ObesityNCT07465341
Michigan Weight Navigation Program (MiWeigh) Study
A study testing MiWeigh in people with Obesity, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- MiWeigh
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2026to 30 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- ≥ 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Shelley Stoll, MPH, 734-232-0697, scstoll@med.umich.edu
Dina Griauzde, MD, MSc
About this study
Official title: The Michigan Weight Navigation Program (MiWeigh) Study
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.
- Conditions
- Obesity
- Being tested
- MiWeigh, Enhanced Usual Care (EUC)
- Keywords
- Weight loss program, Related Chronic health condition, Questionnaires, Blood draws
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiWeighBehavioural
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. Additionally, participants will report weight weekly via text and receive periodic supportive messages via the health portal or phone call.
Enhanced Usual Care (EUC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MiWeigh | Experimental | Not described Receives: Behavioral: MiWeigh |
| Enhanced Usual Care | Active comparator | Not described Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in body weight in kilograms from baseline to 12 months.
Measured: Baseline to 12 months
Secondary outcomes (5)
Percentage of participants achieving ≥ 5% weight loss at 12 months
Based on kilograms.
Measured: Baseline, 12 months
Percentage of participants achieving ≥ 10% weight loss at 12 months.
Based on kilograms.
Measured: Baseline, 12 months
Change in waist circumference from baseline to 12 months
Based on centimeters.
Measured: Baseline to 12 months
Change in Body Mass Index (BMI) from baseline to 12 months
Measured: Baseline to 12 months
Change from baseline to 12 months in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)
Calculated from fasting plasma glucose and serum insulin levels.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start9 Apr 2026
- Primary completionSep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Griauzde, Internal Medicine, University of Michigan
- Investigators
- Dina Griauzde, MD, MSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465341
- Sponsor's protocol ID
- HUM00264546
- Other IDs
- R01DK139094-01A1
- Status last verified
- Jun 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award. Deposited data will be accessible through Deep Blue Data for at least 10 years, after which it will be appraised for continued preservation by University Library personnel.