NCT01636258已完成不适用
Diet, Exercise, Cooking, and Stress Management for Patients With Prediabetes: A Pilot Randomized Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Effect of "FRESH" Program on Weight Loss
研究概览
简要总结
To examine whether a lifestyle program results in weight loss and thereby delays or prevents progression of pre-diabetes to diabetes, we propose a pilot randomized controlled trial of 6 weeks duration with 30 participants held at Stephanie Tubbs Jones Health Center. Participants are randomized to receive all of the following: nutrition education, exercise instruction, stress management instruction, and culinary education or follow usual care. Outcomes include: blood sugars and cholesterol, weight, waist circumference, blood pressure, diet, physical activity, perceived stress, and class attendance. Analysis is by Intention to treat analysis of variance. Results will be used to help design larger randomized trial in the future.
详细描述
Control group:
These participants will continue to receive their usual care from their primary medical care team.
Intervention group:
The participants will receive nutrition education, exercise instruction, stress management instruction,and culinary education
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Study participants must:
- •Be capable of giving informed consent
- •Understand and voluntarily sign the informed consent form.
- •Be females at least 18 years of age and identify themselves as African-American
- •Have prediabetes as defined by the American Diabetes Association: history of glycated hemoglobin (HgbA1c) 5.7-6.4 % or fasting blood glucose 100-125 mg/dL (5.6-6.9 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose 140-199 mg/dL (7.8-11.0 mmol/L) during an oral glucose tolerance test (as described by the World Health Organization using a glucose load of 75 g anhydrous glucose dissolved in water)
- •Have a body mass index (BMI, defined as weight in kilograms divided by height in meters squared) greater than or equal to 25
排除标准
- •Current or previous diagnosis of diabetes or a history of HgbA1c ≥ 6.5% or fasting blood glucose ≥ 126 mg/dL (7.0 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test or a history of classic symptoms of hyperglycemia or hyperglycemic crisis and a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L).
- •Normal glycemia or a currently with a HgbA1c < 5.7% or fasting blood glucose < 100 mg/dL (7.0 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose < 140 mg/dL (11.1 mmol/L) during an oral glucose tolerance test
- •Current or past use of oral hypoglycemic agents (including, but not limited to, metformin, rosiglitazone, pioglitazone, glipizide, and glyburide) or insulin
- •Male gender
- •History of congestive heart failure
- •History of renal failure, dialysis, or creatinine greater than 2 mg/dL
- •History of liver failure or a liver dysfunction with a increase by a factor of 2 above the upper limit of normal in alanine aminotransferase or aspartate aminotransferase
- •History of gastrointestinal disorder that would prevent adherence to the recommended diet (e.g. celiac disease, inflammatory bowel disease, history of bariatric surgery, history of intestinal surgery)
- •Presence of active cancer
- •History of coronary artery disease or cerebrovascular disease
- •History of uncontrolled hypertension
- •Participation in another lifestyle modification trial
- •Pregnancy or lactating or planning to be pregnant
- •Current alcoholism or abuse of recreational drugs
- •Hospitalization for depression in past 12 months
- •Travel plans that do not permit full participation or participant lives too far from Health Center to permit full participation
- •History of bariatric surgery, small bowel resection, or extensive bowel resection
- •Chronic treatment with systemic steroids
- •Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- •Inability to walk two blocks
- •Other medial, psychiatric, or behavioral limitations that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol
- •Amputation of lower limb for nontraumatic causes
- •Self report of HIV-positivity or active tuberculosis
- •Documented history of pulmonary embolus in past six months
- •Chronic obstructive pulmonary disease that would limit ability to follow the study protocol
- •Self-reported chronic hepatitis B or C or cirrhosis; inflammatory bowel disease requiring treatment in past year; Cushing's syndrome; acromegaly (clinical diagnosis or self-report); any major organ transplant
- •Unwilling or uninterested in participating in group lifestyle education sessions
- •Current regular corticosteroid use
- •Active polycystic ovarian syndrome
结局指标
主要结局
Effect of "FRESH" Program on Weight Loss
时间窗: Baseline line and final followup visit (at 8-14 weeks)
Change in weight measured at baseline and followup (at 8-14 weeks).
次要结局
- Diet - Daily Calorie Intake(Baseline and final followup visit (at 8-14 weeks))
- Stress(baseline and followup visit (at 8-14 weeks))
- Sleep(baseline and followup visit (at 8-14 weeks))
- Exercise(Baseline and final followup visits (at 8-14 weeks))
研究者
Linda Libertini
Research Coordinator
The Cleveland Clinic
研究点 (2)
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