Trial Outcomes & Findings for Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger (NCT NCT03207711)
NCT ID: NCT03207711
Last Updated: 2025-12-08
Results Overview
Percent of ecological momentary assessment (EMA) opportunities in which participants reported eating in response to food cravings over a 3 day period. EMA measures were delivered to cell phones 3 times each day. The final EMA measure each day included a second question about whether there were any instances of craving related eating not already reported earlier during the day. Thus there was an opportunity to report eating in response to cravings on 4 different EMA questions each day, a total of 12 potential measures over 3 days. The percent here uses the number of EMA responses received as the denominator.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
change from baseline to 6 months
Results posted on
2025-12-08
Participant Flow
Recruitment conducted 12/2016-9/2018 via several sources including: flyers posted in and outreach to providers in UCSF clinics (e.g., Diabetes Clinic, General Internal Medicine Clinic); letters mailed to potentially eligible participants in the UCSF system who had previously consented to be contacted about research studies for which they may be eligible; flyers posted in the community as on social media including Facebook, Nextdoor, and Craigslist. First participant was consented 2/17/2017.
Participant milestones
| Measure |
Diet Education
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Diet Education
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger
Baseline characteristics by cohort
| Measure |
Diet Education
n=28 Participants
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=30 Participants
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 10.9 • n=37 Participants
|
59.0 years
STANDARD_DEVIATION 11.2 • n=37 Participants
|
58.7 years
STANDARD_DEVIATION 10.9 • n=74 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=37 Participants
|
17 Participants
n=37 Participants
|
37 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=37 Participants
|
13 Participants
n=37 Participants
|
21 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
7 Participants
n=37 Participants
|
5 Participants
n=37 Participants
|
12 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
3 Participants
n=37 Participants
|
3 Participants
n=37 Participants
|
6 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Latino/Hispanic
|
4 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
6 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic White
|
14 Participants
n=37 Participants
|
15 Participants
n=37 Participants
|
29 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Other/more than 1 race
|
0 Participants
n=37 Participants
|
5 Participants
n=37 Participants
|
5 Participants
n=74 Participants
|
|
Education
High school or less
|
1 participants
n=37 Participants
|
1 participants
n=37 Participants
|
2 participants
n=74 Participants
|
|
Education
Some college
|
5 participants
n=37 Participants
|
12 participants
n=37 Participants
|
17 participants
n=74 Participants
|
|
Education
4-year college degree
|
13 participants
n=37 Participants
|
7 participants
n=37 Participants
|
20 participants
n=74 Participants
|
|
Education
Advanced degree
|
9 participants
n=37 Participants
|
9 participants
n=37 Participants
|
18 participants
n=74 Participants
|
|
Education
Declined to report
|
0 participants
n=37 Participants
|
1 participants
n=37 Participants
|
1 participants
n=74 Participants
|
PRIMARY outcome
Timeframe: change from baseline to 6 monthsPercent of ecological momentary assessment (EMA) opportunities in which participants reported eating in response to food cravings over a 3 day period. EMA measures were delivered to cell phones 3 times each day. The final EMA measure each day included a second question about whether there were any instances of craving related eating not already reported earlier during the day. Thus there was an opportunity to report eating in response to cravings on 4 different EMA questions each day, a total of 12 potential measures over 3 days. The percent here uses the number of EMA responses received as the denominator.
Outcome measures
| Measure |
Diet Education
n=28 Participants
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=30 Participants
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Frequency of Eating in Response to Cravings (Primary Mechanistic Outcome)
|
-20.39 % of EMAs with craving related eating
Interval -28.15 to -12.62
|
-25.27 % of EMAs with craving related eating
Interval -32.95 to -17.58
|
SECONDARY outcome
Timeframe: change from baseline to 6 monthsPopulation: Intent to treat; note 2 participants in each arm had impulsivity data excluded due to nonsystematic Delayed Discounting data at baseline
The 5-trial adaptation of the Delayed Discounting (DD; Koffarnus \& Bickel, 2014) is a decision-making exercise where individuals choose between a smaller, immediate reward and a larger, delayed reward. The task measures an individual's "discount rate," or how much they devalue a future reward compared to an immediate one, which is a a key aspect of impulsivity and self-control. Respondents choose between $100 delivered after a delay, or $50 available immediately. To derive estimates of discount rate, we used Mazur's hyperbolic discounting model (V=A/ (1+kD)18, wherein V is the discounted value of the delayed option, A is its objective amount, D is its delay, and k indexes the discount rate. We calculated values of k for each participant as the inverse of the indifference delay (1/ED50). We log transformed these values prior to analysis. Higher values of K indicate greater discounting, which reflects greater impulsivity.
Outcome measures
| Measure |
Diet Education
n=26 Participants
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=28 Participants
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Change in Impulsivity as Measured by Delayed Discounting Score
|
87.17 % change
Interval -38.76 to 472.03
|
6.42 % change
Interval -63.45 to 209.89
|
SECONDARY outcome
Timeframe: change from baseline to 6 monthsChange in emotion-related eating as measured by the Coping subscale of the Palatable Eating Motives Scale (PEMS). The Coping subscale is comprised of 4 items rated on a scale from 1 (almost never/never) to 5 (almost always/always), with possible scores ranging from 4-20. Higher scores reflect worse coping/greater emotional eating. Thus, decreases over time reflect improved coping/decreased emotional eating.
