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A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics (SUCCEED)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01713764
First received: August 24, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

The study is a small 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 mindfulness-based lifestyle modification programs to help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and the other using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA). Intervention content will include information about nutrition (carbohydrate restriction or American Diabetes Association recommended diet) and emotion regulation and mindful eating strategies.


Condition Intervention Phase
Diabetes Type II
 Behavioral: Low Carbohydrate 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: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]
    We test whether Hemoglobin A1c changes from pre-intervention to 3 months. The key outcome measure will compare the two diet groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 3 months.


Secondary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
    We test whether Hemoglobin A1c changes from pre-intervention to 6 months. The key outcome measure will compare the two diet groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 6 months.


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Carbohydrate Diet

Participants will be instructed to follow a low carbohydrate diet: carbohydrate intake 10-50 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: Low Carbohydrate Diet Behavioral: Mindfulness and Positive Affect Skills
Active Comparator: American Diabetes Association 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.

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: American Diabetes Association Diet Behavioral: Mindfulness and Positive Affect Skills

Detailed Description:

Approximately 40 individuals with Type II diabetes or prediabetes will be randomized in a 1:1 ratio to treatment groups. Groups will meet for 12 weekly sessions, then approximately biweekly for 3 sessions, for a total of 15 1.5-2 hour sessions over 4.5 months. Participants will be evaluated at 0, 1 month, 3 months, and 6 months. Our 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:

  • Diabetes mellitus, Type 2.
  • HgbA1c > 6.0% at screening. This is to confirm the diabetes diagnosis.
  • Aged 18 years old and older
  • BMI 25 and above.

Exclusion Criteria:

  • Condition that will make it difficult for participation. Such as:

    • cancer
    • liver failure
    • unstable coronary artery disease
    • severe emphysema
    • bulimia or strong history of bulimia
    • vegan

  • Laboratory evidence of organ dysfunction

    • Abnormal kidney function (serum creatinine)
    • thyroid stimulating hormone out of normal range

  • Previous use or new changes in medications that can interfere with the measures used in the study:

    • current use of insulin and no immediate plans to start or increase diabetic mediations.
    • more than 3 oral hypoglycemic medications.
    • use of systemic (oral or IV) corticosteroids in the 6 months prior
    • severe autoimmune disorders
    • initiation of psychiatric medications in past 2 months.

  • Weight loss confounds

    • Current use of weight loss medications or supplements.
    • History of or planned weight loss surgery.

  • Other

    • Pregnant or planning to get pregnant in the next year, breastfeeding, less than 6 months post-partum.
    • Unable or unwilling to do home glucose monitoring.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713764

Locations
United States, California
Osher Center for Integrative Medicine
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Frederick M Hecht, M.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01713764     History of Changes
Other Study ID Numbers: 12-09549
Study First Received: August 24, 2012
Last Updated: November 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
diabetes
obesity
mindful eating
 positive affect
low carbohydrate
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 May 22, 2013