Examining the Effects of Diet on Health With an Online Program
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94115
- University of California, San Francisco
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- HbA1c 6.5%-9% at screening.
- Aged 18 years old and older
- BMI 25 and above.
- Willing and able to participate in the interventions such as having sufficient control over their food intake. Must have the ability to make choices about the food they eat; cannot have a lifestyle in which they eat out most of their meals.)
Exclusion Criteria:
- Unable to provide informed consent.
- Non English speaker.
- No current use of insulin, no immediate plans to start or increase diabetic mediations, and no use of diabetes medications besides metformin.
- A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention. Such conditions may include: cancer, liver failure, unstable coronary artery disease, severe emphysema, binge eating disorder or history of binge eating disorder, bulimia or strong history of bulimia.
- Previous use or recent changes in medications that can interfere with the measures used in the study: current use of insulin; use of systemic (oral or IV) corticosteroids in the 6 months prior to enrollment or severe autoimmune disorders or other conditions (e.g. rheumatoid arthritis, lupus), that are likely to require these medications; and initiation of new class of psychiatric medications in past 2 months.
- Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum.
- Current use of weight loss medications or supplements such as Alli or amphetamine-based drugs that are believed to have some effect on weight.
- History of or planned weight loss surgery.
- Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants.
- No or very limited internet access at a computer. Must be able to complete the online assessments and access the online class materials.
研究計画
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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アクティブコンパレータ:American Diabetes Association recommended diet
Participants in the American Diabetes Association (ADA) diet group will receive standard ADA advice.
The diet includes high-fiber foods (such as vegetables, fruits, whole grains, and legumes), low-fat dairy products, fresh fish, and foods low in saturated fat.
They will be asked to use the "plate method" to guide their nutritional choices.
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実験的:Low Carbohydrate Diet
Participants will be instructed to follow a low carbohydrate, ketogenic diet: carbohydrate intake 20-35 grams a day not including fiber. Foods permitted include: meats, poultry, fish, eggs, cheese, cream, some nuts and seeds, green leafy vegetables, and most other non-starchy vegetables. Because most individuals self-limit caloric intake, no calorie restriction will be recommended. Participants will also be taught information about mindfulness and positive affect practices. The mindfulness-based curriculum will focus on the following elements: training on topics such as mindful meditation, mindful eating, awareness of fullness and hunger signals, and taste satiety. The positive emotion curriculum will include: training on topics such as noticing and savoring positive events, gratitude, positive reappraisal, personal strengths, attainable goals, and acts of kindness. |
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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Hemoglobin A1c
時間枠:baseline to 16 weeks
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We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks.
The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 16 weeks.
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baseline to 16 weeks
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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 |
|---|---|---|
|
Hemoglobin A1c
時間枠:baseline to 32 weeks
|
We will test whether Hemoglobin A1c changes from pre-intervention to 32 weeks.
The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 32 weeks.
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baseline to 32 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Body weight
時間枠:baseline to 16 weeks
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We will test whether body weight changes from pre-intervention to 16 weeks.
The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 16 weeks.
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baseline to 16 weeks
|
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Body weight
時間枠:baseline to 32 weeks
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We will test whether body weight changes from pre-intervention to 32 weeks.
The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 32 weeks.
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baseline to 32 weeks
|
協力者と研究者
捜査官
- 主任研究者:Rick Hecht, MD、University of California, San Francisco
- 主任研究者:Laura R Saslow, PhD、University of Michigan
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。
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