Diabetes Type 2NCT07376655
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
A study testing App in people with Diabetes Type 2 and Overweight or Obesity, run by Yale University at 1 site in United States.
Trial summary
The goals of this randomized trial is to learn: 1. If the Thrive AI Health app will help adults improve their everyday habits (diet, exercise, and sleep). 2. How often participants will use the Thrive AI Health app to which they will have free access The Thrive AI Health app uses artificial intelligence (AI) to give… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2, Overweight or Obesity
- What is being tested?
- App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at high risk for chronic disease defined as:
- Body mass index (BMI)>25
- BMI<=25 who are prediabetic or have type 2 diabetes
- Aged 40 years or older
Who cannot join
- Unable to walk
Trial locations and contacts
1 site in 1 country.
About this study
The goals of this randomized trial is to learn:
- If the Thrive AI Health app will help adults improve their everyday habits (diet, exercise, and sleep).
- How often participants will use the Thrive AI Health app to which they will have free access
The Thrive AI Health app uses artificial intelligence (AI) to give personalized advice. It is designed to help people eat better, exercise more, manage stress, and sleep well.
Researchers will compare changes in diet, exercise and sleep in participants using the app to those participants not using the app.
Participants will complete study questionnaires and an in-person visit at the beginning and end of the study.
Read the detailed description
After consenting to participate in the study, adults who are overweight, have obesity, prediabetes, or type II diabetes will complete online questionnaires and attend an in-person visit.
The questionnaires measure:
Diet; Physical activity; Sleep quality; Quality of life
During the visit, the following will be measured or performed:
Height; Weight; Blood pressure; Blood sample collection; 6-minute walk test
Participants will then be randomly assigned to one of two groups:
- Thrive AI Health app intervention group. The Thrive AI Health app uses artificial intelligence (AI) to give personalized advice. It is designed to help people eat better, exercise more, manage stress, and sleep well.
- Wait-list control group
Those in the intervention group will be give a Fitbit which will by synched with the app.
After 12 weeks, participants will complete the questionnaires and clinic visit assessments again.
Following the 12-week assessments, those in the wait-list group will gain access to the Thrive AI Health app for 12 weeks and will complete online questionnaires at the 24-week mark.
When participants in the wait-list group gain access to the app, they will also start wearing a Fitbit, which will be linked to the app.
- Conditions
- Diabetes Type 2, Overweight or Obesity
- Being tested
- App
- Keywords
- Health app, Diet, Exercise, Sleep
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppBehavioural
Access to the app during the 12 week period following randomization
| Study group | Role | What they receive |
|---|---|---|
| Thrive AI Health app | Experimental | Access to the Thrive AI Health app Receives: Behavioral: App |
| Wait list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Self-reported minutes per week of moderate-vigorous-intensity physical activity will be estimated using the Modifiable Physical Activity Questionnaire. A higher number of minutes of moderate-vigorous-intensity physical activity per week means a better outcome.
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Healthy Eating Index
Healthy Eating Index will be will be estimated using the self-reported food frequency questionnaire developed by Fred Hutchinson Cancer Center. The range for the Healthy Eating Index is 0-100. The higher number mean the better outcome
Measured: Baseline to 12 weeks
Sleep quality
Self-reported sleep quality estimated using the Pittsburgh Sleep Quality Index (PSQI). Sleep will be assessed at baseline and 12-weeks using the PSQI, which is a widely used measure of subjective sleep disturbance; its validity and reliability have been established in various populations. Score range 0-21 with a lower score indicating better sleep.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start4 Jun 2026
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrive AI Health
- Responsible party
- Sponsor
- Investigators
- Melinda Irwin, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376655
- Sponsor's protocol ID
- 2000040743
- Status last verified
- Oct 2026
- First submitted
- 10 Dec 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
- ClinicalTrials.gov ID
- NCT07376655
- Acronym / sponsor ID
- 2000040743
- Conditions
- Diabetes Type 2, Overweight or Obesity
- Keywords
- Health app, Diet, Exercise, Sleep
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Thrive AI Health
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- 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 goals of this randomized trial is to learn:
- If the Thrive AI Health app will help adults improve their everyday habits (diet, exercise, and sleep).
- How often participants will use the Thrive AI Health app to which they will have free access
The Thrive AI Health app uses artificial intelligence (AI) to give personalized advice. It is designed to help people eat better, exercise more, manage stress, and sleep well.
Researchers will compare changes in diet, exercise and sleep in participants using the app to those participants not using the app.
Participants will complete study questionnaires and an in-person visit at the beginning and end of the study.
Detailed description
After consenting to participate in the study, adults who are overweight, have obesity, prediabetes, or type II diabetes will complete online questionnaires and attend an in-person visit.
The questionnaires measure:
Diet; Physical activity; Sleep quality; Quality of life
During the visit, the following will be measured or performed:
Height; Weight; Blood pressure; Blood sample collection; 6-minute walk test
Participants will then be randomly assigned to one of two groups:
- Thrive AI Health app intervention group. The Thrive AI Health app uses artificial intelligence (AI) to give personalized advice. It is designed to help people eat better, exercise more, manage stress, and sleep well.
- Wait-list control group
Those in the intervention group will be give a Fitbit which will by synched with the app.
After 12 weeks, participants will complete the questionnaires and clinic visit assessments again.
Following the 12-week assessments, those in the wait-list group will gain access to the Thrive AI Health app for 12 weeks and will complete online questionnaires at the 24-week mark.
When participants in the wait-list group gain access to the app, they will also start wearing a Fitbit, which will be linked to the app.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrive AI Health app | Experimental | Behavioral: AppAccess to the Thrive AI Health app |
| Wait list control | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at high risk for chronic disease defined as:
- Body mass index (BMI)>25
- BMI<=25 who are prediabetic or have type 2 diabetes
- Aged 40 years or older
Key exclusion criteria (1 listed)
- Unable to walk
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 |
|---|---|---|
| AppAccess to the app during the 12 week period following randomization | Behavioural | Thrive AI Health app |
Primary outcome
Physical activity
Time frame: Baseline to 12 weeks
Self-reported minutes per week of moderate-vigorous-intensity physical activity will be estimated using the Modifiable Physical Activity Questionnaire. A higher number of minutes of moderate-vigorous-intensity physical activity per week means a better outcome.
2 secondary outcomes
Healthy Eating Index
Time frame: Baseline to 12 weeks
Sleep quality
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Melinda Irwin principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App in people with Diabetes Type 2 and Overweight or Obesity, run by Yale University 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 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Physical activity (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.