Outcome measures
| Measure |
Diet Education
n=28 Participants
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=30 Participants
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Emotion-related Eating (Secondary Mechanistic Outcome)
|
-0.62 scores on a scale
Interval -1.0 to -0.25
|
-0.90 scores on a scale
Interval -1.27 to -0.53
|
SECONDARY outcome
Timeframe: change from baseline to 6 monthsChange in stress-related eating as measured by two questions about stress-related eating from the MIDUS study. Possible scores range from 2-8. Higher scores reflect worse outcomes/greater eating in response to stress. Thus, decreases over time reflect improved outcomes/decreased stress-related eating.
Outcome measures
| Measure |
Diet Education
n=28 Participants
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=30 Participants
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Stress-related Eating (Secondary Mechanistic Outcome)
|
-1.62 units on a scale
Interval -2.22 to -1.03
|
-1.73 units on a scale
Interval -2.32 to -1.15
|
SECONDARY outcome
Timeframe: change from baseline to 6 monthsChange in hemoglobin A1c (HbA1c) from baseline to 6 months by study arm
Outcome measures
| Measure |
Diet Education
n=28 Participants
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=30 Participants
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Glycemic Control, Using HbA1c
|
-1.32 % of hemaglobin with glucose (HbA1C)
Interval -1.65 to -0.98
|
-0.87 % of hemaglobin with glucose (HbA1C)
Interval -1.2 to -0.54
|
SECONDARY outcome
Timeframe: change from baseline to 6 monthsChange in plasma fasting glucose from baseline to 6 months by study arm
Outcome measures
| Measure |
Diet Education
n=28 Participants
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=30 Participants
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Fasting Glucose
|
-30.21 mg/dL
Interval -44.48 to -15.94
|
-25.92 mg/dL
Interval -39.67 to -12.17
|
SECONDARY outcome
Timeframe: change from baseline to 6 monthsInsulin resistance estimated from the Homeostatic model assessment (HOMA) model 2 index of insulin resistance. The basic formula is: (glucose × insulin) / 22.5, where glucose is measured in mmol/L and insulin in mU/L. The computer assisted re-calibration in model 2 addresses variations in the glucose resistance of the peripheral tissue and liver, increases in the insulin secretion curve for glucose \> 180 mg/dL, and contribution of circulating pro-insulin. Higher values indicate more insulin resistance (worse outcome). The Oxford University HOMA-2IR calculator was used (https://process.innovation.ox.ac.uk/software/p/2112/homa2-calculator/1). HOMA index values \< 2.0 are generally considered normal and indicate adequate sensitivity of cells to insulin. HOMA index values between 2.0 and 2.5 may indicate borderline changes in insulin sensitivity. HOMA index values \> 2.5 clearly indicate insulin resistance.
Outcome measures
| Measure |
Diet Education
n=28 Participants
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=30 Participants
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
HOMA-2IR Index of Insulin Resistance (Secondary Clinical Outcome)
|
-0.45 units on a scale
Interval -0.93 to 0.02
|
-0.85 units on a scale
Interval -1.3 to -0.4
|
SECONDARY outcome
Timeframe: change from baseline to 6 monthskilograms
Outcome measures
| Measure |
Diet Education
n=28 Participants
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=30 Participants
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Weight Change(Secondary Clinical Outcome)
|
-4.96 kilograms
Interval -6.44 to -3.49
|
-4.43 kilograms
Interval -5.88 to -2.98
|
SECONDARY outcome
Timeframe: 6 monthsAdherence to diet as measured by average proportion of fingerstick blood ketones at or above 0.3 mmol/L at 24 weeks.
Outcome measures
| Measure |
Diet Education
n=28 Participants
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=30 Participants
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Adherence to Diet as Measured by Fingerstick Blood Ketones
|
0.46 proportion of measurements >= 0.3 mmol/L
Interval 0.26 to 0.66
|
0.60 proportion of measurements >= 0.3 mmol/L
Interval 0.41 to 0.79
|
SECONDARY outcome
Timeframe: change from baseline to 6 monthsDiet Adherence Between Intervention Arms as Measured by Mean Grams of Non-fiber Carbohydrate Consumed Per Day From 24- Hour Diet Recall
Outcome measures
| Measure |
Diet Education
n=28 Participants
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=30 Participants
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Diet Adherence by Mean Grams of Non-fiber Carbohydrate Consumed Per Day
|
-91.43 grams
Interval -123.73 to -59.14
|
-116.92 grams
Interval -148.53 to -85.31
|
SECONDARY outcome
Timeframe: change from baseline to 6 monthsPerceived Stress Scale (PPS-10) total score. Scores can range from 0 to 40 with higher scores indicated greater perceived stress.
Outcome measures
| Measure |
Diet Education
n=28 Participants
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=30 Participants
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Perceived Stress
|
-1.09 score on a scale
Interval -2.73 to 0.55
|
-2.04 score on a scale
Interval -3.65 to -0.44
|
Adverse Events
Diet Education
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Diet Education + Mindfulness
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diet Education
n=28 participants at risk
All participants will receive instruction in the carbohydrate-restricted diet (CR).The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
|
Diet Education + Mindfulness
n=30 participants at risk
In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.
Carbohydrate-restricted diet: Education for carbohydrate-restricted diet
Mindfulness: Mindful eating app-use and instruction
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
21.4%
6/28 • Number of events 7 • 6 months
|
3.3%
1/30 • Number of events 2 • 6 months
|
|
Cardiac disorders
Hypertriglyceridemia
|
14.3%
4/28 • Number of events 4 • 6 months
|
0.00%
0/30 • 6 months
|
|
General disorders
other
|
21.4%
6/28 • Number of events 9 • 6 months
|
36.7%
11/30 • Number of events 14 • 6 months
|
Additional Information
Frederick Hecht, MD
University of California, San Francisco
Phone: (415) 353-9743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place