Portion Size Strategies for Management of Body Weight
2015年5月14日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
186
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Pennsylvania
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University Park、Pennsylvania、アメリカ、16803
- Penn State University Laboratory for the Study of Human Ingestive Behavior
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in body weight
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in portion size selection, perception, and knowledge
時間枠：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
時間枠：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
時間枠：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
時間枠：Months 0, 3, 6, & 12
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Months 0, 3, 6, & 12
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Change in blood pressure
時間枠：Months 0, 3, 6, & 12
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Months 0, 3, 6, & 12
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Change in dietary intakes
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Barbara J. Rolls, PhD、Penn State University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年7月1日
一次修了 (実際)
2015年3月1日
研究の完了 (実際)
2015年3月1日
試験登録日
最初に提出
2011年11月15日
QC基準を満たした最初の提出物
2011年11月17日
最初の投稿 (見積もり)
2011年11月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年5月15日
QC基準を満たした最後の更新が送信されました
2015年5月14日
最終確認日
2015年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- PortionSize101
- R01DK059853 (米国 NIH グラント/契約)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。