Health TrialsbyHealthPanel

Michigan Weight Navigation Program (MiWeigh) Study

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Michigan

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Body Mass index (BMI) 30 kilogram per square meter or higher

Type 2 Diabetes

Prediabetes Mellitus

Hyperlipidemia (HLP)

Disqualifiers

≥ 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: MiWeighExperimental treatment 1 intervention
Group B: Enhanced Usual CareActive comparator 1 intervention

Trial outcomes

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

Based on kilograms.

Time frame
Baseline, 12 months
2

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

Based on kilograms.

Time frame
Baseline, 12 months
3

Change in waist circumference from baseline to 12 months

Based on centimeters.

Time frame
Baseline to 12 months
4

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

Time frame
Baseline to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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