This trial is active, not recruiting.

Conditions overweight and obesity, childhood obesity
Treatments grow healthier, grow smarter
Sponsor Vanderbilt University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date June 2011
End date June 2017
Trial size 610 participants
Trial identifier NCT01316653, 100591, 5UO1HL103620-03


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(Active Comparator)
Library based program to promote early literacy
grow smarter
Group sessions that meet six times over the course of three years with quarterly newsletters.
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.
grow healthier
Group sessions that meet once weekly for 3 months (intensive phase), 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)
grow smarter
Group sessions that meet six times over the course of three years with quarterly newsletters.

Primary Outcomes

Early Childhood BMI Trajectory
time frame: Baseline, 12 mos, 24 mos, and 36 mos

Secondary Outcomes

Parental BMI and weight
time frame: Baseline, 12 mos, 24 mos, and 36 mos
Parental Triceps Skin fold Thickness
time frame: Baselline, 12 mos, 24 mos, and 36 mos
Parental Waist Circumference
time frame: Baseline, 12 mos, 24 mos, 36 mos
Child Triceps Skin fold Thickness
time frame: Baseline, 12, 24,36 months
Child waist circumference
time frame: Baseline,12, 24, 36 months

Eligibility Criteria

Male or female participants from 3 years up to 5 years old.

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

Additional Information

Official title Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories
Principal investigator Shari Barkin, MD, MSHS
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 patters 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 policy changes around obesity prevention. Moreover, working with the study's community partners, the investigators will evaluate how this approach affects local policy.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.