Portion Size Strategies for Management of Body Weight
14 mai 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
186
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Pennsylvania
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University Park, Pennsylvania, États-Unis, 16803
- Penn State University Laboratory for the Study of Human Ingestive Behavior
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in body weight
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in portion size selection, perception, and knowledge
Délai: 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
Délai: 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
Délai: 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
Délai: Months 0, 3, 6, & 12
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Months 0, 3, 6, & 12
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Change in blood pressure
Délai: Months 0, 3, 6, & 12
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Months 0, 3, 6, & 12
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Change in dietary intakes
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Barbara J. Rolls, PhD, Penn State University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juillet 2012
Achèvement primaire (Réel)
1 mars 2015
Achèvement de l'étude (Réel)
1 mars 2015
Dates d'inscription aux études
Première soumission
15 novembre 2011
Première soumission répondant aux critères de contrôle qualité
17 novembre 2011
Première publication (Estimation)
18 novembre 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
15 mai 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 mai 2015
Dernière vérification
1 mai 2015
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- PortionSize101
- R01DK059853 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .