Diabetes Type IIPhase 2SUCCEEDNCT01713764
A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
A Phase 2 study testing Low Carbohydrate Diet, American Diabetes Association Diet and Mindfulness and Positive Affect Skills in people with Diabetes Type II, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type II
- What is being tested?
- Low Carbohydrate Diet, American Diabetes Association Diet and Mindfulness and Positive Affect Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Osher Center for Integrative Medicine
San Francisco, California, 94143
About this study
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.
Read the 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).
- Conditions
- Diabetes Type II
- Being tested
- Low Carbohydrate Diet, American Diabetes Association Diet, Mindfulness and Positive Affect Skills
- Keywords
- diabetes, obesity, mindful eating, positive affect, low carbohydrate, diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Carbohydrate DietBehavioural
American Diabetes Association DietBehavioural
Mindfulness and Positive Affect SkillsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Low Carbohydrate Diet | Experimental | 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. Receives: Behavioral: Low Carbohydrate Diet; Behavioral: Mindfulness and Positive Affect Skills |
| American Diabetes Association Diet | Active comparator | 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. Receives: Behavioral: American Diabetes Association Diet; Behavioral: Mindfulness and Positive Affect Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 3 months
Secondary outcomes (1)
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.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type IIStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick M Hecht, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713764
- Sponsor's protocol ID
- 12-09549
- Acronym
- SUCCEED
- Status last verified
- Dec 2013
- First submitted
- 24 Aug 2012
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24717684
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
- ClinicalTrials.gov ID
- NCT01713764
- Acronym / sponsor ID
- SUCCEED / 12-09549
- Conditions
- Diabetes Type II
- Keywords
- diabetes, obesity, mindful eating, positive affect, low carbohydrate, diet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Carbohydrate Diet | Experimental | Behavioral: Low Carbohydrate Diet, Behavioral: Mindfulness and Positive Affect SkillsParticipants 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 comparator | Behavioral: American Diabetes Association Diet, Behavioral: Mindfulness and Positive Affect SkillsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (22 listed)
- Condition that will make it difficult for participation. Such as:
- Laboratory evidence of organ dysfunction
- Previous use or new changes in medications that can interfere with the measures used in the study:
- Weight loss confounds
- Other
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Carbohydrate Diet | Behavioural | Low Carbohydrate Diet |
| American Diabetes Association Diet | Behavioural | American Diabetes Association Diet |
| Mindfulness and Positive Affect Skills | Behavioural | American Diabetes Association Diet, Low Carbohydrate Diet |
Primary outcome
Hemoglobin A1c
Time frame: Change from baseline to 3 months
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.
1 secondary outcome
Hemoglobin A1c
Time frame: Change from baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
- Derived from this study: PubMed 24717684Saslow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick M Hecht, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low Carbohydrate Diet, American Diabetes Association Diet and Mindfulness and Positive Affect Skills in people with Diabetes Type II, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: Change from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01713764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2013.