Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

30 september 2021 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

610

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232
        • Vanderbilt University Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

3 år till 5 år (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: GROW Smarter
Library based program to promote early literacy
Group sessions that meet six times over the course of three years with quarterly newsletters.
Experimentell: 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.
Group sessions that meet six times over the course of three years with quarterly newsletters.
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)

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Early Childhood BMI Trajectory
Tidsram: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Average daily energy intake (kcal)
Tidsram: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months
Percentage of Energy Intake from Fat
Tidsram: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months
Percentage of Energy Intake from Carbohydrates
Tidsram: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months
Percentage of Energy Intake from Protein
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months
Parent community center use with child
Tidsram: Baseline, 12 months, 24 months, and 36 months
never versus at least once
Baseline, 12 months, 24 months, and 36 months
Parent BMI
Tidsram: 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
Tidsram: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months
Parent Triceps Skinfold
Tidsram: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months
Child Waist Circumference
Tidsram: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months
Child Triceps Skinfold
Tidsram: Baseline, 12 months, 24 months, and 36 months
Baseline, 12 months, 24 months, and 36 months

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Social Network
Tidsram: Baseline, 3 months, 12 months, and 36 months
Ties between participants
Baseline, 3 months, 12 months, and 36 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2011

Primärt slutförande (Faktisk)

13 juni 2017

Avslutad studie (Faktisk)

6 juli 2017

Studieregistreringsdatum

Först inskickad

3 mars 2011

Först inskickad som uppfyllde QC-kriterierna

15 mars 2011

Första postat (Uppskatta)

16 mars 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 oktober 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 september 2021

Senast verifierad

1 september 2021

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 100591
  • 5U01HL103620-03 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Barnfetma

Kliniska prövningar på GROW Smarter

3
Prenumerera