Michigan Weight Navigation Program (MiWeigh) Study

Официальное название

The Michigan Weight Navigation Program (MiWeigh) Study

Обзор

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.

Вмешательства

• Поведенческое MiWeigh
  Participants will complete a baseline assessment that includes a survey, blood draw, and body measurements. Participants will be given access to a website with information on weight-loss options and have at least one visit with a doctor that has special training in obesity medicine. Prior to this visit, clinical pre-surveys and additional laboratory blood tests will be completed. During this visit, the doctor will work with the participant to develop an individualized weight-loss treatment plan.
• Поведенческое Enhanced Usual Care (EUC)
  Participants will complete assessments at baseline and 12 months that include a survey, blood draw, and body measurements, plus a survey at 6 months. Once randomized, participants will be given access to a website with information on weight-loss options and advised to see their primary care provider if a participant wishes to discuss the options.

Первичные конечные точки

• Mean change in body weight in kilograms from baseline to 12 months. [Срок оценки: Baseline to 12 months]

Вторичные конечные точки (5)

• Percentage of participants achieving ≥ 5% weight loss at 12 months [Срок оценки: Baseline, 12 months]
• Percentage of participants achieving ≥ 10% weight loss at 12 months. [Срок оценки: Baseline, 12 months]
• Change in waist circumference from baseline to 12 months [Срок оценки: Baseline to 12 months]
• Change in Body Mass Index (BMI) from baseline to 12 months [Срок оценки: Baseline to 12 months]
• Change from baseline to 12 months in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) [Срок оценки: Baseline, 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• ≥ 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)
• Dementia
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07465341 · HUM00264546 · R01DK139094-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