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

September 30, 2021 updated by: Shari Barkin, MD, MSHS, Vanderbilt University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

610

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Smarter
Group sessions that meet six times over the course of three years with quarterly newsletters.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Early Childhood BMI Trajectory
Time Frame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
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)
Time Frame: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months
Percentage of Energy Intake from Fat
Time Frame: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months
Percentage of Energy Intake from Carbohydrates
Time Frame: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months
Percentage of Energy Intake from Protein
Time Frame: Baseline, 12 months, 24 months, and 36 months
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
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
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
Baseline, 12 months, 24 months, and 36 months
Parent BMI
Time Frame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
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
Baseline, 12 months, 24 months, and 36 months
Parent Triceps Skinfold
Time Frame: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months
Child Waist Circumference
Time Frame: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months
Child Triceps Skinfold
Time Frame: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Network
Time Frame: Baseline, 3 months, 12 months, and 36 months
Ties between participants
Baseline, 3 months, 12 months, and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
Nashville Metro Parks and Recreation Department
Nashville Public Library Foundation

Investigators

  • Principal Investigator: Shari Barkin, MD, MSHS, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 13, 2017

Study Completion (Actual)

July 6, 2017

Study Registration Dates

First Submitted

March 3, 2011

First Submitted That Met QC Criteria

March 15, 2011

First Posted (Estimate)

March 16, 2011

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100591
  • 5U01HL103620-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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