Clinical trial NCT01316653: Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories
Official title: Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Childhood Obesity
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Nashville Metro Parks and Recreation Department
name: Nashville Public Library Foundation
First posted: 2011-03-16
Enrollment: 610
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Early Childhood BMI Trajectory
timeFrame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
Secondary outcomes:
measure: Average daily energy intake (kcal)
timeFrame: Baseline, 12 months, 24 months, and 36 months
measure: Percentage of Energy Intake from Fat
timeFrame: Baseline, 12 months, 24 months, and 36 months
measure: Percentage of Energy Intake from Carbohydrates
timeFrame: Baseline, 12 months, 24 months, and 36 months
measure: Percentage of Energy Intake from Protein
timeFrame: Baseline, 12 months, 24 months, and 36 months
measure: Average daily time (minutes) spent in rest and sedentary behavior
timeFrame: Baseline, 12 months, 24 months, and 36 months
measure: Average daily time (minutes) spent in moderate and vigorous physical activity
timeFrame: Baseline, 12 months, 24 months, and 36 months
measure: Parent community center use with child
timeFrame: Baseline, 12 months, 24 months, and 36 months
measure: Parent BMI
timeFrame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
measure: Parent Waist Circumference
timeFrame: Baseline, 12 months, 24 months, and 36 months
measure: Parent Triceps Skinfold
timeFrame: Baseline, 12 months, 24 months, and 36 months
measure: Child Waist Circumference
timeFrame: Baseline, 12 months, 24 months, and 36 months
measure: Child Triceps Skinfold
timeFrame: Baseline, 12 months, 24 months, and 36 months
Other outcomes:
measure: Social Network
timeFrame: Baseline, 3 months, 12 months, and 36 months
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Shari Barkin, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Oelsner KT, Guo Y, To SB, Non AL, Barkin SL. Maternal BMI as a predictor of methylation of obesity-related genes in saliva samples from preschool-age Hispanic children at-risk for obesity. BMC Genomics. 2017 Jan 9;18(1):57. doi: 10.1186/s12864-016-3473-9.
citation: Stevens J, Pratt C, Boyington J, Nelson C, Truesdale KP, Ward DS, Lytle L, Sherwood NE, Robinson TN, Moore S, Barkin S, Cheung YK, Murray DM. Multilevel Interventions Targeting Obesity: Research Recommendations for Vulnerable Populations. Am J Prev Med. 2017 Jan;52(1):115-124. doi: 10.1016/j.amepre.2016.09.011. Epub 2016 Oct 26.
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