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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
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE July 10, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date June 16, 2017
Actual Study Start Date  ICMJE July 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Hemoglobin A1c [ Time Frame: baseline to 16 weeks ]
We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Body weight [ Time Frame: baseline to 16 weeks ]
We will test whether body weight changes from pre-intervention to 16 weeks.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examining the Effects of Diet on Health in Prediabetes With an Online Program
Official Title  ICMJE Examining the Effects of Diet on Health in Prediabetes With an Online Program
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prediabetes
Intervention  ICMJE Behavioral: Low carbohydrate diet
Study Arms  ICMJE 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.

Intervention: Behavioral: Low carbohydrate diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 14, 2017)
11
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2014)
50
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188823
Other Study ID Numbers  ICMJE 13-11813p
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, San Francisco
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP