Portion Size Strategies for Management of Body Weight
14. maj 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
186
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
-
University Park, Pennsylvania, Forenede Stater, 16803
- Penn State University Laboratory for the Study of Human Ingestive Behavior
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Portion size instruction
Advice on diet, physical activity, and behavior change.
Instruction in food portion size.
|
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.
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.
|
|
Eksperimentel: Pre-portioned foods
Advice on diet, physical activity, and behavior change.
Provision of pre-portioned foods.
|
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.
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.
|
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.
Individuals assigned to this program will participate in individual instructional sessions that address principles of healthy eating while on a calorie-restricted diet.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Barbara J. Rolls, PhD, Penn State University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Roe LS, Rolls BJ. Which strategies to manage problem foods were related to weight loss in a randomized clinical trial? Appetite. 2020 Aug 1;151:104687. doi: 10.1016/j.appet.2020.104687. Epub 2020 Mar 29.
- James BL, Loken E, Roe LS, Rolls BJ. The Weight-Related Eating Questionnaire offers a concise alternative to the Three-Factor Eating Questionnaire for measuring eating behaviors related to weight loss. Appetite. 2017 Sep 1;116:108-114. doi: 10.1016/j.appet.2017.04.023. Epub 2017 Apr 22.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2012
Primær færdiggørelse (Faktiske)
1. marts 2015
Studieafslutning (Faktiske)
1. marts 2015
Datoer for studieregistrering
Først indsendt
15. november 2011
Først indsendt, der opfyldte QC-kriterier
17. november 2011
Først opslået (Skøn)
18. november 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. maj 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. maj 2015
Sidst verificeret
1. maj 2015
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PortionSize101
- R01DK059853 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .