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Completed

NCT Number: NCT01316653

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.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GROW Healthier

Behavioral

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)

GROW Smarter

Behavioral

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

Primary outcomes

  1. Early Childhood BMI Trajectory

    Time frame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months

Secondary outcomes

  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 outcomes

  1. Social Network

    Time frame: Baseline, 3 months, 12 months, and 36 months

    Ties between participants

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

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

Registry information

Acronym: GROW

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2011
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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