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NOURISH: Nourishing Our Understanding of Role Modeling to Improve Support and Health (NOURISH)

9 januari 2015 uppdaterad av: Virginia Commonwealth University

Parent Skills Training to Enhance Weight Loss in Overweight Children

The percentage of overweight children between the ages of 6 and 11 has nearly tripled in the last three decades, and rates are even higher among African Americans.Overweight children are at-risk for numerous health problems, thus effective treatments are urgently needed. This study will evaluate an innovative intervention for ethnically diverse parents (NOURISH), which focuses on helping parents role model and teach their children healthy behaviors.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Pediatric overweight is a national public health concern. The percentage of overweight children in the U.S. between the ages of 6 and 11 has nearly tripled in the last 3 decades. African American children are particularly at risk. Pediatric overweight is associated with numerous physical and psychological health problems. Moreover, overweight children are at significant risk for obesity in adulthood. Thus, a focus on pediatric overweight is an important step in the prevention of adult obesity.

Despite the urgent need for pediatric overweight interventions, outcomes of some of the most rigorous treatments are, at best, mixed. Although research has found that including parents in interventions for pediatric overweight has positive effects on outcomes, parental involvement is usually limited. Moreover, relatively few studies have included sufficient numbers of lower-SES, African American participants, a group at increased risk for pediatric overweight and associated complications. This study will evaluate the efficacy of an intensive intervention targeting ethnically diverse parents of overweight, children ages 6-11 (NOURISH-Nourishing Our Understanding of Role Modeling to Improve Support and Health).

Studietyp

Interventionell

Inskrivning (Faktisk)

184

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studieorter

  • Förenta staterna
    • Virginia
      • Richmond, Virginia, Förenta staterna, 23284
        • Virginia Commonwealth University

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

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • To qualify for participation, parents/caregivers must have a child between the ages of 6 and 11 with a BMI > the 85th percentile [128].
  • This child must also primarily reside in the participating caregiver's home.
  • Participants also need to speak English fluently, and be able to understand and follow basic instructions and perform simple exercises.

Exclusion Criteria:

  • Caregivers are ineligible if they are:

    1. non-ambulatory,
    2. pregnant,
    3. or have a clinical diagnosis that may be negatively impacted by exercise.
  • Parents whose children have a medical condition or developmental disorder that precludes weight loss using conventional diet and exercise methods are also ineligible for participation.

All parents meeting study criteria will be offered participation in the randomized trial comparing NOURISH with a control group.

Studieplan

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

Hur är studien utformad?

Designdetaljer

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

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: NOURISH
The first 2 waves and second 2 waves of participants will receive a 12 and 6 week face-to-face intervention (NOURISH), respectively. The interventions differ only in duration. They cover the same concepts which are grounded in Social Cognitive Theory (SCT). Throughout the interventions the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) will be emphasized. Weekly topics provide information about implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents will receive pedometers for themselves and 1 of their children. A one-hour booster session will be available for all intervention participants 2 months after completion of the interventions.
Beteende: NOURISH
Participants in the NOURISH intervention will have 6 weekly face-to-face parent group sessions regarding healthy eating and physical activity.
Placebo-jämförare: Wellness Group
The placebo control group will attend a group session moderated by an independent interventionist. This interventionist will be blinded to the Specific Aims and hypotheses of this study. The session will address the role of diet and exercise in pediatric overweight. In addition, control parents will receive pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants will be mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants will also be sent home one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
Övrig: Wellness Group
Participants in the Wellness Group will have one face-to-face group meeting and information regarding healthy eating and physical activity will be provided on a regular basis via mail.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Child BMI
Tidsram: Basline, Posttest
Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.
Basline, Posttest

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Child Feeding
Tidsram: Basline, Posttest
The Child Feeding Questionnaire (CFQ) measured parental approaches to and attitudes about feeding their children and the subscale "concern about child's weight" is reported below in the table. The subscale score was calculated by averaging the items (subscale score range: 3 to 15, higher scores represent greater risk). To compare groups, change scores were calculated by subtracting post-test values from baseline values (negative scores indicate decline in parental concern from baseline to post-test).
Basline, Posttest
Child Quality of Life
Tidsram: Basline, Posttest

Pediatric Health-Related Quality of Life (PedsQL4.0) change scores from baseline to posttest

We reported the Total Score. The PedsQL4.0 response scale ranges from 0 - 4. The items are reverse-scored for interpretability and higher scores indicate higher quality of life.

We used the Total Score, or the mean computed as the sum of all the items over the number of items answered on all the Scales.

The current report did not provide subscores.
Basline, Posttest
Parental BMI
Tidsram: Baseline, Posttest
Height and weight were measured by trained staff and used to calculate BMI. Change scores of parental BMI from baseline to posttest were calculated to show difference between treatment arms.
Baseline, Posttest
Parental Dietary Intake of Fat
Tidsram: Baseline, Posttest
Parents completed a 3 day dietary record which was reviewed by a dietitian and analyzed using the Nutrition Data System Software (NDS-R) to calculate parental fat intake. Change scores were calculated by subtracting post-test values from baseline values; thus, a negative score indicates a greater reduction in fat intake at post-testing.
Baseline, Posttest

Samarbetspartners och utredare

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

Sponsor

Virginia Commonwealth University

Samarbetspartners

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Utredare

  • Huvudutredare: Suzanne E. Mazzeo, Ph.D., Virginia Commonwealth University

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 april 2008

Primärt slutförande (Faktisk)

1 april 2010

Avslutad studie (Faktisk)

1 juli 2010

Studieregistreringsdatum

Först inskickad

22 februari 2008

Först inskickad som uppfyllde QC-kriterierna

3 mars 2008

Första postat (Uppskatta)

4 mars 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

19 januari 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 januari 2015

Senast verifierad

1 januari 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PT101376
  • 1R03HD056050-01A1 (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 Pediatrisk fetma

Kliniska prövningar på NOURISH

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