 months (intensive phase) with choice of phone call session as preferred by participant, phone call coaching monthly for 9 months (maintenance phase), and monthly cues to action to use one's built environment for healthy activities for 24 months (sustainability phase)<br>Behavioral: GROW Smarter<br>* Group sessions that meet six times over the course of three years with quarterly newsletters.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Childhood BMI Trajectory |  | Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily energy intake (kcal) |  | Baseline, 12 months, 24 months, and 36 months | 
| Percentage of Energy Intake from Fat |  | Baseline, 12 months, 24 months, and 36 months | 
| Percentage of Energy Intake from Carbohydrates |  | Baseline, 12 months, 24 months, and 36 months | 
| Percentage of Energy Intake from Protein |  | Baseline, 12 months, 24 months, and 36 months | 
| Average daily time (minutes) spent in rest and sedentary behavior |  | Baseline, 12 months, 24 months, and 36 months | 
| Average daily time (minutes) spent in moderate and vigorous physical activity |  | Baseline, 12 months, 24 months, and 36 months | 
| Parent community center use with child | never versus at least once | Baseline, 12 months, 24 months, and 36 months | 
| Parent BMI |  | Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months | 
| Parent Waist Circumference |  | Baseline, 12 months, 24 months, and 36 months | 
| Parent Triceps Skinfold |  | Baseline, 12 months, 24 months, and 36 months | 
| Child Waist Circumference |  | Baseline, 12 months, 24 months, and 36 months | 
| Child Triceps Skinfold |  | Baseline, 12 months, 24 months, and 36 months |