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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK139094-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MiWeigh | Experimental |
| |
| Enhanced Usual Care | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in body weight in kilograms from baseline to 12 months. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving ≥ 5% weight loss at 12 months | Based on kilograms. | Baseline, 12 months |
| Percentage of participants achieving ≥ 10% weight loss at 12 months. | Based on kilograms. |
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Inclusion Criteria:
Body Mass index (BMI) 30 kilogram per square meter or higher
Diagnosed with one or more of the following weight-related conditions:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shelley Stoll | Contact | 734-232-0697 | scstoll@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dina Griauzde, MD, MSc | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award. Deposited data will be accessible through Deep Blue Data for at least 10 years, after which it will be appraised for continued preservation by University Library personnel.
Time or publication, all other generated scientific data will be shared no later than the end of the award.
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.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Outcome assessors will be blinded.
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| 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. |
|
| Baseline, 12 months |
| Change in waist circumference from baseline to 12 months | Based on centimeters. | 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) | Calculated from fasting plasma glucose and serum insulin levels. | Baseline, 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |