NCT07465341招募中不适用
The Michigan Weight Navigation Program (MiWeigh) Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Mean change in body weight in kilograms from baseline to 12 months.
研究概览
简要总结
The main purpose of this study is to determine whether people who participate in MiWeigh lose more weight than people who receive information about weight loss strategies and programs. The researchers also want to learn what parts of the program do and do not work and why. If the program is effective, the researchers want to learn how other health care systems could offer this program.
The overarching aim of the MiWeigh Study is to better help patients prevent, manage, or reverse obesity-related chronic conditions.
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)
盲法说明
Outcome assessors will be blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass index (BMI) 30 kilogram per square meter or higher
- •Diagnosed with one or more of the following weight-related conditions:
- •Type 2 Diabetes
- •Prediabetes Mellitus
- •Hyperlipidemia (HLP)
- •Hypertension (HTN)
- •Polycystic Ovary Syndrome (PCOS)
- •Obstructive Sleep Apnea (OSA) and/or
- •Metabolic dysfunction-associated steatotic liver disease (MASLD)
- •Speaks English
- •Interest in losing weight
- •Willingness to complete assessments per study protocol
- •Willing and able to use the Electronic health records patient portal to respond to messages
- •Willing to report weight weekly by text if randomized to intervention arm
- •Able to see provider virtually at certain days/times up to four times in a year
排除标准
- •≥ 5% weight loss within the prior 12 months
- •Has had a Weight Navigation Program visit in past
- •Pregnant, planning a pregnancy, or breastfeeding in the next year
- •Ongoing participation in another weight-loss program
- •Taking an anti-obesity medication
- •Ever diagnosed with Type 1 Diabetes Mellitus (per protocol)
- •Serious uncontrolled mental health conditions as indicated (per protocol)
- •Chronic kidney disease, Stage 4 or higher
- •Alcohol dependence and opioid dependence (per protocol)
- •History of anorexia or bulimia
- •Bariatric/ gastric bypass surgery, gastric sleeve surgery, or gastric balloon procedure in last year
- •Currently enrolled in an interventional research study that is examining how a diet, program, or drug might: promote physical exercise, healthy eating habits, or weight loss; lower blood pressure; or lower blood sugar
- •Not planning to live in local area over the next year
- •Intensive cancer treatment such as bone marrow transplant, chemotherapy, radiation, or cancer related surgery (not including hormonal chemotherapy like Tamoxifen) in last six months or next 12 months
- •Other serious health issues or personal concerns that could prevent participant from completing study
研究组 & 干预措施
MiWeigh
Experimental
干预措施: MiWeigh (Behavioral)
Enhanced Usual Care
Active Comparator
干预措施: Enhanced Usual Care (EUC) (Behavioral)
结局指标
主要结局
Mean change in body weight in kilograms from baseline to 12 months.
时间窗: Baseline to 12 months
次要结局
- Percentage of participants achieving ≥ 5% weight loss at 12 months(Baseline, 12 months)
- Percentage of participants achieving ≥ 10% weight loss at 12 months.(Baseline, 12 months)
- Change in waist circumference from baseline to 12 months(Baseline to 12 months)
- Change in Body Mass Index (BMI) from baseline to 12 months(Baseline to 12 months)
- Change from baseline to 12 months in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)(Baseline, 12 months)
研究者
Dina Griauzde, Internal Medicine
Assistant Professor of Internal Medicine
University of Michigan
研究点 (1)
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