Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALdiet and lifestyle program
Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.
BEHAVIORALpositive affect informational materials
Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.
BEHAVIORALmindfulness informational materials
Participants will be taught about mindfulness and mindful eating techniques.
BEHAVIORALdietary tracking
Participants will be asked to track their diet consistently.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Weight: Body Mass Index of 25-45 kg/m2 or greater. * Current HbA1c of 6.5% or higher * Regular access to the internet
Exclusion criteria
* Taking glucose lowering medications other than metformin * Being pregnant or breastfeeding * Currently undergoing cancer treatments * Active use of a weight loss program or medications * Self-reported impaired renal or hepatic function * Self-reported untreated thyroid condition * Vegetarian or vegan * Weight loss surgery within the past year * Medical concerns that prevent participants from following the assigned protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control | 12 months | Measured with HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 12 months | Measured with percent change in body weight |
| Depressive Symptoms | 12 months | 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. |
Countries
United States
Participant flow
Recruitment details
We recruited 112 participants.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| 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. | 13 |
| 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. | 14 |
| 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. | 13 |
| 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. | 14 |
| 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. | 15 |
| 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. | 13 |
| Total | 112 |
Baseline characteristics
| Characteristic | Positive Affect, Mindfulness, and Daily Tracking | Total | Monthly Tracking | Positive Affect and Monthly Tracking | Mindfulness and Monthly Tracking | Positive Affect, Mindfulness, Monthly Tracking | Daily Tracking | Positive Affect and Daily Tracking | Mindfulness and Daily Tracking |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 10.7 | 54.1 years STANDARD_DEVIATION 9.6 | 53.0 years STANDARD_DEVIATION 11.1 | 58.0 years STANDARD_DEVIATION 7 | 55.9 years STANDARD_DEVIATION 9.6 | 55.9 years STANDARD_DEVIATION 6.6 | 54.9 years STANDARD_DEVIATION 11 | 53.4 years STANDARD_DEVIATION 11.3 | 50.2 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 111 Participants | 13 Participants | 14 Participants | 14 Participants | 13 Participants | 14 Participants | 13 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African American | 4 Participants | 27 Participants | 4 Participants | 5 Participants | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 6 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 11 Participants | 81 Participants | 9 Participants | 9 Participants | 13 Participants | 9 Participants | 11 Participants | 9 Participants | 10 Participants |
| Sex: Female, Male Female | 11 Participants | 83 Participants | 10 Participants | 11 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 11 Participants |
| Sex: Female, Male Male | 4 Participants | 29 Participants | 3 Participants | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 13 | 0 / 14 | 0 / 13 | 0 / 14 | 0 / 15 | 0 / 13 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 13 | 0 / 14 | 0 / 13 | 0 / 14 | 0 / 15 | 0 / 13 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 13 | 0 / 14 | 0 / 13 | 0 / 14 | 0 / 15 | 0 / 13 |
Outcome results
Primary
Glycemic Control
Measured with HbA1c
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Affect, Mindfulness, and Daily Tracking | Glycemic Control | -.46 change in units of percents | Standard Deviation 1.2 |
| Mindfulness and Daily Tracking | Glycemic Control | -.93 change in units of percents | Standard Deviation 1.14 |
| Positive Affect and Daily Tracking | Glycemic Control | -.46 change in units of percents | Standard Deviation 1.99 |
| Daily Tracking | Glycemic Control | -.23 change in units of percents | Standard Deviation 1.27 |
| Positive Affect, Mindfulness, Monthly Tracking | Glycemic Control | -1.23 change in units of percents | Standard Deviation 2.93 |
| Mindfulness and Monthly Tracking | Glycemic Control | -1.34 change in units of percents | Standard Deviation 0.61 |
| Positive Affect and Monthly Tracking | Glycemic Control | -.58 change in units of percents | Standard Deviation 0.48 |
| Monthly Tracking | Glycemic Control | -.64 change in units of percents | Standard Deviation 0.78 |
p-value: 0.214t-test, 2 sided
p-value: 0.017t-test, 2 sided
p-value: 0.457t-test, 2 sided
p-value: 0.58t-test, 2 sided
p-value: 0.275t-test, 2 sided
p-value: 0.001t-test, 2 sided
p-value: 0.007t-test, 2 sided
p-value: 0.142t-test, 2 sided
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Affect, Mindfulness, and Daily Tracking | Depressive Symptoms | -2.50 units on a scale | Standard Deviation 3.12 |
| Mindfulness and Daily Tracking | Depressive Symptoms | -2.70 units on a scale | Standard Deviation 2.26 |
| Positive Affect and Daily Tracking | Depressive Symptoms | -4.00 units on a scale | Standard Deviation 7.67 |
| Daily Tracking | Depressive Symptoms | 0.00 units on a scale | Standard Deviation 1.9 |
| Positive Affect, Mindfulness, Monthly Tracking | Depressive Symptoms | -3.38 units on a scale | Standard Deviation 4 |
| Mindfulness and Monthly Tracking | Depressive Symptoms | -3.71 units on a scale | Standard Deviation 4.39 |
| Positive Affect and Monthly Tracking | Depressive Symptoms | -5.86 units on a scale | Standard Deviation 6.15 |
| Monthly Tracking | Depressive Symptoms | -4.60 units on a scale | Standard Deviation 3.78 |
p-value: 0.018t-test, 2 sided
p-value: 0.004t-test, 2 sided
p-value: 0.134t-test, 2 sided
p-value: 1t-test, 2 sided
p-value: 0.048t-test, 2 sided
p-value: 0.066t-test, 2 sided
p-value: 0.045t-test, 2 sided
p-value: 0.053t-test, 2 sided
Secondary
Weight Loss
Measured with percent change in body weight
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Affect, Mindfulness, and Daily Tracking | Weight Loss | -5.69 change in percent | Standard Deviation 8.03 |
| Mindfulness and Daily Tracking | Weight Loss | -9.60 change in percent | Standard Deviation 7.16 |
| Positive Affect and Daily Tracking | Weight Loss | -10.00 change in percent | Standard Deviation 14.8 |
| Daily Tracking | Weight Loss | -5.25 change in percent | Standard Deviation 5.94 |
| Positive Affect, Mindfulness, Monthly Tracking | Weight Loss | -9.14 change in percent | Standard Deviation 8.33 |
| Mindfulness and Monthly Tracking | Weight Loss | -9.85 change in percent | Standard Deviation 11.28 |
| Positive Affect and Monthly Tracking | Weight Loss | -10.05 change in percent | Standard Deviation 10.27 |
| Monthly Tracking | Weight Loss | -3.84 change in percent | Standard Deviation 4.92 |
p-value: 0.027t-test, 2 sided
p-value: 0t-test, 2 sided
p-value: 0.054t-test, 2 sided
p-value: 0.014t-test, 2 sided
p-value: 0.019t-test, 2 sided
p-value: 0.026t-test, 2 sided
p-value: 0.013t-test, 2 sided
p-value: 0.163t-test, 2 sided