Portion Size Strategies for Management of Body Weight
14 mei 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
186
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Pennsylvania
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University Park, Pennsylvania, Verenigde Staten, 16803
- Penn State University Laboratory for the Study of Human Ingestive Behavior
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
20 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Portion size instruction
Advice on diet, physical activity, and behavior change.
Instruction in food portion size.
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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.
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Experimenteel: Pre-portioned foods
Advice on diet, physical activity, and behavior change.
Provision of pre-portioned foods.
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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.
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Actieve vergelijker: Comparison
Advice on diet, physical activity, and behavior change.
Advice on healthy eating for weight loss.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in body weight
Tijdsspanne: Months 0 to 12
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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
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Months 0 to 12
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in portion size selection, perception, and knowledge
Tijdsspanne: Months 0, 3, 6, & 12
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Computerized assessment of various foods (for self-selected portion sizes, estimation of calorie content, and satiety value) and general knowledge about portion size
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Months 0, 3, 6, & 12
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Change in portion size consumption
Tijdsspanne: Months 0, 3, 6, & 12
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Portion sizes consumed in various food categories as assessed by diet recalls and diet records
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Months 0, 3, 6, & 12
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Change in blood biomarkers
Tijdsspanne: Months 0, 3, 6, & 12
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Fasting lipids, glucose, insulin, and calculated insulin resistance
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Months 0, 3, 6, & 12
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Change in waist circumference
Tijdsspanne: Months 0, 3, 6, & 12
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Months 0, 3, 6, & 12
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Change in blood pressure
Tijdsspanne: Months 0, 3, 6, & 12
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Months 0, 3, 6, & 12
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Change in dietary intakes
Tijdsspanne: Months 0, 3, 6, 9, & 12
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Energy intake, nutrient intakes, dietary energy density, food group intakes, and diet quality from three days of 24-hour diet recalls
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Months 0, 3, 6, 9, & 12
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Change in step counts
Tijdsspanne: Months 0, 3, 6, 9, & 12
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Daily step counts from pedometers
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Months 0, 3, 6, 9, & 12
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Change in attitudes and behaviors related to food and eating
Tijdsspanne: Months 0, 1, 3, 6, & 12
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Self-reported eating attitudes and behaviors on multiple questionnaires
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Months 0, 1, 3, 6, & 12
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Change in psychosocial characteristics
Tijdsspanne: Months 0, 3, 6, & 12
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Questionnaires measuring psychosocial characteristics including impulsivity, variety-seeking, and self-efficacy
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Months 0, 3, 6, & 12
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Intervention adherence
Tijdsspanne: Month 12
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Number of sessions attended, number of diet and activity records completed, and frequency of using intervention strategies during the entire trial
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Month 12
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Barbara J. Rolls, PhD, Penn State University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2012
Primaire voltooiing (Werkelijk)
1 maart 2015
Studie voltooiing (Werkelijk)
1 maart 2015
Studieregistratiedata
Eerst ingediend
15 november 2011
Eerst ingediend dat voldeed aan de QC-criteria
17 november 2011
Eerst geplaatst (Schatting)
18 november 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
15 mei 2015
Laatste update ingediend die voldeed aan QC-criteria
14 mei 2015
Laatst geverifieerd
1 mei 2015
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- PortionSize101
- R01DK059853 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .