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

Yale University logo

Yale University

Status

Not yet enrolling

Conditions

Overweight or Obesity
Diabetes Type 2

Treatments

Behavioral: App

Study type

Interventional

Funder types

Other

Identifiers

NCT07376655
2000040743

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

40+ years old

Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Thrive AI Health app
Experimental group
Description:
Access to the Thrive AI Health app
Treatment:
Behavioral: App
Wait list control
No Intervention group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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