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

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ClinicalTrials.gov Identifier: NCT01316653
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : October 3, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nashville Metro Parks and Recreation Department
Nashville Public Library Foundation
Information provided by (Responsible Party):
Shari Barkin, MD, MSHS, Vanderbilt University

March 3, 2011
March 16, 2011
October 3, 2018
June 2011
June 13, 2017   (Final data collection date for primary outcome measure)
Early Childhood BMI Trajectory [ Time Frame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months ]
  • Early Childhood BMI Trajectory [ Time Frame: Baseline, 3 mos, 9 mos, 12 mos, 24 mos, and 36 mos ]
  • Child Body Fat (%) [ Time Frame: Baselline, 12 mos, 24 mos, and 36 mos ]
  • Child Waist Circumference [ Time Frame: Baselline, 12 mos, 24 mos, and 36 mos ]
  • Child Waist to Hip Ratio [ Time Frame: Baseline 12 mos, 24 mos, and 36 mos ]
Complete list of historical versions of study NCT01316653 on ClinicalTrials.gov Archive Site
  • Average daily energy intake (kcal) [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  • Percentage of Energy Intake from Fat [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  • Percentage of Energy Intake from Carbohydrates [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  • Percentage of Energy Intake from Protein [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  • Average daily time (minutes) spent in rest and sedentary behavior [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  • Average daily time (minutes) spent in moderate and vigorous physical activity [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  • Parent community center use with child [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
    never versus at least once
  • Parent BMI [ Time Frame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months ]
  • Parent Waist Circumference [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  • Parent Triceps Skinfold [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  • Child Waist Circumference [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  • Child Triceps Skinfold [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  • Parental BMI Trajectory [ Time Frame: Baseline, 3 mos, 9 mos, 12 mos, 24 mos, and 36 mos ]
  • Parental Body Fat (%) [ Time Frame: Baselline, 12 mos, 24 mos, and 36 mos ]
  • Parental Waist Circumference [ Time Frame: Baseline, 12 mos, 24 mos, 36 mos ]
  • Parental Waist to Hip Ratio [ Time Frame: Baseline, 12 mos, 24 mos, 36 mos ]
Social Network [ Time Frame: Baseline, 3 months, 24 months, and 36 months ]
Ties between participants
Not Provided
 
Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories
Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Overweight and Obesity
  • Childhood Obesity
  • Behavioral: GROW Healthier
    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)
  • Behavioral: GROW Smarter
    Group sessions that meet six times over the course of three years with quarterly newsletters.
  • Active Comparator: GROW Smarter
    Library based program to promote early literacy
    Intervention: Behavioral: GROW Smarter
  • Experimental: GROW Healthier
    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.
    Interventions:
    • Behavioral: GROW Healthier
    • Behavioral: GROW Smarter

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
610
650
July 6, 2017
June 13, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
3 Years to 5 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01316653
100591
5U01HL103620-03 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Shari Barkin, MD, MSHS, Vanderbilt University
Vanderbilt University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Nashville Metro Parks and Recreation Department
  • Nashville Public Library Foundation
Principal Investigator: Shari Barkin, MD, MSHS Vanderbilt University Medical Center
Vanderbilt University Medical Center
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP