A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
SUCCEED
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedDecember 30, 2013
December 1, 2013
1.1 years
August 24, 2012
December 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Change from baseline to 3 months
Secondary Outcomes (1)
Hemoglobin A1c
Change from baseline to 6 months
Study Arms (2)
Low Carbohydrate Diet
EXPERIMENTALParticipants 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.
American Diabetes Association Diet
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Osher Center for Integrative Medicine
San Francisco, California, 94143, United States
Related Publications (1)
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.
PMID: 24717684DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederick M Hecht, M.D.
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2012
First Posted
October 25, 2012
Study Start
October 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
December 30, 2013
Record last verified: 2013-12