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Recruiting NCT07465341

Michigan Weight Navigation Program (MiWeigh) Study

No phase Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MiWeigh, Enhanced Usual Care (EUC).
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Michigan Weight Navigation Program (MiWeigh) Study

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Mean change in body weight in kilograms from baseline to 12 months. [Time frame: Baseline to 12 months]
Secondary outcome measures (5)
  • Percentage of participants achieving ≥ 5% weight loss at 12 months [Time frame: Baseline, 12 months]
  • Percentage of participants achieving ≥ 10% weight loss at 12 months. [Time frame: Baseline, 12 months]
  • Change in waist circumference from baseline to 12 months [Time frame: Baseline to 12 months]
  • Change in Body Mass Index (BMI) from baseline to 12 months [Time frame: Baseline to 12 months]
  • Change from baseline to 12 months in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) [Time frame: Baseline, 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT07465341 · HUM00264546 · R01DK139094-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