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NCT Number: NCT07465341

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.

Recruiting

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Dina Griauzde, MD, MSc

PRINCIPAL_INVESTIGATOR

Shelley Stoll, MPH

CONTACT

[email protected]

734-232-0697

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MiWeigh

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Mean change in body weight in kilograms from baseline to 12 months.

    Time frame: Baseline to 12 months

Secondary outcomes

  1. Percentage of participants achieving ≥ 5% weight loss at 12 months

    Time frame: Baseline, 12 months

    Based on kilograms.

  2. Percentage of participants achieving ≥ 10% weight loss at 12 months.

    Time frame: Baseline, 12 months

    Based on kilograms.

  3. Change in waist circumference from baseline to 12 months

    Time frame: Baseline to 12 months

    Based on centimeters.

  4. Change in Body Mass Index (BMI) from baseline to 12 months

    Time frame: Baseline to 12 months

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shelley Stoll

CONTACT

[email protected]

734-232-0697

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

The Michigan Weight Navigation Program (MiWeigh) Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 11, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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