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)
112
1
8
52.2
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
  • 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:

Study Results

No Results Posted as of Jun 24, 2021