Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01316653
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : October 8, 2021
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Childhood Obesity Behavioral: GROW Healthier Behavioral: GROW Smarter Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories
Study Start Date : June 2011
Actual Primary Completion Date : June 13, 2017
Actual Study Completion Date : July 6, 2017
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: GROW Smarter
Library based program to promote early literacy
 Behavioral: GROW Smarter
Group sessions that meet six times over the course of three years with quarterly newsletters.
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.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Early Childhood BMI Trajectory [ Time Frame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months ]

Secondary Outcome Measures :
  1. Average daily energy intake (kcal) [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  2. Percentage of Energy Intake from Fat [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  3. Percentage of Energy Intake from Carbohydrates [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  4. Percentage of Energy Intake from Protein [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  5. Average daily time (minutes) spent in rest and sedentary behavior [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  6. Average daily time (minutes) spent in moderate and vigorous physical activity [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  7. Parent community center use with child [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
    never versus at least once

  8. Parent BMI [ Time Frame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months ]
  9. Parent Waist Circumference [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  10. Parent Triceps Skinfold [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  11. Child Waist Circumference [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]
  12. Child Triceps Skinfold [ Time Frame: Baseline, 12 months, 24 months, and 36 months ]

Other Outcome Measures:
  1. Social Network [ Time Frame: Baseline, 3 months, 12 months, and 36 months ]
    Ties between participants


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316653


Locations
Layout table for location information
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
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
Investigators
Layout table for investigator information
Principal Investigator: Shari Barkin, MD, MSHS Vanderbilt University Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:
Gesell SB, Sommer EC, Barkin SL. The 'GROW Social Network' datasets. Connections. 2020;40(1):123-128.
Gesell SB, Barkin SL, Ip EH, et al. Leveraging Emergent Social Networks to Reduce Sedentary Behavior in Low-Income Parents With Preschool-Aged Children. SAGE Open. 2021;11(3).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Shari Barkin, MD, MSHS, William K. Warren Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01316653    
Other Study ID Numbers: 100591
5U01HL103620-03 ( U.S. NIH Grant/Contract )
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overweight
Pediatric Obesity
 Overnutrition
Nutrition Disorders
Body Weight