Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT03037528
- Lead Sponsor
- University of Michigan
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- Weight: Body Mass Index of 25-45 kg/m2 or greater.
- Current HbA1c of 6.5% or higher
- Regular access to the internet
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Glycemic Control 12 months Measured with HbA1c
- Secondary Outcome Measures
Name Time Method 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.
Weight Loss 12 months Measured with percent change in body weight
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Michigan🇺🇸Ann Arbor, Michigan, United States