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Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes

Not Applicable
Completed
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
Glycemic Control12 months

Measured with HbA1c

Secondary Outcome Measures
NameTimeMethod
Depressive Symptoms12 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 Loss12 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

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