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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037528
• Other study ID #: HUM00115537
• Secondary ID: 5K01DK107456-05
• Status: Completed
• Phase: N/A
• Start date: January 27, 2017
• Est. completion date: June 4, 2021

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 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
Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.
• mindfulness informational materials
Participants will be taught about mindfulness and mindful eating techniques.
• dietary tracking
Participants will be asked to track their diet consistently.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control	Measured with HbA1c	12 months
Secondary	Weight Loss	Measured with percent change in body weight	12 months
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.	12 months