- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03258918
A Low-Carbohydrate Diabetes Prevention Program
A Mixed Methods Pilot Study of a Low-Carbohydrate Diabetes Prevention Program Among Individuals With Prediabetes
연구 개요
상세 설명
An estimated 86 million US adults are have prediabetes, and, without intervention, many will develop T2DM over time. Fortunately, T2DM can be prevented or delayed through modest lifestyle changes. The landmark Diabetes Prevention Program (DPP) Trial demonstrated a 58 percent reduction in the 3-year incidence of T2DM among individuals with prediabetes who achieved 7 percent body weight loss and engaged in routine physical activity. Accordingly, the DPP lifestyle intervention has been translated to communities across the United States, and, on average, participant weight change is 4 percent at 12 months. Thus, while group-based DPPs and can effectively promote weight loss among some participants, many DPP participants do not achieve the program goal of 5 to 7 percent body weight loss.
Novel strategies to help participants achieve DPP weight-loss goals are important for two key reasons. First, weight loss is the primary driver of T2DM risk reduction, and the potential population health impact of the intervention is diminished when participants do not lose weight. Second, a growing number of health plans including Medicare offer coverage for the DPP and proposed reimbursement is largely tied to weight loss of at least 5 percent at 6 months and 12 months. The DPP costs approximately $400-$500 per participant per year. Unfortunately, organizations that offer the DPP may be reimbursed for much less than this if participants do not meet weight loss goals, which could significantly compromise the program's long-term financial sustainability.
One promising approach to help DPP participants lose more weight may be through a low-carbohydrate (LC) dietary intervention. Consistent with United States Dietary Guidelines (USDG), the original DPP Trial and translational group-based curricula recommend a low-fat (LF), calorie-restricted diet. However, there is growing controversy regarding the scientific merit of the Dietary Guidelines as well as growing recognition that LC diets may be more effective than LF diets for short-term weight loss and long-term weight maintenance. Notably, weight loss occurs without calorie restriction and LC diets improve blood glucose levels among individuals with T2DM and insulin resistance. Thus, a LC dietary intervention for prediabetes may augment individual weight loss and T2DM risk reduction while also maximizing third-party reimbursement.
The aim of this mixed methods pilot study is to test whether a LC-DPP may lead to greater weight loss than the original DPP. In addition to objective measures of this program's preliminary efficacy (e.g. weight, HbA1c) the study team will also obtain qualitative participant feedback on the intervention. Taken together, these data will be used to improve the curriculum and inform a larger-scale intervention.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- Michigan Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- Overweight, defined as BMI≥25 kg/m2 [31]
- HbA1c between 5.7-6.4% drawn within 6 months of the study start date
- Willingness to participate in group-based classes
- Able to engage in at least light physical activities such as walking.
Exclusion criteria:
- History of type 1 diabetes or type 2 diabetes
- Current participation in another lifestyle or behavior change program or research study
- Vegetarian or vegan lifestyle
- History of bariatric surgery
- Inability to read, write, or speak English
- Inability to provide informed consent
- Women who are pregnant or intend to become pregnant during the intervention period.
- Insured by Premier Care or Grad Care; these individuals have the opportunity to participate in a standard DPP, which is offered as a covered benefit through their health plan.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Low-Carbohydrate Diabetes Prevention Program
At least 20 individuals with prediabetes will participate in a year-long , group-based program.
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LC-DPP participants will be instructed to follow ad-libitum very low-carbohydrate, ketogenic diet, which restricts carbohydrate intake (not including fiber) to 20-35 grams per day with the goal of achieving nutritional ketosis.
Participants will be encouraged to eat a normal amount of protein (roughly 80-120 grams per day) and to derive the remaining calories from fat.
Allowable foods include: meats, fish, poultry, eggs, cheese, seeds, nuts, leafy greens, non-starchy vegetables, and some fruits.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in body weight per participant over the study period
기간: Baseline, 12 months
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Measured as percent body weight loss per participant
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Baseline, 12 months
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Percentage of participants who achieve weight loss goal
기간: Baseline,12 months
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Measured as percentange of participants who achieve 5% total body weight loss
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Baseline,12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in self-reported weekly physical activity minutes
기간: Baseline, 12 months
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Participants will maintain a log of weekly physical activity minutes
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Baseline, 12 months
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Change in physical activity measured using the International Physical Activity Questionnaire
기간: Baseline, 12 months
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Participants will complete this validated survey
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Baseline, 12 months
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Change in food cravings measured using the Control of Eating Questionnaire
기간: Baseline, 12 months
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Participants will complete this validated survey
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Baseline, 12 months
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Change in stress eating measured using the Palatable Eating Motives Scale
기간: Baseline, 12 months
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Participants will complete this validated survey
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Baseline, 12 months
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Change in self-reported health measured using the Global Health PROMIS Questionnaire
기간: Baseline, 12 months
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Participants will complete this validated survey
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Baseline, 12 months
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Change in autonomous motivation measured using the Treatment Self-Regulation Questionnaire
기간: Baseline, 12 months
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Participants will complete this validated survey
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Baseline, 12 months
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Change in hemoglobin A1c
기간: Baseline, 12 months
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Measured using a laboratory blood draw
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Baseline, 12 months
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Session attendance
기간: Baseline, 12 months
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Measured as the number of sessions attended per participant
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Baseline, 12 months
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Study attrition
기간: Baseline, 12 months
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Number of participants lost to follow-up
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Baseline, 12 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in diet as assessed by qualitative review of foods logs
기간: Baseline, 12 months
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Participants will maintain weekly food logs
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Baseline, 12 months
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Change in diet as assessed by response to survey questions
기간: Baseline, 12 months
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Participants will respond to exploratory survey questions about diet created by the study team.
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Baseline, 12 months
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Change in physical symptoms
기간: Baseline, 12 months
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Participants will respond to exploratory survey questions about physical symptoms created by the study team.
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Baseline, 12 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
당뇨병 전증에 대한 임상 시험
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US Department of Veterans AffairsUniversity of Maryland; National Institutes of Health (NIH); National Institute on Aging...완전한
Low-Carbohydrate Diabetes Prevention Program에 대한 임상 시험
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University of Texas Southwestern Medical CenterNational Institute on Minority Health and Health Disparities (NIMHD)초대로 등록