- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01474759
Portion Size Strategies for Management of Body Weight
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.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Pennsylvania
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University Park, Pennsylvania, Stany Zjednoczone, 16803
- Penn State University Laboratory for the Study of Human Ingestive Behavior
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Eksperymentalny: 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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Aktywny 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change in body weight
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change in portion size selection, perception, and knowledge
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Months 0, 3, 6, & 12
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Months 0, 3, 6, & 12
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Change in blood pressure
Ramy czasowe: Months 0, 3, 6, & 12
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Months 0, 3, 6, & 12
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Change in dietary intakes
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Barbara J. Rolls, PhD, Penn State University
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- PortionSize101
- R01DK059853 (Grant/umowa NIH USA)
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