- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01967992
Examining the Effects of Diet on Health With an Online Program
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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-
California
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San Francisco, California, 미국, 94115
- University of California, San Francisco
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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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|
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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hemoglobin A1c
기간: baseline to 16 weeks
|
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.
|
baseline to 16 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hemoglobin A1c
기간: 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.
|
baseline to 32 weeks
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Body weight
기간: baseline to 16 weeks
|
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.
|
baseline to 16 weeks
|
|
Body weight
기간: baseline to 32 weeks
|
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.
|
baseline to 32 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Rick Hecht, MD, University of California, San Francisco
- 수석 연구원: Laura R Saslow, PhD, University of Michigan
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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