Web-Delivered Interventions for Blood Sugar Control for Individuals With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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The research will identify the most promising intervention components. The following components will be tested: dietary adherence testing with a breath meter, text messages, and diet-appropriate foods and cookbooks. The primary goal is to optimize the intervention by examining the HbA1c results at 12 months.

Official Title
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Randomized Trial of Web-Delivered Interventions for Blood Sugar Control for Individuals With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Multicomponent online program
* Behavioral: Breath meter
* Behavioral: Text messages
* Behavioral: Diet-appropriate foods and cookbooks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overweight or obese English-speaking diagnosis of type 2 diabetes (HbA1c > 6.5%) regular access to the internet and text messages Exclusion Criteria: taking diabetes medications other than metformin being pregnant or breastfeeding currently undergoing cancer treatments untreated serious mental illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Condition 1<br>1) core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks | Behavioral: Multicomponent online program<br>* 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.<br>Behavioral: Breath meter<br>* We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.<br>Behavioral: Text messages<br>* We will send participants text messages, to support intervention adherence.<br>Behavioral: Diet-appropriate foods and cookbooks<br>* We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.<br>|
| Experimental: Experimental: Condition 2<br>1) core program | Behavioral: Multicomponent online program<br>* 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.<br>|
| Experimental: Experimental: Condition 3<br>1) core program; 2) breath meter | Behavioral: Multicomponent online program<br>* 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.<br>Behavioral: Breath meter<br>* We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.<br>|
| Experimental: Experimental: Condition 4<br>1) core program; 2) text messages | Behavioral: Multicomponent online program<br>* 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.<br>Behavioral: Text messages<br>* We will send participants text messages, to support intervention adherence.<br>|
| Experimental: Experimental: Condition 5<br>1) core program; 2) diet-appropriate food and cookbooks | Behavioral: Multicomponent online program<br>* 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.<br>Behavioral: Diet-appropriate foods and cookbooks<br>* We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.<br>|
| Experimental: Experimental: Condition 6<br>1) core program; 2) breath meter; 3) text messages | Behavioral: Multicomponent online program<br>* 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.<br>Behavioral: Breath meter<br>* We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.<br>Behavioral: Text messages<br>* We will send participants text messages, to support intervention adherence.<br>|
| Experimental: Experimental: Condition 7<br>1) core program; 2) breath meter; 3) diet-appropriate food and cookbooks | Behavioral: Multicomponent online program<br>* 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.<br>Behavioral: Breath meter<br>* We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.<br>Behavioral: Diet-appropriate foods and cookbooks<br>* We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.<br>|
| Experimental: Experimental: Condition 8<br>1) core program; 3) text messages; 4) diet-appropriate food and cookbooks | Behavioral: Multicomponent online program<br>* 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.<br>Behavioral: Text messages<br>* We will send participants text messages, to support intervention adherence.<br>Behavioral: Diet-appropriate foods and cookbooks<br>* We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change in HbA1c from baseline to 12 months post baseline | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight Percent Lost | Change in body weight percentage from baseline to 12 months post baseline | 12 months |