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| ID | Type | Description | Link |
|---|---|---|---|
| 4R33AT009333 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The investigators plan an R33 phase trial in which 120 persons with type 2 diabetes (T2DM) will be randomized (using a 1:1 ratio) to education alone (Ed) on following a carbohydrate restricted diet for T2DM, or this same education content with added mindful eating/Mindfulness-Based Intervention components (Ed+MBI).
The investigators will randomize 120 persons with T2DM in a 1:1 ratio to a nutrition education alone arm (Ed n=60) vs. a nutrition education with mindfulness-based intervention components (Ed+MBI n=60) arm and follow them for 12 months. The interventions will be provided in a weekly group setting, with about 10 to 12 persons per group. Some educational intervention components will be delivered using a smartphone app. After the 12-week initial intervention, the investigators will re-randomize participants using an adaptive intervention design to receive low, medium, or high intensity maintenance training, depending on level of adherence achieved during the initial intervention period. Follow-up assessments will be performed at 3, 6, 9, and 12 months. The investigators will address the following specific aims:
This is the second phase of a two-phase study. Pilot testing has been completed in the first phase (R61). The focus of the second phase (R33) is on comparing dietary adherence between the Ed only and ED + MBI arms over a 12-month period. This phase will also include employing an adaptive intervention design in the post-treatment phase to test optimization of the maintenance intervention (i.e. assigning maintenance intensity/dose based on how a participant is doing). The maintenance phase intensities will be assessed to provide preliminary data for planning future trials. The primary analysis focus of this phase will be on the comparing the groups formed by the initial randomization to Ed versus Ed + MBI. The investigators will use fingerstick blood ketone measures, which provide an objective measure of whether the target levels of carbohydrate restriction have been attained, as our primary adherence outcome measure. This will be supplemented by 24-hour diet recall measures of carbohydrate consumption. Important secondary outcome measures will include clinical measures such as glycosylated hemoglobin and behavioral measures such as frequency of eating in response to food cravings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet Education | Active Comparator | All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. 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. |
|
| Diet Education + Mindfulness | Experimental | In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbohydrate-restricted diet | Behavioral | Education for carbohydrate-restricted diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diet Adherence Between Intervention Arms as Measured by % of Ketones >= 0.5 mmol/L | Percent of participant ketone measures > or = 0.5 mmol/L during trial, by study arm | Measures from ketone measure initiation (week 5) to 12 months. Ketones were measured daily over 7 days at 5 study timepoints: 5 weeks, 3, 6, 9, and 12 months. |
| Diet Adherence Between Intervention Arms as Measured by % of Participants in Each Arm With < 50 Grams/Day of Non-fiber Carbohydrate on 24- Hour Diet Recall | Average percent of participant measures with consumption of < 50 grams/day of non-fiber carbohydrate (from 24-hour diet recall) by arm. Each participant was assigned a % of up to three measures reporting < 50 grams/day of non-fiber carbohydrate consumption, and this percent was averaged across each arm. | Average of three measures, done at 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Emotion-related Eating | change in emotion-related eating as measured by the Coping subscale of the Palatable Eating Motives Scale (PEMS). The coping subscale ranges from 1 to 5 (based on a mean of 4 items), with higher values indicating more emotion-related eating (the intervention aimed to lower this score--lower scores represent improvement). | change from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stress-related Eating | Change in stress-related eating as measured by two questions about stress-related eating from the MIDUS study and one additional stress-related eating question. Range is 2 to 8. Higher scores indicate more stress-related eating. | change from baseline to 12 months |
| Perceived Stress Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rick Hecht, MD | University of California, San Francisco | Principal Investigator |
| Elissa Epel, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osher Center for Integrative Medicine | San Francisco | California | 94115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diet Education Initial Randomization | All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. 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. Carbohydrate-restricted diet: Education for carbohydrate-restricted diet |
| FG001 | Diet Education + Mindfulness Initial Randomization | In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. Carbohydrate-restricted diet: Education for carbohydrate-restricted diet Mindfuless: Mindful eating app use plus group sessions to learn mindfulness |
| FG002 | Ed+MBI High Adherence/Low Intensity Maintenance | Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. Ed+MBI arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed+MBI participants with high adherence randomized to low intensity maintenance. |
| FG003 | Ed+MBI High Adherence/Medium Intensity Maintenance | Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. Ed+MBI arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed+MBI participants with high adherence randomized to medium intensity maintenance. |
