Web-Delivered Interventions for Blood Sugar Control for Individuals With Type 2 Diabetes
NCT ID: NCT02676648
Last Updated: 2021-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2016-02-29
2017-11-15
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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Experimental: Condition 1
1\) core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks
Multicomponent online program
The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence.
Breath meter
We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.
Text messages
We will send participants text messages, to support intervention adherence.
Diet-appropriate foods and cookbooks
We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.
Experimental: Condition 2
1\) core program
Multicomponent online program
The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence.
Experimental: Condition 3
1\) core program; 2) breath meter
Multicomponent online program
The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence.
Breath meter
We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.
Experimental: Condition 4
1\) core program; 2) text messages
Multicomponent online program
The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence.
Text messages
We will send participants text messages, to support intervention adherence.
Experimental: Condition 5
1\) core program; 2) diet-appropriate food and cookbooks
Multicomponent online program
The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence.
Diet-appropriate foods and cookbooks
We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.
Experimental: Condition 6
1\) core program; 2) breath meter; 3) text messages
Multicomponent online program
The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence.
Breath meter
We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.
Text messages
We will send participants text messages, to support intervention adherence.
Experimental: Condition 7
1\) core program; 2) breath meter; 3) diet-appropriate food and cookbooks
Multicomponent online program
The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence.
Breath meter
We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.
Diet-appropriate foods and cookbooks
We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.
Experimental: Condition 8
1\) core program; 3) text messages; 4) diet-appropriate food and cookbooks
Multicomponent online program
The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence.
Text messages
We will send participants text messages, to support intervention adherence.
Diet-appropriate foods and cookbooks
We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.
Interventions
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Multicomponent online program
The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence.
Breath meter
We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.
Text messages
We will send participants text messages, to support intervention adherence.
Diet-appropriate foods and cookbooks
We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.
Eligibility Criteria
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Inclusion Criteria
* English-speaking
* diagnosis of type 2 diabetes (HbA1c \> 6.5%)
* regular access to the internet and text messages
Exclusion Criteria
* being pregnant or breastfeeding
* currently undergoing cancer treatments
* untreated serious mental illness
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Laura Saslow
Assistant Professor
Principal Investigators
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Laura Saslow, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
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, Moskowitz JT, Mason AE, Daubenmier J, Liestenfeltz B, Missel AL, Bayandorian H, Aikens JE, Kim S, Hecht FM. Intervention Enhancement Strategies Among Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Evaluating the Impact With a Randomized Trial. JMIR Diabetes. 2020 Sep 9;5(3):e15835. doi: 10.2196/15835.
Other Identifiers
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HUM00102827
Identifier Type: -
Identifier Source: org_study_id
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