Diabetes Mellitus, Type 2NCT02676648
Web-Delivered Interventions for Blood Sugar Control for Individuals With Type 2 Diabetes
A study testing Multicomponent online program, Breath meter and Text messages in people with Diabetes Mellitus, Type 2, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Multicomponent online program, Breath meter and Text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 15 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- overweight or obese
- English-speaking
- diagnosis of type 2 diabetes (HbA1c > 6.5%)
- regular access to the internet and text messages
Who cannot join
- taking diabetes medications other than metformin
- being pregnant or breastfeeding
- currently undergoing cancer treatments
- untreated serious mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Multicomponent online program, Breath meter, Text messages, Diet-appropriate foods and cookbooks
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent online programBehavioural
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.
Breath meterBehavioural
We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.
Text messagesBehavioural
We will send participants text messages, to support intervention adherence.
Diet-appropriate foods and cookbooksBehavioural
We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Condition 1 | Experimental | 1) core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks Receives: Behavioral: Multicomponent online program; Behavioral: Breath meter; Behavioral: Text messages; Behavioral: Diet-appropriate foods and cookbooks |
| Experimental: Condition 2 | Experimental | 1) core program Receives: Behavioral: Multicomponent online program |
| Experimental: Condition 3 | Experimental | 1) core program; 2) breath meter Receives: Behavioral: Multicomponent online program; Behavioral: Breath meter |
| Experimental: Condition 4 | Experimental | 1) core program; 2) text messages Receives: Behavioral: Multicomponent online program; Behavioral: Text messages |
| Experimental: Condition 5 | Experimental | 1) core program; 2) diet-appropriate food and cookbooks Receives: Behavioral: Multicomponent online program; Behavioral: Diet-appropriate foods and cookbooks |
| Experimental: Condition 6 | Experimental | 1) core program; 2) breath meter; 3) text messages Receives: Behavioral: Multicomponent online program; Behavioral: Breath meter; Behavioral: Text messages |
| Experimental: Condition 7 | Experimental | 1) core program; 2) breath meter; 3) diet-appropriate food and cookbooks Receives: Behavioral: Multicomponent online program; Behavioral: Breath meter; Behavioral: Diet-appropriate foods and cookbooks |
| Experimental: Condition 8 | Experimental | 1) core program; 3) text messages; 4) diet-appropriate food and cookbooks Receives: Behavioral: Multicomponent online program; Behavioral: Text messages; Behavioral: Diet-appropriate foods and cookbooks |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change in HbA1c from baseline to 12 months post baseline
Measured: 12 months
Secondary outcomes (1)
Body Weight Percent Lost
Change in body weight percentage from baseline to 12 months post baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Saslow, University of Michigan
- Investigators
- Laura Saslow, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676648
- Sponsor's protocol ID
- HUM00102827
- Status last verified
- Aug 2021
- First submitted
- 3 Feb 2016
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 32902391
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Web-Delivered Interventions for Blood Sugar Control for Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02676648
- Acronym / sponsor ID
- HUM00102827
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Experimental: Condition 1 | Experimental | Behavioral: Multicomponent online program, Behavioral: Breath meter, Behavioral: Text messages, Behavioral: Diet-appropriate foods and cookbooks1) core program; 2) breath meter; 3) text messages; 4) diet-appropriate food and cookbooks |
| Experimental: Condition 2 | Experimental | Behavioral: Multicomponent online program1) core program |
| Experimental: Condition 3 | Experimental | Behavioral: Multicomponent online program, Behavioral: Breath meter1) core program; 2) breath meter |
| Experimental: Condition 4 | Experimental | Behavioral: Multicomponent online program, Behavioral: Text messages1) core program; 2) text messages |
| Experimental: Condition 5 | Experimental | Behavioral: Multicomponent online program, Behavioral: Diet-appropriate foods and cookbooks1) core program; 2) diet-appropriate food and cookbooks |
| Experimental: Condition 6 | Experimental | Behavioral: Multicomponent online program, Behavioral: Breath meter, Behavioral: Text messages1) core program; 2) breath meter; 3) text messages |
| Experimental: Condition 7 | Experimental | Behavioral: Multicomponent online program, Behavioral: Breath meter, Behavioral: Diet-appropriate foods and cookbooks1) core program; 2) breath meter; 3) diet-appropriate food and cookbooks |
| Experimental: Condition 8 | Experimental | Behavioral: Multicomponent online program, Behavioral: Text messages, Behavioral: Diet-appropriate foods and cookbooks1) core program; 3) text messages; 4) diet-appropriate food and cookbooks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- overweight or obese
- English-speaking
- diagnosis of type 2 diabetes (HbA1c > 6.5%)
- regular access to the internet and text messages
Key exclusion criteria (4 listed)
- taking diabetes medications other than metformin
- being pregnant or breastfeeding
- currently undergoing cancer treatments
- untreated serious mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent online programThe 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. | Behavioural | Experimental: Condition 1, Experimental: Condition 2, Experimental: Condition 3, Experimental: Condition 4, Experimental: Condition 5, Experimental: Condition 6, Experimental: Condition 7, Experimental: Condition 8 |
| Breath meterWe will send participants a breath meter to test ketones in their breath, to assess dietary adherence. | Behavioural | Experimental: Condition 1, Experimental: Condition 3, Experimental: Condition 6, Experimental: Condition 7 |
| Text messagesWe will send participants text messages, to support intervention adherence. | Behavioural | Experimental: Condition 1, Experimental: Condition 4, Experimental: Condition 6, Experimental: Condition 8 |
| Diet-appropriate foods and cookbooksWe will send participants diet-appropriate foods and cookbooks, to support intervention adherence. | Behavioural | Experimental: Condition 1, Experimental: Condition 5, Experimental: Condition 7, Experimental: Condition 8 |
Primary outcome
HbA1c
Time frame: 12 months
Change in HbA1c from baseline to 12 months post baseline
1 secondary outcome
Body Weight Percent Lost
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Background: PubMed 32902391Saslow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Saslow, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent online program, Breath meter and Text messages in people with Diabetes Mellitus, Type 2, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02676648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.