Diabetes Type 2, Overweight or Obesity
Conditions
Keywords
Health app, Diet, Exercise, Sleep
Brief summary
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
BEHAVIORALApp
Access to the app during the 12 week period following randomization
Sponsors
Yale University
Thrive AI Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTMelinda Irwin
PRINCIPAL_INVESTIGATORMelinda Irwin
Yale University
Outcome results
None listed