Examining the Effects of Diet on Health With an Online Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01967992
First received: October 18, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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 randomized controlled clinical trial comparing two programs to help people manage diabetes and lose weight, one using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA) and the other using on a low-carbohydrate diet (LC) and mindfulness and positive affect lifestyle modifications. Intervention content will include information about nutrition (American Diabetes Association recommended diet or carbohydrate restriction) and, in the LC group, emotion regulation, positive affect, and mindful eating strategies.


Condition Intervention Phase
Type 2 Diabetes
Behavioral: Behavioral: Low Carbohydrate, Ketogenic Diet
Behavioral: American Diabetes Association Diet
Behavioral: Mindfulness and Positive Affect Skills
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examining the Effects of Diet on Health With an Online Program

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]
    We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 16 weeks.


Secondary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: baseline to 32 weeks ] [ Designated as safety issue: No ]
    We will test whether Hemoglobin A1c changes from pre-intervention to 32 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 32 weeks.


Other Outcome Measures:
  • Body weight [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]
    We will test whether body weight changes from pre-intervention to 16 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 16 weeks.

  • Body weight [ Time Frame: baseline to 32 weeks ] [ Designated as safety issue: No ]
    We will test whether body weight changes from pre-intervention to 32 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 32 weeks.


Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: American Diabetes Association recommended diet
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. They will be asked to use the "plate method" to guide their nutritional choices.
Behavioral: American Diabetes Association Diet
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 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: Behavioral: Low Carbohydrate, Ketogenic Diet Behavioral: Mindfulness and Positive Affect Skills

Detailed Description:

Approximately individuals with type 2 diabetes will be randomized in a 1:1 ratio to treatment groups. Classes will occur online. Participants will be evaluated at 0, 16, and 32 weeks. Our main outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HbA1c 6.5%-9% at screening.
  2. Aged 18 years old and older
  3. BMI 25 and above.
  4. Willing and able to participate in the interventions 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.
  3. No current use of insulin, no immediate plans to start or increase diabetic mediations, and no use of diabetes 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 6 months 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.
  6. Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum.
  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.
  8. History of or planned weight loss surgery.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967992

Contacts
Contact: Vierka Goldman 415-514-8476 SUCCEED@ocim.ucsf.edu
Contact: Laura Saslow 415-514-8476 SaslowL@ocim.ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Laura R Saslow, PhD University of California, San Francisco
Principal Investigator: Rick Hecht, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01967992     History of Changes
Other Study ID Numbers: 13-11813
Study First Received: October 18, 2013
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
diabetes
obesity
mindful eating
positive affect
low carbohydrate
ketogenic
diet

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014