Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes
NCT ID: NCT03037528
Last Updated: 2023-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2017-01-27
2021-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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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
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.
positive affect informational materials
Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.
mindfulness informational materials
Participants will be taught about mindfulness and mindful eating techniques.
dietary tracking
Participants will be asked to track their diet consistently.
Mindfulness, Tracking
Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program.
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.
mindfulness informational materials
Participants will be taught about mindfulness and mindful eating techniques.
dietary tracking
Participants will be asked to track their diet consistently.
Positive Affect, Tracking
Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program.
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.
positive affect informational materials
Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.
dietary tracking
Participants will be asked to track their diet consistently.
Tracking
Participants will be asked to actively track what they eat in addition to receiving the core program.
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.
dietary tracking
Participants will be asked to track their diet consistently.
Positive Affect, Mindfulness
Participants will receive information about positive affect and mindfulness in addition to the core program.
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.
positive affect informational materials
Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.
mindfulness informational materials
Participants will be taught about mindfulness and mindful eating techniques.
Positive Affect
Participants will receive information about positive affect in addition to the core program.
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.
positive affect informational materials
Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.
Mindfulness
Participants will receive information about mindfulness in addition to the core program.
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.
mindfulness informational materials
Participants will be taught about mindfulness and mindful eating techniques.
No Extras
Participants will receive the core program.
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.
Interventions
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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.
positive affect informational materials
Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.
mindfulness informational materials
Participants will be taught about mindfulness and mindful eating techniques.
dietary tracking
Participants will be asked to track their diet consistently.
Eligibility Criteria
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Inclusion Criteria
* Current HbA1c of 6.5% or higher
* Regular access to the internet
Exclusion Criteria
* 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
21 Years
70 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Michigan
OTHER
Responsible Party
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Laura Saslow
Assistant Professor
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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Saslow LR, Missel AL, O'Brien A, Kim S, Hecht FM, Moskowitz JT, Bayandorian H, Pietrucha M, Raymond K, Richards B, Liestenfeltz B, Mason AE, Daubenmier J, Aikens JE. Psychological Support Strategies for Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Randomized Controlled Trial. JMIR Diabetes. 2023 May 11;8:e44295. doi: 10.2196/44295.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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HUM00115537
Identifier Type: -
Identifier Source: org_study_id
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