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| Name | Class |
|---|---|
| Thrive AI Health | UNKNOWN |
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The goals of this randomized trial is to learn:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thrive AI Health app | Experimental | Access to the Thrive AI Health app |
|
| Wait list control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App | Behavioral | Access to the app during the 12 week period following randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity | 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. | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Healthy Eating Index | 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 | Baseline to 12 weeks |
| Sleep quality |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index | Body mass index (wt/height squared) will be calculated using measured height and weight. | Baseline to 12 weeks |
| Aerobic capacity | The widely used 6 minute walk test developed by the American Thoracic Society in 2002, will be used to assess aerobic capacity. |
Inclusion Criteria:
Body mass index (BMI)>25
BMI<=25 who are prediabetic or have type 2 diabetes
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melinda Irwin | Contact | 203-785-6392 | melinda.irwin@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melinda Irwin | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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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. |
| Baseline to 12 weeks |
| Baseline to 12 weeks |
| Physical quality of life score | 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. | Baseline to 12 weeks |
| Mental quality of life score | 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. | Baseline to 12 weeks |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |