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Portion Size Strategies for Management of Body Weight

14. mai 2015 oppdatert av: Barbara J. Rolls, Penn State University

The primary aim of this research is to determine the efficacy of two portion-control strategies to achieve sustainable dietary and behavior changes and to promote weight loss and maintenance. A randomized controlled trial will test two approaches to managing portion sizes: one that gives individuals skills and tools to help them make appropriate portion choices, and another that focuses on consumption of pre-portioned foods in order to limit exposure to large portions in the personal food environment. A third group will receive a basic nutritional program to promote weight loss.

The second aim of the research is to determine the effects of the programs on knowledge and consumption of appropriate portions, as assessed by innovative assessment methods and multiple-pass dietary recalls. The third aim is to conduct exploratory analyses of individual factors that may influence the response to the portion-control interventions, such as psychosocial indicators, blood biomarkers, and measures of adherence to the interventions. The expected outcome of the project is that it will lead to the development of specific, evidence-based strategies to help control portion sizes in order to manage weight.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

186

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
    • Pennsylvania
      • University Park, Pennsylvania, Forente stater, 16803
        • Penn State University Laboratory for the Study of Human Ingestive Behavior

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

20 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Body mass index of 28 to 45 kg/m squared
  • Able to safely engage in physical activity (walking)
  • Able to attend regular instructional sessions at University Park, Pennsylvania

Exclusion Criteria:

  • have a medical condition diagnosed by a physician that precludes participation
  • report symptoms indicative of depression or disordered eating
  • report serious food allergies or intolerance
  • current or planned participation in a weight-loss program
  • pregnant or lactating or planning to become pregnant in the next 18 months

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: Portion size instruction
Advice on diet, physical activity, and behavior change. Instruction in food portion size.
Atferdsmessig: Advice on diet, physical activity, and behavior change
Individuals will participate in individual sessions with Registered Dietitians providing basic instruction in principles of weight loss. The program will instruct individuals on the principles of healthy eating and nutrition during calorie restriction. These materials include one module with general information on the importance of limiting portion sizes. The program will also include instruction on physical activity and behavioral strategies for weight loss.
Atferdsmessig: Instruction in food portion size
Individuals assigned to this program will participate in individual instructional sessions with specialized materials and tools that address food selection and choosing appropriate portion sizes of various foods.
Eksperimentell: Pre-portioned foods
Advice on diet, physical activity, and behavior change. Provision of pre-portioned foods.
Atferdsmessig: Advice on diet, physical activity, and behavior change
Individuals will participate in individual sessions with Registered Dietitians providing basic instruction in principles of weight loss. The program will instruct individuals on the principles of healthy eating and nutrition during calorie restriction. These materials include one module with general information on the importance of limiting portion sizes. The program will also include instruction on physical activity and behavioral strategies for weight loss.
Annen: Provision of pre-portioned foods
Individuals assigned to this program will be provided with commercially available pre-portioned foods and will be taught effective ways to incorporate them into their daily diet.
Aktiv komparator: Comparison
Advice on diet, physical activity, and behavior change. Advice on healthy eating for weight loss.
Atferdsmessig: Advice on diet, physical activity, and behavior change
Individuals will participate in individual sessions with Registered Dietitians providing basic instruction in principles of weight loss. The program will instruct individuals on the principles of healthy eating and nutrition during calorie restriction. These materials include one module with general information on the importance of limiting portion sizes. The program will also include instruction on physical activity and behavioral strategies for weight loss.
Atferdsmessig: Advice on healthy eating for weight loss
Individuals assigned to this program will participate in individual instructional sessions that address principles of healthy eating while on a calorie-restricted diet.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in body weight
Tidsramme: Months 0 to 12
Body weight will be measured at multiple time points during the 12-month trial; the main outcome will be the weight trajectory across this time
Months 0 to 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in portion size selection, perception, and knowledge
Tidsramme: Months 0, 3, 6, & 12
Computerized assessment of various foods (for self-selected portion sizes, estimation of calorie content, and satiety value) and general knowledge about portion size
Months 0, 3, 6, & 12
Change in portion size consumption
Tidsramme: Months 0, 3, 6, & 12
Portion sizes consumed in various food categories as assessed by diet recalls and diet records
Months 0, 3, 6, & 12
Change in blood biomarkers
Tidsramme: Months 0, 3, 6, & 12
Fasting lipids, glucose, insulin, and calculated insulin resistance
Months 0, 3, 6, & 12
Change in waist circumference
Tidsramme: Months 0, 3, 6, & 12
Months 0, 3, 6, & 12
Change in blood pressure
Tidsramme: Months 0, 3, 6, & 12
Months 0, 3, 6, & 12
Change in dietary intakes
Tidsramme: Months 0, 3, 6, 9, & 12
Energy intake, nutrient intakes, dietary energy density, food group intakes, and diet quality from three days of 24-hour diet recalls
Months 0, 3, 6, 9, & 12
Change in step counts
Tidsramme: Months 0, 3, 6, 9, & 12
Daily step counts from pedometers
Months 0, 3, 6, 9, & 12
Change in attitudes and behaviors related to food and eating
Tidsramme: Months 0, 1, 3, 6, & 12
Self-reported eating attitudes and behaviors on multiple questionnaires
Months 0, 1, 3, 6, & 12
Change in psychosocial characteristics
Tidsramme: Months 0, 3, 6, & 12
Questionnaires measuring psychosocial characteristics including impulsivity, variety-seeking, and self-efficacy
Months 0, 3, 6, & 12
Intervention adherence
Tidsramme: Month 12
Number of sessions attended, number of diet and activity records completed, and frequency of using intervention strategies during the entire trial
Month 12

Samarbeidspartnere og etterforskere

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

Sponsor

Penn State University

Samarbeidspartnere

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

Etterforskere

  • Hovedetterforsker: Barbara J. Rolls, PhD, Penn State University

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. juli 2012

Primær fullføring (Faktiske)

1. mars 2015

Studiet fullført (Faktiske)

1. mars 2015

Datoer for studieregistrering

Først innsendt

15. november 2011

Først innsendt som oppfylte QC-kriteriene

17. november 2011

Først lagt ut (Anslag)

18. november 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. mai 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. mai 2015

Sist bekreftet

1. mai 2015

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • PortionSize101
  • R01DK059853 (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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