Examining the Effects of Diet on Health in Prediabetes With an Online Program

Not Applicable

Terminated

• Conditions: Prediabetes
• Interventions: Behavioral: Low carbohydrate diet

• Registration Number: NCT02188823
• Lead Sponsor: University of California, San Francisco

Brief Summary

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 clinical trial assessing a programs to help people manage prediabetes and lose weight with a low-carbohydrate diet (LC) along with information about positive affect, mindful eating strategies, exercise, and sleep.

Detailed Description

Individuals with prediabetes will be assigned to the treatment group. Classes will occur online. Participants will be evaluated at 0, 8, and 16 weeks. Our main outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity) at 16 weeks.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-14
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Carbohydrate Diet	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.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	baseline to 16 weeks	We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks.

Secondary Outcome Measures

Name	Time	Method
Body weight	baseline to 16 weeks	We will test whether body weight changes from pre-intervention to 16 weeks.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States