Michigan Weight Navigation Program (MiWeigh) Study

April 24, 2026 updated by: Dina Griauzde, Internal Medicine, University of Michigan

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Dina Griauzde, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enhanced Usual Care
Behavioral: 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.
Experimental: MiWeigh
Behavioral: 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. Additionally, participants will report weight weekly via text and receive periodic supportive messages via the health portal or phone call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in body weight in kilograms from baseline to 12 months.
Time Frame: Baseline to 12 months
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving ≥ 5% weight loss at 12 months
Time Frame: Baseline, 12 months
Based on kilograms.
Baseline, 12 months
Percentage of participants achieving ≥ 10% weight loss at 12 months.
Time Frame: Baseline, 12 months
Based on kilograms.
Baseline, 12 months
Change in waist circumference from baseline to 12 months
Time Frame: Baseline to 12 months
Based on centimeters.
Baseline to 12 months
Change in Body Mass Index (BMI) from baseline to 12 months
Time Frame: Baseline to 12 months
Baseline to 12 months
Change from baseline to 12 months in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)
Time Frame: Baseline, 12 months
Calculated from fasting plasma glucose and serum insulin levels.
Baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Dina Griauzde, MD, MSc, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2026

Primary Completion (Estimated)

April 1, 2031

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00264546
  • R01DK139094-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Time or publication, all other generated scientific data will be shared no later than the end of the award.

IPD Sharing Access Criteria

All data collected in this project will be made available to the scientific community. During deposit into Deep Blue Data, researchers include documentation for the data and assign metadata to the data to facilitate its discovery and use. The metadata can be harvested by search engines such as Google Dataset Search. Datasets are assigned a Digital Object Identifier (DOI) as a persistent identifier, enabling the data to be cited in publications. Researchers select a Creative Commons or other open license as a part of the deposit process to describe the conditions under which others may use the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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