Trial record 7 of 44 for:    Open Studies | "Body Mass Index"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Vanderbilt University
Sponsor:
Collaborators:
Nashville Metro Parks and Recreation Department
Nashville Public Library Foundation
Information provided by (Responsible Party):
Shari Barkin, MD, MSHS, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01316653
First received: March 3, 2011
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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 Intervention
Overweight and Obesity
Childhood Obesity
Behavioral: GROW Healthier
Behavioral: GROW Smarter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Early Childhood BMI Trajectory [ Time Frame: Baseline, 12 mos, 24 mos, and 36 mos ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parental BMI and weight [ Time Frame: Baseline, 12 mos, 24 mos, and 36 mos ] [ Designated as safety issue: No ]
  • Parental Body Fat (%) [ Time Frame: Baselline, 12 mos, 24 mos, and 36 mos ] [ Designated as safety issue: No ]
    Triceps skin fold

  • Parental Waist Circumference [ Time Frame: Baseline, 12 mos, 24 mos, 36 mos ] [ Designated as safety issue: No ]
  • Child body fat (%) [ Time Frame: Baseline, 12, 24,36 months ] [ Designated as safety issue: No ]
    triceps skin fold

  • Child waist circumference [ Time Frame: Baseline,12, 24, 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: June 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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), phone call coaching monthly for 9 months (maintenance phase), and monthly for 24 months (sustainability phase)
Behavioral: GROW Smarter
Group sessions that meet six times over the course of three years with quarterly newsletters.

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 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 and utilize behavior modification tools including goal setting, self monitoring, and problem solving. 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 genetic risk score 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.

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316653

Contacts
Contact: Jeanelle D Braxton, MPA 615-875-3019 jeanelle.braxton@vanderbilt.edu
Contact: Karen Hagan, BA 615-936-8066 karen.hagan@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Nashville Metro Parks and Recreation Department
Nashville Public Library Foundation
Investigators
Principal Investigator: Shari Barkin, MD, MSHS Vanderbilt University
  More Information

No publications provided

Responsible Party: Shari Barkin, MD, MSHS, William K. Warren Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01316653     History of Changes
Other Study ID Numbers: 100591, 5UO1HL103620-03
Study First Received: March 3, 2011
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overweight
Pediatric Obesity
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014