Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: App.
- Who it may be relevant to
- Registry conditions: Diabetes Type 2, Overweight or Obesity. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- Behavioral App
Access to the app during the 12 week period following randomization
Primary outcome measures
- Physical activity [Time frame: Baseline to 12 weeks]
Secondary outcome measures (2)
- Healthy Eating Index [Time frame: Baseline to 12 weeks]
- Sleep quality [Time frame: Baseline to 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Yale University — New Haven
Identifiers
NCT: NCT07376655 · 2000040743