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

Primary Purpose

Diabetes Type II

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low Carbohydrate Diet
American Diabetes Association Diet
Mindfulness and Positive Affect Skills
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type II focused on measuring diabetes, obesity, mindful eating, positive affect, low carbohydrate, diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Osher Center for Integrative Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Carbohydrate Diet

American Diabetes Association Diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hemoglobin A1c
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
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.

Full Information

First Posted
August 24, 2012
Last Updated
December 24, 2013
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01713764
Brief Title
A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
Acronym
SUCCEED
Official Title
A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (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 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type II
Keywords
diabetes, obesity, mindful eating, positive affect, low carbohydrate, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (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 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.
Arm Title
American Diabetes Association Diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low Carbohydrate Diet
Intervention Type
Behavioral
Intervention Name(s)
American Diabetes Association Diet
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness and Positive Affect Skills
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
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.
Time Frame
Change from baseline to 3 months
Secondary Outcome Measure Information:
Title
Hemoglobin A1c
Description
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.
Time Frame
Change from baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick M Hecht, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osher Center for Integrative Medicine
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24717684
Citation
Saslow LR, Kim S, Daubenmier JJ, Moskowitz JT, Phinney SD, Goldman V, Murphy EJ, Cox RM, Moran P, Hecht FM. A randomized pilot trial of a moderate carbohydrate diet compared to a very low carbohydrate diet in overweight or obese individuals with type 2 diabetes mellitus or prediabetes. PLoS One. 2014 Apr 9;9(4):e91027. doi: 10.1371/journal.pone.0091027. eCollection 2014.
Results Reference
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A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics

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