Feasibility Study of an Intensive Nutrition Therapy Program for Improvement of Obesity and Diabetes in a Low-income Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c reduction
研究概览
简要总结
This study is being done to better understand whether meal replacements can be an effective tool for weight loss and treatment of elevated blood sugars in people with obesity/overweight and diabetes/pre-diabetes who have a low income.
详细描述
The Medically Intensive Nutritional Therapy (MINT) program at Massachusetts General Hospital (MGH) Weight Center is a low-calorie nutrition plan that may offer a solution for those who have difficulty implementing a low-calorie dietary plan on their own. This study examines the effects of MINT on weight loss and blood sugar control specifically in a low-income population and explores potential reasons for discontinuing the program.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Body mass index (BMI) greater than or equal to 27 kg/m^2
- •HgA1C greater than or equal to 5.7 percent or fasting glucose greater than or equal to 100mg/dL within the previous 6 months
- •Low-income as defined by having a family income at or below 400 percent of the federal poverty level guidelines for 2022
排除标准
- •Current use of antihyperglycemic agents (other than metformin) or approved anti- obesity medications or plans to start such regimens over the 3 months post-study enrollment
- •HbA1c greater than or equal to 10 percent
- •Plans to pursue bariatric surgery over the 6 months post-study enrollment
- •Weight loss of greater than 5 kg within the previous 3 months
- •Current active eating disorder, with the exception of binge eating disorder
- •Severe active psychiatric disease or significant cognitive impairment deemed by investigator likely to impede adherence to piloted intervention
- •Active illicit substance abuse
- •Pregnant, breastfeeding, or considering pregnancy within the next 6 months
- •Current participation in another clinical research trial deemed by investigator to conflict with current study
结局指标
主要结局
Hemoglobin A1c reduction
时间窗: 3 months
Reduction of Hemoglobin A1c by greater than or equal to 0.5 percent
Body weight reduction
时间窗: 3 months
Reduction in body weight by greater than or equal to 5 percent
次要结局
- Program adherence(3 months)
研究者
Chika V. Anekwe, MD, MPH
Instructor in Medicine
Massachusetts General Hospital