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NCT Number: NCT07376655

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

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.

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Key information

Conditions

Diabetes Type 2 Behavior Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06520, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App

Behavioral

Access to the app during the 12 week period following randomization

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Other outcomes

  1. Body mass index

    Time frame: Baseline to 12 weeks

    Body mass index (wt/height squared) will be calculated using measured height and weight.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melinda Irwin

CONTACT

[email protected]

203-785-6392

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Thrive AI Health

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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