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

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ClinicalTrials.gov Identifier: NCT03037528
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Laura Saslow, University of Michigan

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 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 144 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 : January 27, 2017
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Glycemic Control [ Time Frame: 12 months ]
    Measured with HbA1c


Secondary Outcome Measures :
  1. Weight Loss [ Time Frame: 12 months ]
    Measured with percent body weight lost

  2. Depressive symptoms [ Time Frame: 12 months ]
    Measured with Patient Health Questionnaire-8



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037528


Contacts
Contact: Laura Saslow, PhD (734) 764-7836 info@succeedstudy.org

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Laura Saslow, PhD       info@succeedstudy.org   
Sponsors and Collaborators
University of Michigan

Responsible Party: Laura Saslow, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03037528     History of Changes
Other Study ID Numbers: HUM00115537
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases