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.

Study Timeline

• Study Start: 2017-01-27
• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Results First Submitted: 2022-06-01
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-07
• Last Update Submitted: 2023-10-07
• Results First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

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

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