Examining the Effects of Diet on Health in Prediabetes With an Online Program
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|ClinicalTrials.gov Identifier: NCT02188823|
Recruitment Status : Terminated (low recruitment)
First Posted : July 14, 2014
Last Update Posted : June 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prediabetes||Behavioral: Low carbohydrate diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Examining the Effects of Diet on Health in Prediabetes With an Online Program|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Low Carbohydrate Diet
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 exercise, sleep, 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
- Hemoglobin A1c [ Time Frame: baseline to 16 weeks ]We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks.
- Body weight [ Time Frame: baseline to 16 weeks ]We will test whether body weight changes from pre-intervention to 16 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188823
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|