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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: diet and lifestyle program; Behavioral: positive affect informational materials; Behavioral: mindfulness informational materials; Behavioral: dietary tracking

• Registration Number: NCT03037528
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-01-27
• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Results First Submitted: 2022-06-01
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-07
• Last Update Submitted: 2023-10-07
• Results First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Positive Affect, Tracking	dietary tracking	Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program.
Tracking	diet and lifestyle program	Participants will be asked to actively track what they eat in addition to receiving the core program.
Tracking	dietary tracking	Participants will be asked to actively track what they eat in addition to receiving the core program.
Mindfulness, Tracking	dietary tracking	Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program.
Positive Affect, Tracking	diet and lifestyle program	Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program.
Positive Affect, Mindfulness	positive affect informational materials	Participants will receive information about positive affect and mindfulness in addition to the core program.
Positive Affect	diet and lifestyle program	Participants will receive information about positive affect in addition to the core program.
Mindfulness	mindfulness informational materials	Participants will receive information about mindfulness in addition to the core program.
Positive Affect, Tracking	positive affect informational materials	Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program.
Positive Affect, Mindfulness, Tracking	diet and lifestyle program	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
Positive Affect, Mindfulness, Tracking	positive affect informational materials	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
Positive Affect, Mindfulness	diet and lifestyle program	Participants will receive information about positive affect and mindfulness in addition to the core program.
Positive Affect	positive affect informational materials	Participants will receive information about positive affect in addition to the core program.
Mindfulness	diet and lifestyle program	Participants will receive information about mindfulness in addition to the core program.
No Extras	diet and lifestyle program	Participants will receive the core program.
Positive Affect, Mindfulness, Tracking	mindfulness informational materials	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
Positive Affect, Mindfulness, Tracking	dietary 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
Mindfulness, Tracking	diet and lifestyle program	Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program.
Mindfulness, Tracking	mindfulness informational materials	Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program.
Positive Affect, Mindfulness	mindfulness informational materials	Participants will receive information about positive affect and mindfulness in addition to the core program.

Primary Outcome Measures

Name	Time	Method
Glycemic Control	12 months	Measured with HbA1c

Secondary Outcome Measures

Name	Time	Method
Depressive Symptoms	12 months	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.
Weight Loss	12 months	Measured with percent change in body weight

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States