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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Multicomponent online program; Behavioral: Breath meter; Behavioral: Text messages; Behavioral: Diet-appropriate foods and cookbooks

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Laura Saslow, PhD, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): November 15, 2017
• Study Completion (Actual): November 15, 2017

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HUM00102827

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO