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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: diet and lifestyle program; Behavioral: positive affect informational materials; Behavioral: mindfulness informational materials; Behavioral: dietary tracking

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive Affect, Mindfulness, Tracking; Participants will receive information about positive affect and mindfulness, in addition to being asked to actively track what they eat and receiving the core program	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.; Behavioral: positive affect informational materials; Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.; Behavioral: mindfulness informational materials; Participants will be taught about mindfulness and mindful eating techniques.; Behavioral: dietary tracking; Participants will be asked to track their diet consistently.
Experimental: Mindfulness, Tracking; Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program.	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.; Behavioral: mindfulness informational materials; Participants will be taught about mindfulness and mindful eating techniques.; Behavioral: dietary tracking; Participants will be asked to track their diet consistently.
Experimental: Positive Affect, Tracking; Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program.	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.; Behavioral: positive affect informational materials; Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.; Behavioral: dietary tracking; Participants will be asked to track their diet consistently.
Experimental: Tracking; Participants will be asked to actively track what they eat in addition to receiving the core program.	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.; Behavioral: dietary tracking; Participants will be asked to track their diet consistently.
Experimental: Positive Affect, Mindfulness; Participants will receive information about positive affect and mindfulness in addition to the core program.	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.; Behavioral: positive affect informational materials; Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.; Behavioral: mindfulness informational materials; Participants will be taught about mindfulness and mindful eating techniques.
Experimental: Positive Affect; Participants will receive information about positive affect in addition to the core program.	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.; Behavioral: positive affect informational materials; Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.
Experimental: Mindfulness; Participants will receive information about mindfulness in addition to the core program.	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.; Behavioral: mindfulness informational materials; Participants will be taught about mindfulness and mindful eating techniques.
Experimental: No Extras; Participants will receive the core program.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Control	Measured with HbA1c	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss	Measured with percent change in body weight	12 months
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2017
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): June 4, 2021

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimated): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HUM00115537; 5K01DK107456-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No