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

August 6, 2021 updated by: Laura Saslow, University of Michigan

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 12 months
Change in HbA1c from baseline to 12 months post baseline
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Weight Percent Lost
Time Frame: 12 months
Change in body weight percentage from baseline to 12 months post baseline
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura Saslow, PhD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00102827

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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