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The goal of the research is to optimize an online and mobile multicomponent 12-month diet and lifestyle intervention for improving the blood glucose control of individuals with type 2 diabetes.
The research will identify the most promising intervention components. The following components will be tested: dietary adherence testing with a breath meter, text messages, and diet-appropriate foods and cookbooks. The primary goal is to optimize the intervention by examining the HbA1c results at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Condition 1 | Experimental | 1) core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks |
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| Experimental: Condition 2 | Experimental | 1) core program |
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| Experimental: Condition 3 | Experimental | 1) core program; 2) breath meter |
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| Experimental: Condition 4 | Experimental | 1) core program; 2) text messages |
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| Experimental: Condition 5 | Experimental | 1) core program; 2) diet-appropriate food and cookbooks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent online program | Behavioral | The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Change in HbA1c from baseline to 12 months post baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight Percent Lost | Change in body weight percentage from baseline to 12 months post baseline | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Saslow, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32902391 | Background | Saslow LR, Moskowitz JT, Mason AE, Daubenmier J, Liestenfeltz B, Missel AL, Bayandorian H, Aikens JE, Kim S, Hecht FM. Intervention Enhancement Strategies Among Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Evaluating the Impact With a Randomized Trial. JMIR Diabetes. 2020 Sep 9;5(3):e15835. doi: 10.2196/15835. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Experimental: Condition 6 | Experimental | 1) core program; 2) breath meter; 3) text messages |
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| Experimental: Condition 7 | Experimental | 1) core program; 2) breath meter; 3) diet-appropriate food and cookbooks |
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| Experimental: Condition 8 | Experimental | 1) core program; 3) text messages; 4) diet-appropriate food and cookbooks |
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| Breath meter | Behavioral | We will send participants a breath meter to test ketones in their breath, to assess dietary adherence. |
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| Text messages | Behavioral | We will send participants text messages, to support intervention adherence. |
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| Diet-appropriate foods and cookbooks | Behavioral | We will send participants diet-appropriate foods and cookbooks, to support intervention adherence. |
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| D004700 | Endocrine System Diseases |