- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00628030
NOURISH: Nourishing Our Understanding of Role Modeling to Improve Support and Health (NOURISH)
Parent Skills Training to Enhance Weight Loss in Overweight Children
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Virginia
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Richmond, Virginia, Forente stater, 23284
- Virginia Commonwealth University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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:
- non-ambulatory,
- pregnant,
- 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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
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Participants in the NOURISH intervention will have 6 weekly face-to-face parent group sessions regarding healthy eating and physical activity.
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Placebo komparator: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Child BMI
Tidsramme: Basline, Posttest
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Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.
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Basline, Posttest
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Child Feeding
Tidsramme: 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).
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Basline, Posttest
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Child Quality of Life
Tidsramme: Basline, Posttest
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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
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Parental BMI
Tidsramme: Baseline, Posttest
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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.
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Baseline, Posttest
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Parental Dietary Intake of Fat
Tidsramme: Baseline, Posttest
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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.
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Baseline, Posttest
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Suzanne E. Mazzeo, Ph.D., Virginia Commonwealth University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PT101376
- 1R03HD056050-01A1 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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