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

30. september 2021 oppdatert 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

610

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

3 år til 5 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Eksperimentell: 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)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Early Childhood BMI Trajectory
Tidsramme: Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Social Network
Tidsramme: Baseline, 3 months, 12 months, and 36 months
Ties between participants
Baseline, 3 months, 12 months, and 36 months

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2011

Primær fullføring (Faktiske)

13. juni 2017

Studiet fullført (Faktiske)

6. juli 2017

Datoer for studieregistrering

Først innsendt

3. mars 2011

Først innsendt som oppfylte QC-kriteriene

15. mars 2011

Først lagt ut (Anslag)

16. mars 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. oktober 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. september 2021

Sist bekreftet

1. september 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

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

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