Examination of Psychological Tools and Tracking in an Online Intervention for 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 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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: diet and lifestyle program
* Behavioral: positive affect informational materials
* Behavioral: mindfulness informational materials
* Behavioral: dietary tracking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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: Positive Affect, Mindfulness, Tracking<br>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<br>* Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.<br>Behavioral: positive affect informational materials<br>* Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.<br>Behavioral: mindfulness informational materials<br>* Participants will be taught about mindfulness and mindful eating techniques.<br>Behavioral: dietary tracking<br>* Participants will be asked to track their diet consistently.<br>|
| Experimental: Mindfulness, Tracking<br>Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program. | Behavioral: diet and lifestyle program<br>* Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.<br>Behavioral: mindfulness informational materials<br>* Participants will be taught about mindfulness and mindful eating techniques.<br>Behavioral: dietary tracking<br>* Participants will be asked to track their diet consistently.<br>|
| Experimental: Positive Affect, Tracking<br>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<br>* Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.<br>Behavioral: positive affect informational materials<br>* Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.<br>Behavioral: dietary tracking<br>* Participants will be asked to track their diet consistently.<br>|
| Experimental: Tracking<br>Participants will be asked to actively track what they eat in addition to receiving the core program. | Behavioral: diet and lifestyle program<br>* Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.<br>Behavioral: dietary tracking<br>* Participants will be asked to track their diet consistently.<br>|
| Experimental: Positive Affect, Mindfulness<br>Participants will receive information about positive affect and mindfulness in addition to the core program. | Behavioral: diet and lifestyle program<br>* Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.<br>Behavioral: positive affect informational materials<br>* Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.<br>Behavioral: mindfulness informational materials<br>* Participants will be taught about mindfulness and mindful eating techniques.<br>|
| Experimental: Positive Affect<br>Participants will receive information about positive affect in addition to the core program. | Behavioral: diet and lifestyle program<br>* Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.<br>Behavioral: positive affect informational materials<br>* Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.<br>|
| Experimental: Mindfulness<br>Participants will receive information about mindfulness in addition to the core program. | Behavioral: diet and lifestyle program<br>* Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.<br>Behavioral: mindfulness informational materials<br>* Participants will be taught about mindfulness and mindful eating techniques.<br>|
| Experimental: No Extras<br>Participants will receive the core program. | Behavioral: diet and lifestyle program<br>* Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control | Measured with HbA1c | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Measured with percent change in body weight | 12 months | 
| Depressive Symptoms | Measured with Patient Health Questionnaire-8. Eight items, each of which is scored 0 to 3, for a 0 to 24 severity score, with higher being a worse outcome. | 12 months |