A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics

Study Overview
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Brief Summary
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The study is a small 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 mindfulness-based lifestyle modification programs to help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and the other using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA). Intervention content will include information about nutrition (carbohydrate restriction or American Diabetes Association recommended diet) and emotion regulation and mindful eating strategies.

Detailed Description
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Approximately 40 individuals with Type II diabetes or prediabetes will be randomized in a 1:1 ratio to treatment groups. Groups will meet for 12 weekly sessions, then approximately biweekly for 3 sessions, for a total of 15 1.5-2 hour sessions over 4.5 months. Participants will be evaluated at 0, 1 month, 3 months, and 6 months. Our outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity).

Official Title
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A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics

Conditions
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Diabetes Type II

Intervention / Treatment
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* Behavioral: Low Carbohydrate Diet
* Behavioral: American Diabetes Association Diet
* Behavioral: Mindfulness and Positive Affect Skills


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes mellitus, Type 2. HgbA1c > 6.0% at screening. This is to confirm the diabetes diagnosis. Aged 18 years old and older BMI 25 and above. Exclusion Criteria: Condition that will make it difficult for participation. Such as: cancer liver failure unstable coronary artery disease severe emphysema bulimia or strong history of bulimia vegan Laboratory evidence of organ dysfunction Abnormal kidney function (serum creatinine) thyroid stimulating hormone out of normal range Previous use or new changes in medications that can interfere with the measures used in the study: current use of insulin and no immediate plans to start or increase diabetic mediations. more than 3 oral hypoglycemic medications. use of systemic (oral or IV) corticosteroids in the 6 months prior severe autoimmune disorders initiation of psychiatric medications in past 2 months. Weight loss confounds Current use of weight loss medications or supplements. History of or planned weight loss surgery. Other Pregnant or planning to get pregnant in the next year, breastfeeding, less than 6 months post-partum. Unable or unwilling to do home glucose monitoring.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Carbohydrate Diet<br>Participants will be instructed to follow a low carbohydrate diet: carbohydrate intake 10-50 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. | Behavioral: Low Carbohydrate Diet<br> <br> Behavioral: Mindfulness and Positive Affect Skills<br> <br> |
| Active Comparator: American Diabetes Association Diet<br>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. 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. | Behavioral: American Diabetes Association Diet<br> <br> Behavioral: Mindfulness and Positive Affect Skills<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | We test whether Hemoglobin A1c changes from pre-intervention to 3 months. The key outcome measure will compare the two diet groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 3 months. | Change from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | We test whether Hemoglobin A1c changes from pre-intervention to 6 months. The key outcome measure will compare the two diet groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 6 months. | Change from baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, obesity, mindful eating, positive affect, low carbohydrate, diet