| FG004 | Ed+MBI Low Adherence/Medium Intensity Maintenance | Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. Ed+MBI arm participants with low adherence during 3 month main intervention period were randomized to either medium or high intensity maintenance. This arm consists of Ed+MBI participants with high adherence randomized to medium intensity maintenance. |
| FG005 | Ed+MBI Low Adherence/High Intensity Maintenance | Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. Ed+MBI arm participants with low adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed+MBI participants with low adherence randomized to high intensity maintenance. Ed+MBI arm participants with low adherence during main intervention period randomized to high intensity maintenance. |
| FG006 | Ed Arm High Adherence/Low Intensity Maintenance | Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Ed arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed participants with high adherence randomized to low intensity maintenance. |
| FG007 | Ed High Adherence/Medium Intensity Maintenance | Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Ed arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed participants with high adherence randomized to medium intensity maintenance. |
| FG008 | Ed Low Adherence/Medium Intensity Maintenance | Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Ed arm participants with low adherence during 3 month main intervention period were randomized to either medium or high intensity maintenance. This arm consists of Ed participants with low adherence randomized to medium intensity maintenance. |
| FG009 | Ed Low Adherence/High Intensity Maintenance | Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Ed arm participants with low adherence during 3 month main intervention period were randomized to either medium or high intensity maintenance. This arm consists of Ed participants with low adherence randomized to high intensity maintenance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: 3-month Main Intervention |
| |||||||||||||
| Period 2: 9-month Maintenance |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diet Education | All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. 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. Carbohydrate-restricted diet: Education for carbohydrate-restricted diet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diet Adherence Between Intervention Arms as Measured by % of Ketones >= 0.5 mmol/L | Percent of participant ketone measures > or = 0.5 mmol/L during trial, by study arm | All trial participants with ketone measures. Ketone measures started at week 5 of the trial and ended at month 12. | Posted | Mean | Standard Deviation | % of ketone measures >= 0.5 mmol/L | Measures from ketone measure initiation (week 5) to 12 months. Ketones were measured daily over 7 days at 5 study timepoints: 5 weeks, 3, 6, 9, and 12 months. |
|
1 year
Adverse events were collected systematically on weekly surveys during the weekly class intervention phase (approximately 3 months), then on monthly survey for the remainder of the study, as well as at 3, 6, 9, and 12 month study visits that included labs. We monitored hypoglycemia and serum fasting lipid profiles, using the CTCAE criteria for grading severity.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1: Diet Education | All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
We changed study procedures in March 2020 due to the COVID-19 pandemic. The key change was holding study group intervention meetings and study visits over a video-conference platform (Zoom) rather than in person. The final cohort (of 5) was enrolled and all interventions delivered using online methods. Questionnaires throughout the trial used an online platform (Qualtrics) and did not change, but some secondary outcome behavioral measures had to be dropped as they could not be done remotely.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frederick Hecht, MD | University of California, San Francisco | (415) 353-9743 | rick.hecht@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2020 | May 21, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2020 | Jun 22, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Blood tests at LabCorp and 24-hour dietary recall interviews are done by research assistants blinded to treatment assignment.
| Mindfuless | Behavioral | Mindful eating app use plus group sessions to learn mindfulness |
|
| Glycemic Control--HbA1c | Change in Hemoglobin A1c from baseline to 12 months with study arm | change from baseline to 12 months |
| Frequency of Eating in Response to Cravings | Frequency of eating in response to cravings (indulgence) using ecological momentary assessment (EMA), operationalized as the percent of solicited occasions when a participant reported eating in response to cravings (rather than in response merely to hunger). Participants received 18 queries about eating in response to cravings over 3 days. Participants had to respond to at least 9 queries to have adequate data completeness for analysis. Frequency of eating in response to cravings is the proportion (scaled as a percent) of queries that participants responded to with responses that reported eating in response to cravings. | Change from baseline to 12 months |
| Diet Adherence Between Intervention Arms as Measured by Mean Grams of Non-fiber Carbohydrate Consumed Per Day From 24- Hour Diet Recall | Mean grams of non-fiber carbohydrate consumed per day (from 24-hour diet recall) during trial. We calculated average grams of non-fiber consumed per day across up to three measures during the trial for each participant, and this was averaged across arms. | From 3 to 12 months, using measures done at 3, 6, and 12 months |
