Michigan Weight Navigation Program (MiWeigh) Study

NCT07465341 | Recruiting

• 2 other identifiers: HUM00264546R01DK139094-01A1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Weight loss program; Related Chronic health condition; Questionnaires; Blood draws

Outcome Measures

Primary Outcomes (1)

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

  Baseline to 12 months

Secondary Outcomes (5)

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

  Baseline, 12 months

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

  Baseline, 12 months

• Change in waist circumference from baseline to 12 months

  Baseline to 12 months

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

  Baseline to 12 months

• Change from baseline to 12 months in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)

  Baseline, 12 months

Study Arms (2)

MiWeigh

EXPERIMENTAL

Behavioral: MiWeigh

Enhanced Usual Care

ACTIVE COMPARATOR

Behavioral: Enhanced Usual Care (EUC)

Interventions

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.

MiWeigh

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ≥ 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Dina Griauzde, MD, MSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelley Stoll

CONTACT

734-232-0697; scstoll@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 11, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Time or publication, all other generated scientific data will be shared no later than the end of the award.
• 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.

Locations

US (1)