Portion Size Strategies for Management of Body Weight
14 maj 2015 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
186
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Pennsylvania
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University Park, Pennsylvania, Förenta staterna, 16803
- Penn State University Laboratory for the Study of Human Ingestive Behavior
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: 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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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in body weight
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in portion size selection, perception, and knowledge
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Months 0, 3, 6, & 12
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Months 0, 3, 6, & 12
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Change in blood pressure
Tidsram: Months 0, 3, 6, & 12
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Months 0, 3, 6, & 12
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Change in dietary intakes
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Barbara J. Rolls, PhD, Penn State University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2012
Primärt slutförande (Faktisk)
1 mars 2015
Avslutad studie (Faktisk)
1 mars 2015
Studieregistreringsdatum
Först inskickad
15 november 2011
Först inskickad som uppfyllde QC-kriterierna
17 november 2011
Första postat (Uppskatta)
18 november 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
15 maj 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 maj 2015
Senast verifierad
1 maj 2015
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- PortionSize101
- R01DK059853 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .