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The study is a pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a randomized controlled clinical trial comparing two programs to help people manage diabetes and lose weight, one using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA) and the other using on a low-carbohydrate diet (LC) and mindfulness and positive affect lifestyle modifications. Intervention content will include information about nutrition (American Diabetes Association recommended diet or carbohydrate restriction) and, in the LC group, emotion regulation, positive affect, and mindful eating strategies.
Approximately individuals with type 2 diabetes will be randomized in a 1:1 ratio to treatment groups. Classes will occur online. Participants will be evaluated at 0, 16, and 32 weeks. Our main outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| American Diabetes Association recommended diet | Active Comparator | Participants in the American Diabetes Association (ADA) diet group will receive standard ADA advice. The diet includes high-fiber foods (such as vegetables, fruits, whole grains, and legumes), low-fat dairy products, fresh fish, and foods low in saturated fat. They will be asked to use the "plate method" to guide their nutritional choices. |
|
| Low Carbohydrate Diet | Experimental | Participants will be instructed to follow a low carbohydrate, ketogenic diet: carbohydrate intake 20-35 grams a day not including fiber. Foods permitted include: meats, poultry, fish, eggs, cheese, cream, some nuts and seeds, green leafy vegetables, and most other non-starchy vegetables. Because most individuals self-limit caloric intake, no calorie restriction will be recommended. Participants will also be taught information about mindfulness and positive affect practices. The mindfulness-based curriculum will focus on the following elements: training on topics such as mindful meditation, mindful eating, awareness of fullness and hunger signals, and taste satiety. The positive emotion curriculum will include: training on topics such as noticing and savoring positive events, gratitude, positive reappraisal, personal strengths, attainable goals, and acts of kindness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral: Low Carbohydrate, Ketogenic Diet | Behavioral |
| ||
| American Diabetes Association Diet |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 16 weeks. | baseline to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | We will test whether Hemoglobin A1c changes from pre-intervention to 32 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 32 weeks. | baseline to 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | We will test whether body weight changes from pre-intervention to 16 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 16 weeks. | baseline to 16 weeks |
| Body weight |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura R Saslow, PhD | University of Michigan | Principal Investigator |
| Rick Hecht, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28193599 | Derived | Saslow LR, Mason AE, Kim S, Goldman V, Ploutz-Snyder R, Bayandorian H, Daubenmier J, Hecht FM, Moskowitz JT. An Online Intervention Comparing a Very Low-Carbohydrate Ketogenic Diet and Lifestyle Recommendations Versus a Plate Method Diet in Overweight Individuals With Type 2 Diabetes: A Randomized Controlled Trial. J Med Internet Res. 2017 Feb 13;19(2):e36. doi: 10.2196/jmir.5806. |
| Label | URL |
|---|---|
| recruitment website for study | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Behavioral |
|
| Mindfulness and Positive Affect Skills | Behavioral |
|
We will test whether body weight changes from pre-intervention to 32 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 32 weeks. |
| baseline to 32 weeks |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |