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| ID | Type | Description | Link |
|---|---|---|---|
| 5K01DK107456-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of the research is to optimize an online and mobile multicomponent 12-month diet and lifestyle intervention for improving the blood glucose control of individuals with type 2 diabetes.
The core of the program, administered to all participants, includes recommendations to follow a very low carbohydrate, ketogenic diet. The researchers will test whether adding the following experimental components will enhance the intervention's ability to improve health outcomes: (1) active vs. periodic self-monitoring of dietary intake using an "app"; (2) training vs. no training in positive affect; and (3) training vs. no training in mindfulness and mindful eating.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Affect, Mindfulness, Tracking | Experimental | Participants will receive information about positive affect and mindfulness, in addition to being asked to actively track what they eat and receiving the core program |
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| Mindfulness, Tracking | Experimental | Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program. |
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| Positive Affect, Tracking | Experimental | Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program. |
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| Tracking | Experimental | Participants will be asked to actively track what they eat in addition to receiving the core program. |
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| Positive Affect, Mindfulness |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diet and lifestyle program | Behavioral | Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control | Measured with HbA1c | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Measured with percent change in body weight | 12 months |
| Depressive Symptoms | Measured with Patient Health Questionnaire-8. Eight items, each of which is scored 0 to 3, for a 0 to 24 severity score, with higher being a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37166961 | Derived | Saslow LR, Missel AL, O'Brien A, Kim S, Hecht FM, Moskowitz JT, Bayandorian H, Pietrucha M, Raymond K, Richards B, Liestenfeltz B, Mason AE, Daubenmier J, Aikens JE. Psychological Support Strategies for Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Randomized Controlled Trial. JMIR Diabetes. 2023 May 11;8:e44295. doi: 10.2196/44295. |
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In this 2x2x2 design, rather than considering this as an 8-arm trial, we consider this a trial assessing 3 factors at two levels, and we compare each of the 3 factors, rather than comparing the study arms.
We recruited 112 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Positive Affect, Mindfulness, and Daily Tracking | Participants were assigned to Positive affect, Mindfulness, and Daily Tracking |
| FG001 | Mindfulness and Daily Tracking | Participants were assigned to Mindfulness and Daily Tracking |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 26, 2017 |
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| Experimental |
Participants will receive information about positive affect and mindfulness in addition to the core program. |
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| Positive Affect | Experimental | Participants will receive information about positive affect in addition to the core program. |
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| Mindfulness | Experimental | Participants will receive information about mindfulness in addition to the core program. |
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| No Extras | Experimental | Participants will receive the core program. |
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| positive affect informational materials | Behavioral | Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. |
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| mindfulness informational materials | Behavioral | Participants will be taught about mindfulness and mindful eating techniques. |
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| dietary tracking | Behavioral | Participants will be asked to track their diet consistently. |
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| 12 months |
| FG002 | Positive Affect and Daily Tracking | Participants were assigned to Positive Affect and Daily Tracking |
| FG003 | Daily Tracking | Participants were assigned to Daily Tracking |
| FG004 | Positive Affect, Mindfulness, Monthly Tracking | Participants were assigned to Positive Affect, Mindfulness, Monthly Tracking |
| FG005 | Mindfulness and Monthly Tracking | Participants were assigned to Mindfulness and Monthly Tracking |
| FG006 | Positive Affect and Monthly Tracking | Participants were assigned to Positive Affect and Monthly Tracking |
| FG007 | Monthly Tracking | Participants were assigned to Monthly Tracking |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Positive Affect, Mindfulness, and Daily Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. Positive Affect, Mindfulness, and Daily Tracking: positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (daily): Participants will be asked to track their diet daily. |
| BG001 | Mindfulness and Daily Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (daily): Participants will be asked to track their diet daily. |
| BG002 | Positive Affect and Daily Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. dietary tracking (daily): Participants will be asked to track their diet daily. |
| BG003 | Daily Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (daily): Participants will be asked to track their diet daily. |
| BG004 | Positive Affect, Mindfulness, Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly. |
| BG005 | Mindfulness and Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly. |
| BG006 | Positive Affect and Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. dietary tracking (monthly): Participants will be asked to track their diet monthly. |
| BG007 | Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (monthly): Participants will be asked to track their diet monthly. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Glycemic Control | Measured with HbA1c | Posted | Mean | Standard Deviation | change in units of percents | 12 months |
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| Secondary | Weight Loss | Measured with percent change in body weight | Posted | Mean | Standard Deviation | change in percent | 12 months |
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| Secondary | Depressive Symptoms | Measured with Patient Health Questionnaire-8. Eight items, each of which is scored 0 to 3, for a 0 to 24 severity score, with higher being a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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The entire course of the trial (12 months).
This was a low-risk trial.
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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 | Positive Affect, Mindfulness, and Daily Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (daily): Participants will be asked to track their diet daily. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG001 | Mindfulness and Daily Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (daily): Participants will be asked to track their diet daily. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Positive Affect and Daily Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. dietary tracking (daily): Participants will be asked to track their diet daily. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG003 | Daily Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (daily): Participants will be asked to track their diet daily. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG004 | Positive Affect, Mindfulness, Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG005 | Mindfulness and Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG006 | Positive Affect and Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. dietary tracking (monthly): Participants will be asked to track their diet monthly. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG007 | Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (monthly): Participants will be asked to track their diet monthly. | 0 | 13 | 0 | 13 | 0 | 13 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Saslow | University of Michigan | (734) 764-7836 | saslowl@umich.edu |
| Mar 14, 2023 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| African American |
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| Other |
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| Superiority |
| t-test, 2 sided | .457 | Superiority |
| t-test, 2 sided | .580 | Superiority |
| t-test, 2 sided | .275 | Superiority |
| t-test, 2 sided | .001 | Superiority |
| t-test, 2 sided | .007 | Superiority |
| t-test, 2 sided | .142 | Superiority |
| OG003 | Daily Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (daily): Participants will be asked to track their diet daily. |
| OG004 | Positive Affect, Mindfulness, Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly. |
| OG005 | Mindfulness and Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly. |
| OG006 | Positive Affect and Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. dietary tracking (monthly): Participants will be asked to track their diet monthly. |
| OG007 | Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (monthly): Participants will be asked to track their diet monthly. |
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Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.
positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.
dietary tracking (daily): Participants will be asked to track their diet daily.
| OG003 | Daily Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (daily): Participants will be asked to track their diet daily. |
| OG004 | Positive Affect, Mindfulness, Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly. |
| OG005 | Mindfulness and Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. mindfulness informational materials (yes): Participants will be taught about mindfulness and mindful eating techniques. dietary tracking (monthly): Participants will be asked to track their diet monthly. |
| OG006 | Positive Affect and Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. positive affect informational materials (yes): Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. dietary tracking (monthly): Participants will be asked to track their diet monthly. |
| OG007 | Monthly Tracking | Diet and Lifestyle Program: Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. dietary tracking (monthly): Participants will be asked to track their diet monthly. |
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