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

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03037528
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 8
• Actual Duration (Months): 52.2
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: diet and lifestyle program; Behavioral: positive affect informational materials; Behavioral: mindfulness informational materials; Behavioral: dietary tracking	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes
• Actual Study Start Date: Jan 27, 2017
• Actual Primary Completion Date: Jun 4, 2021
• Actual Study Completion Date: Jun 4, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Glycemic Control [12 months]

   Measured with HbA1c

Secondary Outcome Measures

1. Weight Loss [12 months]

   Measured with percent body weight lost

2. Depressive symptoms [12 months]

   Measured with Patient Health Questionnaire-8

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laura Saslow, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT03037528
• Other Study ID Numbers: HUM00115537
• First Posted: Jan 31, 2017
• Last Update Posted: Jun 24, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 24, 2021