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

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.

• App (Behavioral): Access to the app during the 12 week period following randomization

Primary outcomes

• Physical activity [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

• Healthy Eating Index [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
• Sleep quality [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

• Body mass index [Baseline to 12 weeks]: Body mass index (wt/height squared) will be calculated using measured height and weight.
• Aerobic capacity [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.
• Physical quality of life score [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.
• Mental quality of life score [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.

Sex: All, ages: 40 Years to any, accepts healthy volunteers

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

• Melinda Irwin, Principal investigator, Yale University