Adaptation of the Diabetes Prevention Program for Primary Care
調査の概要
詳細な説明
This study will be a randomized trial of a weight control intervention, with participants recruited primarily from primary care practices at the University of Colorado. Study treatment will be delivered at the Center for Human Nutrition, an inter-disciplinary research clinic which is part of the University of Colorado School of Medicine. If needed, administrative study visits, such as for informed consent and for completion of questionnaires, may take place at offices in the Division of General Internal Medicine. Up to 200 patients will be enrolled, of which up to 125 will be provided with 6 months of high-intensity weight loss counseling. During the first 6 months, each participant will be seen for 12 counseling visits. These visits will take place at weeks 1, 2, 3, 4, 6, 8, 10, 12, 15, 18, 21, and 24. We estimate that between 10% and 20% of these patients will drop out prior to 6 months. After the first 6 months, the remaining participants will be randomly assigned to a treatment condition: Standard Maintenance or Intensified Maintenance. During months 7 to 18, individuals in the Standard Maintenance condition will receive informational handouts by mail (or e-mail) regarding weight maintenance, while those in the Intensified Maintenance condition will continue to have monthly in-person visits with the weight loss counselor ("Weight Coach").
All participants will use portion-controlled foods to replace 2 meals per day during the first 6 months of treatment and to replace 1 meal per day during months 7 to 18. Participants will purchase their own portion-controlled foods, although in-kind contributions from private industry will be sought to offset participants' food costs. The study consent form will explicitly describe estimated food costs for study participants. The cost of the meal plan, a "partial meal replacement" diet (replacement of 2 out of 3 meals per day) is not expected to increase food costs. Many participants should observe a decrease in food costs while following the meal plan.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Colorado
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Denver、Colorado、アメリカ、80220
- Center for Human Nutrition
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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:
- Age 18 to 79
- Able to give informed consent
- Able to keep a food record for 7 days prior to study entry and to complete 2 screening visits and a blood draw prior to enrollment
- Willing to attend all counseling sessions, to complete study-related assessments, and to be randomized to a treatment condition after 6 months of treatment
- Has a regular primary care physician (if referred from outside the University of Colorado system)
- Body mass index (BMI) ≥ 30 kg/m2 and < 50 kg/m2
- Elevated waist circumference (≥ 88 cm for women, ≥ 102 cm for men) + any one of the following:
- Glucose intolerance (fasting glucose ≥ 100 or non-fasting glucose ≥ 140, including type 2 diabetes); individuals taking medications for diabetes qualify automatically
- Elevated blood pressure (≥ 130/85), including hypertension (≥ 140/90); individuals taking anti-hypertensive medication qualify automatically
- Hyperlipidemia/dyslipidemia, including any of the following: hypertriglyceridemia (TG ≥ 150); low HDL cholesterol (< 40 for men, < 50 for women); or taking lipid-lowering medications
- Obstructive sleep apnea -
Exclusion Criteria:
- Medical conditions in which significant weight loss is normally contraindicated (e.g. pregnancy, congestive heart failure requiring diuretics, poorly controlled diabetes, Stage 4 or 5 chronic kidney disease, clinically evident cirrhosis, other severe internal organ disease); exceptions may be made if a referring physician documents that it is safe and appropriate for the individual to lose weight
- Treated for cancer within the past 5 years, except for basal cell or squamous cell skin cancer; exceptions may be made with written permission from a physician
- Myocardial infarction or stroke within the past 6 months
- Poorly controlled hypertension (≥ 160/100); may be re-screened when controlled
- Poorly controlled diabetes (hemoglobin A1c ≥ 10.0); may be re-screened when controlled
- Weight gain or loss of ≥ 5% of weight in the past 6 months; patients who have not been weight stable may be re-screened
- Chronic use of corticosteroids or second-generation antipsychotic medications (exceptions may be made for individuals using these medications who have been weight stable for 6 months)
- Psychiatric diagnoses likely to affect adherence to a research study protocol (e.g., poorly controlled schizophrenia, active substance abuse)
- Untreated major depression (PHQ-9 score ≥ 20)
- Pregnant or trying to become pregnant
- Social situation precluding participation in a research study (e.g., need to care for a small child or an elderly parent)
- Prior or planned bariatric surgery
- Participation in an organized weight loss program (e.g., Weight Watchers) at the time of enrollment
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ:Standard maintenance
During months 7 to 18, individuals in the Standard Maintenance condition will receive informational handouts by mail (or e-mail) regarding weight maintenance.
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Participants will receive written materials in months 7-18
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アクティブコンパレータ:Intensified Maintenance
During months 7 to 18, individuals in the Intensified Maintenance condition will continue to have monthly in-person visits with the weight loss counselor ("Weight Coach").
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Participants will continue with in-person counseling visits in months 7-18
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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 |
時間枠 |
|---|---|
|
weight change
時間枠:Weeks 1-4, 6, 8, 10, 12, 15, 18, 21, 24 & 72
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Weeks 1-4, 6, 8, 10, 12, 15, 18, 21, 24 & 72
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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change in glucose
時間枠:baseline, 6 months & 18 months
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baseline, 6 months & 18 months
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change in blood pressure
時間枠:baseline, 6 months & 18 months
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baseline, 6 months & 18 months
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change in waist circumference
時間枠:baseline, 6 months & 18 months
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baseline, 6 months & 18 months
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change in lipids
時間枠:baseline, 6 months & 18 months
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baseline, 6 months & 18 months
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change in health-related quality of life
時間枠:baseline & 18 months
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baseline & 18 months
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cost effectiveness
時間枠:18 months
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18 months
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:Adam G Tsai, MD, MSCE、University of Colorado, Denver
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 (実際)
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。