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

Primary Purpose

Prediabetes

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low carbohydrate diet
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prediabetes focused on measuring prediabetes, obesity, mindful eating, positive affect, low carbohydrate, ketogenic, diet

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Inclusion criteria

    1. Self-reported clinical diagnosis of prediabetes occurring within the past year.
    2. Aged 18 years old and older
    3. Per the Centers for Disease Control and Prevention Diabetes Prevention Recognition Program have a self-reported body mass index (BMI) of ≥ 24 kg/m2 (≥ 22 kg/m2 if Asian).
    4. Willing and able to participate in the intervention such as having sufficient control over their food intake. Must have the ability to make choices about the food they eat; cannot have a lifestyle in which they eat out most of their meals.)
  • Exclusion criteria

    1. Unable to provide informed consent.
    2. Non English speaker. The intervention groups are conducted in English.
    3. No current use of insulin, no immediate plans to start or increase diabetic mediations, and no use of diabetes medications besides metformin. Insulin and other diabetes medications other than metformin can alter the safety of the diets, so to ensure greater safety, we will exclude diabetics using insulin or medications besides metformin.
    4. A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention. Such conditions may include: cancer, liver failure, unstable coronary artery disease, severe emphysema, binge eating disorder or history of binge eating disorder, bulimia or strong history of bulimia.
    5. Previous use or recent changes in medications that can interfere with the measures used in the study: current use of insulin; use of systemic (oral or IV) corticosteroids in the 1 month prior to enrollment or severe autoimmune disorders or other conditions (e.g. rheumatoid arthritis, lupus), that are likely to require these medications; and initiation of new class of psychiatric medications in past 2 months. Such medications can alter measures used in our research, such as assessments of markers of inflammation, or negatively influence the safety of the diets.
    6. Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum. The intervention is not designed for the particular diet considerations during pregnancy and breast-feeding.
    7. Current use of weight loss medications or supplements such as Alli or amphetamine-based drugs that are believed to have some effect on weight. Use of weight loss aids by potential participants will be reviewed by a core study team to determine whether participant would be eligible if they stop using the substance.
    8. History of or planned weight loss surgery. The intervention is not designed to address either the often substantial food intake limits that often result from weight loss surgery or the significantly disordered eating that people who fail this extreme intervention may have.
    9. Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants.
    10. No or very limited internet access at a computer. Must be able to complete the online assessments and access the online class materials.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low Carbohydrate Diet

Arm Description

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.

Outcomes

Primary Outcome Measures

Hemoglobin A1c
We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks.

Secondary Outcome Measures

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

Full Information

First Posted
July 10, 2014
Last Updated
June 14, 2017
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02188823
Brief Title
Examining the Effects of Diet on Health in Prediabetes With an Online Program
Official Title
Examining the Effects of Diet on Health in Prediabetes With an Online Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
low recruitment
Study Start Date
July 2014 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
Keywords
prediabetes, obesity, mindful eating, positive affect, low carbohydrate, ketogenic, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Carbohydrate Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low carbohydrate diet
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks.
Time Frame
baseline to 16 weeks
Secondary Outcome Measure Information:
Title
Body weight
Description
We will test whether body weight changes from pre-intervention to 16 weeks.
Time Frame
baseline to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Self-reported clinical diagnosis of prediabetes occurring within the past year. Aged 18 years old and older Per the Centers for Disease Control and Prevention Diabetes Prevention Recognition Program have a self-reported body mass index (BMI) of ≥ 24 kg/m2 (≥ 22 kg/m2 if Asian). Willing and able to participate in the intervention such as having sufficient control over their food intake. Must have the ability to make choices about the food they eat; cannot have a lifestyle in which they eat out most of their meals.) Exclusion criteria Unable to provide informed consent. Non English speaker. The intervention groups are conducted in English. No current use of insulin, no immediate plans to start or increase diabetic mediations, and no use of diabetes medications besides metformin. Insulin and other diabetes medications other than metformin can alter the safety of the diets, so to ensure greater safety, we will exclude diabetics using insulin or medications besides metformin. A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention. Such conditions may include: cancer, liver failure, unstable coronary artery disease, severe emphysema, binge eating disorder or history of binge eating disorder, bulimia or strong history of bulimia. Previous use or recent changes in medications that can interfere with the measures used in the study: current use of insulin; use of systemic (oral or IV) corticosteroids in the 1 month prior to enrollment or severe autoimmune disorders or other conditions (e.g. rheumatoid arthritis, lupus), that are likely to require these medications; and initiation of new class of psychiatric medications in past 2 months. Such medications can alter measures used in our research, such as assessments of markers of inflammation, or negatively influence the safety of the diets. Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum. The intervention is not designed for the particular diet considerations during pregnancy and breast-feeding. Current use of weight loss medications or supplements such as Alli or amphetamine-based drugs that are believed to have some effect on weight. Use of weight loss aids by potential participants will be reviewed by a core study team to determine whether participant would be eligible if they stop using the substance. History of or planned weight loss surgery. The intervention is not designed to address either the often substantial food intake limits that often result from weight loss surgery or the significantly disordered eating that people who fail this extreme intervention may have. Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants. No or very limited internet access at a computer. Must be able to complete the online assessments and access the online class materials.
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Links:
URL
http://ucbpsych.qualtrics.com/SE/?SID=SV_9LXQ9BJvMR1Qcbb
Description
eligibility survey

Learn more about this trial

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

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