Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life

March 25, 2026 updated by: Melinda Irwin, Yale University

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 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  1. 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.
  2. 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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • 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 Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Unable to walk

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Wait list control
Experimental: Thrive AI Health app
Access to the Thrive AI Health app
Behavioral: App
Access to the app during the 12 week period following randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthy Eating Index
Time Frame: Baseline to 12 weeks
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
Baseline to 12 weeks
Sleep quality
Time Frame: Baseline to 12 weeks
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.
Baseline to 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: Baseline to 12 weeks
Body mass index (wt/height squared) will be calculated using measured height and weight.
Baseline to 12 weeks
Aerobic capacity
Time Frame: Baseline to 12 weeks
The widely used 6 minute walk test developed by the American Thoracic Society in 2002, will be used to assess aerobic capacity.
Baseline to 12 weeks
Physical quality of life score
Time Frame: Baseline to 12 weeks
36-item Short Form Survey (SF-36) will be used to generate the Physical Component Summary (PCS). Using norm based scores, above 50 indicate a better-than-average physical health-related quality of life.
Baseline to 12 weeks
Mental quality of life score
Time Frame: Baseline to 12 weeks
36-item Short Form Survey (SF-36) will be used to generate the Mental Component Summary (MCS). Using norm based scores, above 50 indicate a better-than-average mental health-related quality of life.
Baseline to 12 weeks

Collaborators and Investigators

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

Sponsor

Yale University

Collaborators

Thrive AI Health

Investigators

  • Principal Investigator: Melinda Irwin, Yale University

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000040743

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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