Michigan Weight Navigation Program (MiWeigh) Study
Recruiting · NCT07465341 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Michigan
View the official record on ClinicalTrials.gov →Interventions studied
Enhanced Usual Care (EUC)MiWeigh
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- ≥ 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
Where it is running
1 location listed across 1 US state.
- University of Michigan - Ann Arbor, Michigan, United States