Michigan Weight Navigation Program (MiWeigh) to help adults with obesity lose weight
The Michigan Weight Navigation Program (MiWeigh) Study
This project tests whether adults with obesity and at least one related health condition lose more weight using the MiWeigh program than by receiving information about weight-loss strategies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07465341 on ClinicalTrials.gov |
What this trial studies
Adults with BMI ≥30 and one or more weight-related conditions are randomized to the MiWeigh intervention or to enhanced usual care. The MiWeigh arm receives a combination of virtual provider visits, regular messaging through the electronic health record portal, and weekly weight reporting by text, while both arms complete questionnaires and periodic blood draws. The study tracks weight change over time and includes process measures to determine which program components work and why. If effective, the protocol is intended to inform how other health systems could implement similar weight-navigation services.
Who should consider this trial
Good fit: Adults with BMI ≥30 who have at least one weight-related condition (for example type 2 diabetes, prediabetes, hyperlipidemia, hypertension, PCOS, OSA, or MASLD), speak English, are interested in losing weight, and can use the patient portal, text weekly, and attend virtual visits.
Not a fit: Patients who recently lost ≥5% body weight in the past year, are pregnant or planning pregnancy or breastfeeding, have already participated in a weight-navigation visit, or are actively enrolled in another weight-loss program are unlikely to benefit from or be eligible for this program.
Why it matters
Potential benefit: If successful, MiWeigh could help patients with obesity and related conditions achieve clinically meaningful weight loss and improve related health measures.
How similar studies have performed: Previous clinic-based and remote weight-management and navigation programs have produced modest but meaningful weight loss in prior trials, though specific program designs and results vary.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Dina Griauzde, MD, MSc — University of Michigan
- Study coordinator: Shelley Stoll
- Email: scstoll@med.umich.edu
- Phone: 734-232-0697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.