Diabetes Mellitus, Type 2NCT03037528
Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes
A study testing diet and lifestyle program, positive affect informational materials and mindfulness informational materials 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 21 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- diet and lifestyle program, positive affect informational materials and mindfulness informational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2017to 4 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Weight: Body Mass Index of 25-45 kg/m2 or greater.
- Current HbA1c of 6.5% or higher
- Regular access to the internet
Who cannot join
- 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
Show all 9Show fewer
- Vegetarian or vegan
- Weight loss surgery within the past year
- Medical concerns that prevent participants from following the assigned protocol
Trial locations and contacts
1 site in 1 country.
About this study
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 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- diet and lifestyle program, positive affect informational materials, mindfulness informational materials, dietary tracking
- 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.
diet and lifestyle programBehavioural
Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.
positive affect informational materialsBehavioural
Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.
mindfulness informational materialsBehavioural
Participants will be taught about mindfulness and mindful eating techniques.
dietary trackingBehavioural
Participants will be asked to track their diet consistently.
| Study group | Role | What they receive |
|---|---|---|
| Positive Affect, Mindfulness, Tracking | Experimental | 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 Receives: Behavioral: diet and lifestyle program; Behavioral: positive affect informational materials; Behavioral: mindfulness informational materials; Behavioral: dietary tracking |
| Mindfulness, Tracking | Experimental | Participants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program. Receives: Behavioral: diet and lifestyle program; Behavioral: mindfulness informational materials; Behavioral: dietary tracking |
| Positive Affect, Tracking | Experimental | Participants will receive information about positive affect, be asked to actively track what they eat, and receive the core program. Receives: Behavioral: diet and lifestyle program; Behavioral: positive affect informational materials; Behavioral: dietary tracking |
| Tracking | Experimental | Participants will be asked to actively track what they eat in addition to receiving the core program. Receives: Behavioral: diet and lifestyle program; Behavioral: dietary tracking |
| Positive Affect, Mindfulness | Experimental | Participants will receive information about positive affect and mindfulness in addition to the core program. Receives: Behavioral: diet and lifestyle program; Behavioral: positive affect informational materials; Behavioral: mindfulness informational materials |
| Positive Affect | Experimental | Participants will receive information about positive affect in addition to the core program. Receives: Behavioral: diet and lifestyle program; Behavioral: positive affect informational materials |
| Mindfulness | Experimental | Participants will receive information about mindfulness in addition to the core program. Receives: Behavioral: diet and lifestyle program; Behavioral: mindfulness informational materials |
| No Extras | Experimental | Participants will receive the core program. Receives: Behavioral: diet and lifestyle program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
Measured with HbA1c
Measured: 12 months
Secondary outcomes (2)
Weight Loss
Measured with percent change in body weight
Measured: 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.
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 posted31 Jan 2017 (estimated)
- Study start27 Jan 2017
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 112 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037528
- Sponsor's protocol ID
- HUM00115537
- Other IDs
- 5K01DK107456-05
- Status last verified
- Oct 2023
- First submitted
- 27 Jan 2017
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saslow LR, Missel AL, O'Brien A, Kim S, Hecht FM, Moskowitz JT, Bayandorian H, Pietrucha M, Raymond K, Richards B, Liestenfeltz B, Mason AE, Daubenmier J, Aikens JE. Psychological Support Strategies for Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Randomized Controlled Trial. JMIR Diabetes. 2023 May 11;8:e44295. doi: 10.2196/44295.
PubMed 37166961
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03037528
- Acronym / sponsor ID
- HUM00115537
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 7 Nov 2023
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Positive Affect, Mindfulness, Tracking | Experimental | Behavioral: diet and lifestyle program, Behavioral: positive affect informational materials, Behavioral: mindfulness informational materials, Behavioral: dietary trackingParticipants 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 | Experimental | Behavioral: diet and lifestyle program, Behavioral: mindfulness informational materials, Behavioral: dietary trackingParticipants will receive information about mindfulness, be asked to actively track what they eat, and receive the core program. |
| Positive Affect, Tracking | Experimental | Behavioral: diet and lifestyle program, Behavioral: positive affect informational materials, Behavioral: dietary trackingParticipants will receive information about positive affect, be asked to actively track what they eat, and receive the core program. |
| Tracking | Experimental | Behavioral: diet and lifestyle program, Behavioral: dietary trackingParticipants will be asked to actively track what they eat in addition to receiving the core program. |
| Positive Affect, Mindfulness | Experimental | Behavioral: diet and lifestyle program, Behavioral: positive affect informational materials, Behavioral: mindfulness informational materialsParticipants will receive information about positive affect and mindfulness in addition to the core program. |
| Positive Affect | Experimental | Behavioral: diet and lifestyle program, Behavioral: positive affect informational materialsParticipants will receive information about positive affect in addition to the core program. |
| Mindfulness | Experimental | Behavioral: diet and lifestyle program, Behavioral: mindfulness informational materialsParticipants will receive information about mindfulness in addition to the core program. |
| No Extras | Experimental | Behavioral: diet and lifestyle programParticipants will receive the core program. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Weight: Body Mass Index of 25-45 kg/m2 or greater.
- Current HbA1c of 6.5% or higher
- Regular access to the internet
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| diet and lifestyle programParticipants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. | Behavioural | Mindfulness, Mindfulness, Tracking, No Extras, Positive Affect, Positive Affect, Mindfulness, Positive Affect, Mindfulness, Tracking, Positive Affect, Tracking, Tracking |
| positive affect informational materialsParticipants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths. | Behavioural | Positive Affect, Positive Affect, Mindfulness, Positive Affect, Mindfulness, Tracking, Positive Affect, Tracking |
| mindfulness informational materialsParticipants will be taught about mindfulness and mindful eating techniques. | Behavioural | Mindfulness, Mindfulness, Tracking, Positive Affect, Mindfulness, Positive Affect, Mindfulness, Tracking |
| dietary trackingParticipants will be asked to track their diet consistently. | Behavioural | Mindfulness, Tracking, Positive Affect, Mindfulness, Tracking, Positive Affect, Tracking, Tracking |
Primary outcome
Glycemic Control
Time frame: 12 months
Measured with HbA1c
2 secondary outcomes
Weight Loss
Time frame: 12 months
Depressive Symptoms
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37166961Saslow LR, Missel AL, O'Brien A, Kim S, Hecht FM, Moskowitz JT, Bayandorian H, Pietrucha M, Raymond K, Richards B, Liestenfeltz B, Mason AE, Daubenmier J, Aikens JE. Psychological Support Strategies for Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Randomized Controlled Trial. JMIR Diabetes. 2023 May 11;8:e44295. doi: 10.2196/44295.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet and lifestyle program, positive affect informational materials and mindfulness informational materials 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 3 inclusion and 9 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 7 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycemic Control (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 NCT03037528, 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 7 Nov 2023.