| Salzburg Stress Eating Scale | Change in stress-related eating as measured by Salzburg Stress Eating Scale. Range is from 1 to 5. Higher scores indicate greater stress-related eating. | change from baseline to 12 months |
| Weight Change | Body mass in kilograms (kg) from baseline to 12 months | change from baseline to 12 month weight data |
Change in Perceived Stress Scale total score. Range is 0 to 40. Higher scores indicate more perceived stress. |
| change from baseline to 12 months |
| HOMA-2IR Index of Insulin Resistance | Insulin 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. | change from baseline to 12 months |
| Fasting Glucose | Glycemic control as measured by fasting blood glucose | change from baseline to 12 months |
| Mindfulness: FFMQ | Five-factor mindfulness questionnaire scale (FFMQ). Values represent an overall score summing five sub-scales. Range is 24 to 120. Higher scores indicate greater mindfulness. | change from baseline to 12 months |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Diet Education + Mindfulness | In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. Carbohydrate-restricted diet: Education for carbohydrate-restricted diet Mindfuless: Mindful eating app use plus group sessions to learn mindfulness |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemoglobin A1c | Measure of average blood glucose over approximately 3 months. It is used for diagnosing and monitoring diabetes, as well as assessing overall blood sugar control. | Mean | Standard Deviation | % of hemaglobin with glycosolation |
|
| OG001 | Diet Education + Mindfulness | In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. |
|
|
| Primary | Diet Adherence Between Intervention Arms as Measured by % of Participants in Each Arm With < 50 Grams/Day of Non-fiber Carbohydrate on 24- Hour Diet Recall | Average percent of participant measures with consumption of < 50 grams/day of non-fiber carbohydrate (from 24-hour diet recall) by arm. Each participant was assigned a % of up to three measures reporting < 50 grams/day of non-fiber carbohydrate consumption, and this percent was averaged across each arm. | All study participants with 24-hour dietary recall data. | Posted | Mean | 95% Confidence Interval | percentage of participants | Average of three measures, done at 3, 6 and 12 months |
|
|
|
| Secondary | Emotion-related Eating | change in emotion-related eating as measured by the Coping subscale of the Palatable Eating Motives Scale (PEMS). The coping subscale ranges from 1 to 5 (based on a mean of 4 items), with higher values indicating more emotion-related eating (the intervention aimed to lower this score--lower scores represent improvement). | Participants with PEMS coping measured at 12 months | Posted | Mean | 95% Confidence Interval | points on a scale | change from baseline to 12 months |
|
|
|
| Secondary | Glycemic Control--HbA1c | Change in Hemoglobin A1c from baseline to 12 months with study arm | All study participants with 12 month data | Posted | Mean | 95% Confidence Interval | % of hemaglobin with glucose | change from baseline to 12 months |
|
|
|
| Secondary | Frequency of Eating in Response to Cravings | Frequency of eating in response to cravings (indulgence) using ecological momentary assessment (EMA), operationalized as the percent of solicited occasions when a participant reported eating in response to cravings (rather than in response merely to hunger). Participants received 18 queries about eating in response to cravings over 3 days. Participants had to respond to at least 9 queries to have adequate data completeness for analysis. Frequency of eating in response to cravings is the proportion (scaled as a percent) of queries that participants responded to with responses that reported eating in response to cravings. | Participants who completed the required number of EMA assessments at baseline and 12 months | Posted | Mean | 95% Confidence Interval | Mean % EMA responses w/craving eating | Change from baseline to 12 months |
|
|
|
| Secondary | Diet Adherence Between Intervention Arms as Measured by Mean Grams of Non-fiber Carbohydrate Consumed Per Day From 24- Hour Diet Recall | Mean grams of non-fiber carbohydrate consumed per day (from 24-hour diet recall) during trial. We calculated average grams of non-fiber consumed per day across up to three measures during the trial for each participant, and this was averaged across arms. | All study participants with 24-hour dietary recall data. | Posted | Mean | Standard Deviation | grams non-fiber carbohydrate per day | From 3 to 12 months, using measures done at 3, 6, and 12 months |
|
|
|
| Secondary | Salzburg Stress Eating Scale | Change in stress-related eating as measured by Salzburg Stress Eating Scale. Range is from 1 to 5. Higher scores indicate greater stress-related eating. | All trial participants with 12 month data | Posted | Mean | 95% Confidence Interval | units on a scale | change from baseline to 12 months |
|
|
|
| Secondary | Weight Change | Body mass in kilograms (kg) from baseline to 12 months | All trial participants with 12 month data | Posted | Mean | 95% Confidence Interval | kg | change from baseline to 12 month weight data |
|
|
|
| Other Pre-specified | Stress-related Eating | Change in stress-related eating as measured by two questions about stress-related eating from the MIDUS study and one additional stress-related eating question. Range is 2 to 8. Higher scores indicate more stress-related eating. | All participants with 12 month data | Posted | Mean | 95% Confidence Interval | score on a scale | change from baseline to 12 months |
|
|
|
| Other Pre-specified | Perceived Stress Scale | Change in Perceived Stress Scale total score. Range is 0 to 40. Higher scores indicate more perceived stress. | All participants with 12 month data | Posted | Mean | 95% Confidence Interval | score on a scale | change from baseline to 12 months |
