REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 8
- 主要终点
- Percent Weight Change From Baseline
研究概览
简要总结
The goal of this project is to translate the Look AHEAD intensive lifestyle intervention for type 2 diabetes and obesity into usual care at community health centers, comparing an in-person group program (IP), a telephone conference call (TCC) group program, and referral to medical nutrition therapy (MNT), the current standard of care.
详细描述
Participants will be randomly assigned to one of three arms: MNT, IP, or TCC. Participants will be enrolled in the study for a total of three years. During those three years, participants will have 5 research visits, at baseline, where randomization occurs, 6 months, 12 months, 24 months, and 36 months. At each research visit, participants will have a lipid panel and HbA1c sample drawn, their blood pressure, weight, and height, baseline only, taken. Participants will also answer questionnaires that will address health behaviors, self-efficacy, measures of self-determination, depression, literacy and numeracy, food insecurity, health-related quality-of-life and patient satisfaction with quality of care.
For the group-based interventions, dietitians will deliver the adapted Look AHEAD lifestyle intervention. The first 14 sessions will be delivered weekly and the next 5 sessions biweekly. In the subsequent 18 months, group sessions will be delivered monthly from 6-24 months. In addition, participants will be offered up to 5 individual MNT sessions over the 2 year intervention period. At these individual visits, dietitians will address diabetes-related issues and discuss tailored goals and behaviors, based on the Look AHEAD model. Dietitians will provide ongoing feedback to participants' own PCPs about patient progress toward goals and will encourage PCPs to reinforce weight loss strategies with their patients. Each group will contain up to 12 participants with type 2 diabetes and will last 1-1.5 hours. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success.
In addition to the teaching component, participants who are taking insulin or medications that can cause hypoglycemia will self-monitor blood glucose levels at least 2 times per day and submit self-monitoring records for review each week, either by delivering them at the in-person sessions or by mailing, faxing, or emailing them to the study team. Patients on oral hypoglycemics who are not adjusting medications based on blood sugar will be instructed to do targeted monitoring to determine the effects of exercise and meals on blood glucose. The study provider at each health center will review BG records and make any needed adjustments to insulin or medication doses according to an algorithm to maintain glycemic control and prevent hypoglycemia as participants lose weight.
A trained member of the study staff will provide MNT referral participants with an educational handout emphasizing that modest weight loss (5 - 10%) via caloric restriction and gradual adoption of moderate increases in daily physical activity (equivalent to brisk walking for 30 minutes daily) is safe and effective in managing diabetes and schedule them for an appointment with a dietitian from Nutrition Services for follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of type 2 diabetes
- •Age 18 years or older
- •Overweight or obese (BMI >25 kg/m2)
- •HbA1c level 6.5<11.5%
- •Systolic blood pressure (SBP) <160 mmHg, diastolic blood pressure (DBP) <100 mmHg
- •Willing to lose 5-7% of body weight
- •Willing to increase activity to at least 175 minutes/week
- •Willing to commit to random assignment to either attend and participate in the lifestyle change program in person or on the telephone or be referred to Nutrition Services for medical nutrition therapy
- •Stable health, with no severe comorbidities that might interfere with their ability to participate in a group intervention that includes increasing activity or decreasing calories, such as severe psychiatric illness or significant heart disease
- •Ability to understand and communicate effectively in English or Spanish
- •Willing to self-monitor blood glucose
- •Willing to keep a food, exercise, and blood glucose diary
- •Have a primary care physician at MGH Chelsea, Charlestown, or Revere Health Centers, or be willing to attend sessions, in-person or by phone, and have medications adjusted by a provider based at one of those health centers with communication to the referring primary care provider
排除标准
- •Weight greater than 350 pounds
- •Pregnant or planning pregnancy in the next year
- •Currently seeing a dietitian (regular scheduled follow up appointments) or participating in a weight loss program and unwilling to stop
- •Weight change of more than 3% of weight in the previous month.
- •Currently enrolled in another diabetes intervention study
- •Lack of availability of telephone
结局指标
主要结局
Percent Weight Change From Baseline
时间窗: Baseline, 6, 12, 24, and 36 months.
Percent weight change form baseline; negative values indicate weight loss.
次要结局
- Hemoglobin A1c: Change From Baseline(6, 12, 24 months)
- Triglyceride Levels: Change From Baseline(6, 12, 24 months)
- Dietary Restraint: Change From Baseline(Baseline, 6, 12, 24, and 36 months.)
- Diabetes Distress: Change From Baseline(Baseline, 6, 12, 24, and 36 months.)
- Systolic Blood Pressure: Change From Baseline(6, 12, 24, months.)
- Diet Self-efficacy: Change From Baseline(6, 12, 24, and 36 months.)
- Fat-related Diet Behavior: Change From Baseline.(Baseline, 6, 12, 24, and 36 months.)
- Depression Score: Change From Baseline.(Baseline, 6, 12, 24, and 36 months.)
研究者
Linda M. Delahanty
Chief Dietitian at Massachusetts General Hospital Diabetes Center
Massachusetts General Hospital