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

University of Michigan

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: mindfulness informational materials; Behavioral: positive affect informational materials; Behavioral: diet and lifestyle program; Behavioral: dietary tracking

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03037528

HUM00115537

5K01DK107456-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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112 participants in 8 patient groups

Positive Affect, Mindfulness, Tracking

Experimental group

Description:

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

Treatment:

Behavioral: dietary tracking

Behavioral: diet and lifestyle program

Behavioral: positive affect informational materials

Behavioral: mindfulness informational materials

Mindfulness, Tracking

Experimental group

Description:

Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program.

Treatment:

Behavioral: dietary tracking

Behavioral: diet and lifestyle program

Behavioral: mindfulness informational materials

Positive Affect, Tracking

Experimental group

Description:

Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program.

Treatment:

Behavioral: dietary tracking

Behavioral: diet and lifestyle program

Behavioral: positive affect informational materials

Tracking

Experimental group

Description:

Participants will be asked to actively track what they eat in addition to receiving the core program.

Treatment:

Behavioral: dietary tracking

Behavioral: diet and lifestyle program

Positive Affect, Mindfulness

Experimental group

Description:

Participants will receive information about positive affect and mindfulness in addition to the core program.

Treatment:

Behavioral: diet and lifestyle program

Behavioral: positive affect informational materials

Behavioral: mindfulness informational materials

Positive Affect

Experimental group

Description:

Participants will receive information about positive affect in addition to the core program.

Treatment:

Behavioral: diet and lifestyle program

Behavioral: positive affect informational materials

Mindfulness

Experimental group

Description:

Participants will receive information about mindfulness in addition to the core program.

Treatment:

Behavioral: diet and lifestyle program

Behavioral: mindfulness informational materials

No Extras

Experimental group

Description:

Participants will receive the core program.

Treatment:

Behavioral: diet and lifestyle program