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 research will identify the most promising intervention components. The following components will be tested: dietary adherence testing with a breath meter, text messages, and diet-appropriate foods and cookbooks. The primary goal is to optimize the intervention by examining the HbA1c results at 12 months.
Interventions
BEHAVIORALMulticomponent online program
The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence.
BEHAVIORALBreath meter
We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.
BEHAVIORALText messages
We will send participants text messages, to support intervention adherence.
BEHAVIORALDiet-appropriate foods and cookbooks
We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* overweight or obese * English-speaking * diagnosis of type 2 diabetes (HbA1c \> 6.5%) * regular access to the internet and text messages
Exclusion criteria
* taking diabetes medications other than metformin * being pregnant or breastfeeding * currently undergoing cancer treatments * untreated serious mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 months | Change in HbA1c from baseline to 12 months post baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight Percent Lost | 12 months | Change in body weight percentage from baseline to 12 months post baseline |
Countries
United States
Outcome results
None listed