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Translating Habituation Research to Interventions for Pediatric Obesity (EAT)

1. oktober 2020 oppdatert av: Leonard Epstein, State University of New York at Buffalo
The purpose of this center grant is to translate basic behavioral science on habituation theory into clinical intervention using a vertical hierarchical approach from laboratory studies to field studies to the clinical intervention to improve weight loss outcomes in pediatric obesity treatment.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Habituation is one factor that may be related to excess energy intake. Research has shown that the rate of habituation is inversely related to the amount of food consumed and slower habituation may be a factor that is relevant to obesity, as overweight youth and adults habituate slower and consume more energy than their peers. Habituation is a basic form of learning that is observed in many response systems. We believe that habituation is an important process that mediates food regulation during a meal and across meals. However, there has been no research in children that translates basic research on habituation to food into clinical interventions for pediatric obesity. In the first phase, we will implement a series of laboratory studies to assess the effects of stimulus specificity and variety and the simultaneous reduction of variety for high energy density foods on short (within meal) and long-term (across meal) habituation. The second phase is designed to implement a series of field studies that will extend basic research from the first phase as well as define the optimal interval for reducing variety to facilitate long-term habituation to high energy density foods in the natural environment. The third phase is designed to develop and pilot test a family-based behavioral intervention for children that incorporates findings from phase2 into a clinical intervention.

Studietype

Intervensjonell

Registrering (Faktiske)

94

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • New York
      • Buffalo, New York, Forente stater, 14214
        • University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine

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

8 år til 12 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Children ages 8-12 years of age
  • At or above 85th BMI percentile
  • Children must eat almost all meals with the exception of school lunch with the family.
  • Overweight parent

Exclusion Criteria:

  • Children who do not like the study foods, who are allergic to the study foods or who are on special diets and cannot consume the study foods.
  • Families with children with a co-morbid psychiatric diagnosis or parents who are depressed, have schizophrenia, substance abuse or a history of eating disorders.
  • The parent and child must not have any physical restrictions that would preclude them from making the requisite behavioral changes.
  • Children must be able to read at a 3rd grade reading level and must be able to demonstrate the ability to keep dietary and activity records in a stimulated interview.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Variety Group
Traditional family based weight control treatment program with components to reduce variety of high energy dense foods incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 behavioral intervention sessions.
Atferdsmessig: Variety Group
The intervention will consist of our traditional family based weight control intervention with elements of reducing variety of high energy dense foods for the variety group.
Atferdsmessig: Nutrition Education Control
The intervention will consist of our traditional family based weight control intervention.
Eksperimentell: Nutrition Education Control
Traditional family based weight control treatment program, without components from habituation theory incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 behavioral intervention sessions.
Atferdsmessig: Nutrition Education Control
The intervention will consist of our traditional family based weight control intervention.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change of Child Body Composition
Tidsramme: Baseline to 6 months
Child percent overweight difference from baseline to 6 month. The formula used to derive weight loss percentage was weight lost at 6 months divided by starting weight, multiplied by 100.
Baseline to 6 months
Change Parent Body Composition
Tidsramme: Baseline to 6 months
Parent Body Mass Index (kg/m^2) difference from baseline to 6 months
Baseline to 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Dietary Intake of Calories
Tidsramme: Baseline to 6 months
Energy intake was calculated for parents and children as the different from baseline to six months of calories consumed. The first pilot used the calories generated from the Food Frequency Questionnaire (FFQ) report however the second pilot used calories from 24 hour recalls based on the Center of Disease Control data base or food labels.
Baseline to 6 months
Change in Parent Delay Discounting
Tidsramme: Baseline to 6 months
Kirby, small, medium and large reinforcers. The Kirby monetary choice questionnaire will be used to measure implusivity in parents and children. Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards. An estimate of the participant's discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in K-values. (0.25 impulsive to 0.00016 not impulsive)
Baseline to 6 months
Change in Child Delay Discounting
Tidsramme: Baseline to 6 months
Kirby, small, medium and large reinforcers. The Kirby monetary choice questionnaire will be used to measure impulsivity in parents and children. Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards. An estimate of the participant's discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in higher K-values (0.25 vs 0.00016).
Baseline to 6 months
Changes in Variety Measures
Tidsramme: Baseline to 6 months
Variety of high energy density foods (RED) and low energy density foods (GREEN) were calculated from the Food Frequency Questionnaire (FFQ) for pilot 1 and 24 hour recalls (24-HR) for pilot 2. High energy dense food or Red foods are low in nutrient density. Most Red foods come from the Fats, Oils and Sweets groups and are to be used sparingly. Modified foods from the Fats, Oils, and Sweets group are still considered to be Red foods, even if their energy level is low. These foods contribute little nutrients to the diet and compete for consumption of healthier foods. Green foods are high in nutrient density and low in energy density. Most Green foods come from the fruit and vegetable groups. Serving sizes were based off the serving sizes used in United States Department of Agriculture (USDA) common serving sizes. Coding was based on the serving sizes of the specified food items and used to calculate the changes from baseline to six months.
Baseline to 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

State University of New York at Buffalo

Samarbeidspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Etterforskere

  • Hovedetterforsker: Leonard H. Epstein, Ph.D., SUNY Buffalo

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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. oktober 2009

Primær fullføring (Faktiske)

1. mars 2014

Studiet fullført (Faktiske)

1. mars 2014

Datoer for studieregistrering

Først innsendt

23. september 2010

Først innsendt som oppfylte QC-kriteriene

23. september 2010

Først lagt ut (Anslag)

24. september 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1083316-1-52205
  • 5U01DK088380 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared under the specifics of this protocol. Outcome data will be published.

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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