RecruitingNot ApplicableNCT07465341

Michigan Weight Navigation Program (MiWeigh) Study

The Michigan Weight Navigation Program (MiWeigh) Study

Sponsor

University of Michigan

Enrollment

500 participants

Start Date

Apr 9, 2026

Study Type

INTERVENTIONAL

Conditions

Obesity

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. 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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria15

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 Criteria16

≥ 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

Interested in this trial?

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Interventions

BEHAVIORALMiWeigh

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.

BEHAVIORALEnhanced 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.