Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
NCT Number: NCT01316653
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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Notify Me3 year–5 year
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37232, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Group sessions that meet six times over the course of three years with quarterly newsletters.
Time frame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
Time frame: Baseline, 12 months, 24 months, and 36 months
Time frame: Baseline, 12 months, 24 months, and 36 months
Time frame: Baseline, 12 months, 24 months, and 36 months
Time frame: Baseline, 12 months, 24 months, and 36 months
Time frame: Baseline, 12 months, 24 months, and 36 months
Time frame: Baseline, 12 months, 24 months, and 36 months
Time frame: Baseline, 12 months, 24 months, and 36 months
never versus at least once
Time frame: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
Time frame: Baseline, 12 months, 24 months, and 36 months
Time frame: Baseline, 12 months, 24 months, and 36 months
Time frame: Baseline, 12 months, 24 months, and 36 months
Time frame: Baseline, 12 months, 24 months, and 36 months
Time frame: Baseline, 3 months, 12 months, and 36 months
Ties between participants
Vanderbilt University
Other
Acronym: GROW
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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