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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK059853 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portion size instruction | Experimental | Advice on diet, physical activity, and behavior change. Instruction in food portion size. |
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| Pre-portioned foods | Experimental | Advice on diet, physical activity, and behavior change. Provision of pre-portioned foods. |
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| Comparison | Active Comparator | Advice on diet, physical activity, and behavior change. Advice on healthy eating for weight loss. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advice on diet, physical activity, and behavior change | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in portion size selection, perception, and knowledge | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J. Rolls, PhD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University Laboratory for the Study of Human Ingestive Behavior | University Park | Pennsylvania | 16803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32234531 | Derived | 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. | |
| 28442337 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| D015444 | Exercise |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Instruction in food portion size | Behavioral | 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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| Provision of pre-portioned foods | Other | 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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| Advice on healthy eating for weight loss | Behavioral | 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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Portion sizes consumed in various food categories as assessed by diet recalls and diet records |
| Months 0, 3, 6, & 12 |
| Change in blood biomarkers | Fasting lipids, glucose, insulin, and calculated insulin resistance | Months 0, 3, 6, & 12 |
| Change in waist circumference | Months 0, 3, 6, & 12 |
| Change in blood pressure | Months 0, 3, 6, & 12 |
| Change in dietary intakes | 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 | Daily step counts from pedometers | Months 0, 3, 6, 9, & 12 |
| Change in attitudes and behaviors related to food and eating | Self-reported eating attitudes and behaviors on multiple questionnaires | Months 0, 1, 3, 6, & 12 |
| Change in psychosocial characteristics | Questionnaires measuring psychosocial characteristics including impulsivity, variety-seeking, and self-efficacy | Months 0, 3, 6, & 12 |
| Intervention adherence | Number of sessions attended, number of diet and activity records completed, and frequency of using intervention strategies during the entire trial | Month 12 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |