Data-Assisted Approach for High Intensity Medical Weight Loss for Diabetes Remission
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in Body Weight
研究概览
简要总结
The study team will study the efficacy of a high intensity medical weight loss intervention paired with a digital platform to create weight loss and induce remission of type 2 diabetes mellitus (T2DM) compared to a diabetes self-management education intervention. The digital platform provides the capability to tailor the treatment plan, provide automated support, and alert providers when a participant may need more support from the clinical team. If shown to be efficacious, this research could be highly impactful, causing us to rethink our approach to care for those with T2DM and shift the paradigm for millions of individuals in the United States. Furthermore, this approach will demonstrate the feasibility of helping people engage in metabolic treatment strategies in a way that is scalable leveraging digital and mobile solutions that extend the patient-provider relationship, shift care from episodic approaches to more of an on-going model that extends into the life of the patient, while also integrated within the healthcare system workflows.
详细描述
This project will determine if a data-assisted, high intensity medical weight loss intervention (HIWL) will lead to significant weight loss and diabetes remission in individuals with a Body Mass Index (BMI) 30-39.9 kg/m2 with T2DM of less than 6 years as compared to a diabetes self-management education intervention (DSME). Complete diabetes remission is considered to be achieved when the patient is not taking any anti-diabetes medication for at least 12 months, and the Glycated Hemoglobin (HbA1c) is < 5.7%. Partial remission is achieved when the patient is not taking any anti-diabetes medication and has an HbA1c of 5.7-6.4% for at least 12 months.Using a randomized controlled study design, we will randomly assign 90 participants to HIWL, HIWL + continuous glucose monitoring (CGM), or DSME. Participants assigned to HIWL will receive a high intensity behavioral weight loss intervention delivered using a digital patient engagement platform. Participants will be prescribed a low calorie dietary plan and a recommended physical activity program designed to produce 15-20% weight loss over 12 months. Those assigned to HIWL + CGM will receive the same intervention as HIWL; in addition we will provide them with CGM to use as part of their remote monitoring on a daily basis. Those assigned to DSME will participate in a comprehensive diabetes education program designed to provide education and skills for optimal diabetes management plus lifestyle modification counseling to produce 5% weight loss over the same timeframe. The primary outcome of weight loss will be assessed at 12 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with T2DM diagnosed within the past 6 years
- •Body Mass Index (BMI) of 30-39.9 kg/m
- •Participants must have an HbA1c between 6.5-11.9%.
- •Participants should be able to participate in all aspects of the recommended interventions, including being able to participate in exercise, make recommended dietary changes, and engage in individual and group counseling.
排除标准
- •Poorly controlled depression
- •Recent hospitalization for psychosis or bipolar disorder
- •Poorly controlled blood pressure (>159/99)
- •Prior surgical procedure for weight control or liposuction
- •Unable to make changes to their diet
- •Unable to exercise (walk for at least 6 minutes and perform simple strength and stretch exercise tests)
- •Use of weight loss medications in previous 3 months
- •Recent self-reported weight change (+/- 15lbs)
- •Current use of oral corticosteroids more than 5days/month
- •Cardiovascular disease event within the past 6 months
- •Severe pulmonary disease requiring supplemental oxygen
- •Renal failure (end stage renal disease)
- •History of non-skin cancer in the past 5 years
- •Major liver dysfunction within the last 2 years
- •Recently quit smoking less than 6 months prior
- •Inability to attend visits and adhere to study protocols
- •Pregnancy or currently lactating
研究组 & 干预措施
Diabetes self-management education (DSME)
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
干预措施: Diabetes education (Behavioral)
High intensity medical weight loss (HIWL)
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
干预措施: Medical weight loss (Behavioral)
High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM)
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
干预措施: Medical weight loss (Behavioral)
High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM)
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
干预措施: Continuous glucose monitoring (Behavioral)
结局指标
主要结局
Change in Body Weight
时间窗: baseline through 12 months
Change in weight from baseline
次要结局
- Continuous Glucose Monitor - Episodes of Hypoglycemia(baseline and month 12)
- Continuous Glucose Monitoring (CGM) Time in Range(baseline and month 12)
- Continuous Glucose Monitoring Time in Range--Post-meal Glucose(baseline through 12 months)
- Continuous Glucose Monitor Time in Range--Fasting Glucose(baseline through 12 months)
- Continuous Glucose Monitor - Glucose Variability(baseline and month 12)
- Continuous Glucose Monitoring - Average Glucose(baseline and 12 months)
- ASA24 Healthy Eating Index (HEI)-2015 Score(baseline, 3 months, 6 months, and 12 months)
- Change in Quality of Life(from baseline to month 12)
- Change in Perceived Health Rating(from baseline to month 12)
- ASA24 Healthy Eating Index (HEI)-2015 score(baseline, 3 months, 6 months, and 12 months)
- Continuous Glucose Monitoring (CGM) Time in Range(baseline through 12 months)
- CGM Time in Range--Fasting Glucose(baseline through 12 months)
- ASA24 Number of Eating Episodes Per Day(baseline, 3 months, 6 months, and 12 months)
- Daily Step Counts(baseline, 3 months, 6 months, and 12 months)
- CGM Average Glucose(baseline through 12 months)
- Number of Subjects in Diabetes Remission(12 months)
- CGM Episodes of Hypoglycemia(baseline through 12 months)
- CGM Glucose Variability(baseline through 12 months)
- Automated Self-Administered 24-hour (ASA24) Total Daily Energy Intake(baseline, 3 months, 6 months, and 12 months)
- International Physical Activity Questionnaire (IPAC) short form: moderate-vigorous physical activity minutes(baseline, 3 months, 6 months, and 12 months)
- Change in Hemoglobin A1c(baseline through 12 months)
- CGM Time in Range--Post-meal Glucose(baseline through 12 months)
- ASA24 Macronutrient Composition of Diet(baseline, 3 months, 6 months, and 12 months)
- International Physical Activity Questionnaire (IPAC) short form: sitting time(baseline, 3 months, 6 months, and 12 months)
- International Physical Activity Questionnaire (IPAC) short form: walking minutes(baseline, 3 months, 6 months, and 12 months)