|
|
|
| Other Pre-specified | HOMA-2IR Index of Insulin Resistance | Insulin 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. | All participants with 12 month lab data except n=6 with baseline insulin values out of recommended range for HOMA-2IR calculation (insulin should be 20 to 400 picamoles/L). | Posted | Mean | 95% Confidence Interval | index | change from baseline to 12 months |
|
|
|
| Other Pre-specified | Fasting Glucose | Glycemic control as measured by fasting blood glucose | All participants with fasting glucose levels at baseline and 12 months. There n=6 participants included without a confirmed report of fasting from the lab. | Posted | Mean | 95% Confidence Interval | mg/dL | change from baseline to 12 months |
|
|
|
| Other Pre-specified | Mindfulness: FFMQ | Five-factor mindfulness questionnaire scale (FFMQ). Values represent an overall score summing five sub-scales. Range is 24 to 120. Higher scores indicate greater mindfulness. | All participants with 12-month data. | Posted | Mean | 95% Confidence Interval | score on a scale | change from baseline to 12 months |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 24 |
| 63 |
| EG001 | Period 1: Diet Education + Mindfulness | In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. | 0 | 62 | 0 | 62 | 25 | 62 |
| EG002 | Period 2: Ed+MBI High Adherence/Low Intensity Maintenance | Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. Ed+MBI arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed+MBI participants with high adherence randomized to low intensity maintenance. | 0 | 15 | 0 | 15 | 8 | 15 |
| EG003 | Period 2: Ed+MBI High Adherence/Medium Intensity Maintenance | Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. Ed+MBI arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed+MBI participants with high adherence randomized to medium intensity maintenance. | 1 | 15 | 0 | 15 | 8 | 15 |
| EG004 | Period 2: Ed+MBI Low Adherence/Medium Intensity Maintenance | Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. Ed+MBI arm participants with low adherence during 3 month main intervention period were randomized to either medium or high intensity maintenance. This arm consists of Ed+MBI participants with high adherence randomized to medium intensity maintenance. | 0 | 15 | 0 | 15 | 13 | 15 |
| EG005 | Period 2: Ed+MBI Low Adherence/High Intensity Maintenance | Participants randomized to the period 1 Ed+MBI arm received instruction in the Carbohydrate-Restricted (CR) diet that was identical to the Ed alone arm, but also received a mindfulness-based program (MBI) in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Participants in this arm also received mindfulness components using the Eat Right Now (ERN) platform. This consisted of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. Ed+MBI arm participants with low adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed+MBI participants with low adherence randomized to high intensity maintenance. | 0 | 15 | 0 | 15 | 6 | 15 |
| EG006 | Period 2: Ed High Adherence: Low Intensity | Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Ed arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed participants with high adherence randomized to low intensity maintenance. | 0 | 15 | 0 | 15 | 8 | 15 |
| EG007 | Period 2: Ed High Adherence: Medium Intensity | Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Ed arm participants with high adherence during 3 month main intervention period were randomized to either low or medium intensity maintenance. This arm consists of Ed participants with high adherence randomized to medium intensity maintenance. | 0 | 14 | 0 | 14 | 7 | 14 |
| EG008 | Period 2: Ed Low Adherence: Medium Intensity | Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Ed arm participants with low adherence during 3 month main intervention period were randomized to either medium or high intensity maintenance. This arm consists of Ed participants with low adherence randomized to medium intensity maintenance. | 0 | 14 | 0 | 14 | 8 | 14 |
| EG009 | Period 2: Ed Low Adherence: High Intensity | Participants randomized to the period 1 Ed arm received instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet had approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants were 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. Ed arm participants with low adherence during 3 month main intervention period were randomized to either medium or high intensity maintenance. This arm consists of Ed participants with low adherence randomized to high intensity maintenance. | 0 | 16 | 0 | 16 | 7 | 16 |
| EG010 | Period 2: Ed+MBI n/a (Assessment Only) | This group consists of Ed+MBI participants who were not re-randomized for maintenance phase because they dropped out of the intervention, but may have continued to complete assessments including adverse event reporting. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG011 | Period 2: Ed n/a (Assessment Only) | This group consists of Ed participants who were not re-randomized for maintenance phase because they dropped out of the intervention, but may have continued to complete assessments including adverse event reporting. | 1 | 4 | 0 | 4 | 0 | 4 |
| Hypercholesterolemia | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | Total cholesterol CTCAE grade increase of 1 or more from baseline |
|
| Hypertriglyceridemia | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment | CTCAE grade increase of 1 of more over time |
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| Other | General disorders | CTCAE (Unspecified) | Systematic Assessment | Other adverse events reported by participants |
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Not provided
Not provided
| D004700 | Endocrine System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |