NCT07376655

Brief Summary

The goals of this randomized trial is to learn:

  1. 1.If the Thrive AI Health app will help adults improve their everyday habits (diet, exercise, and sleep).
  2. 2.How often participants will use the Thrive AI Health app to which they will have free access

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

December 10, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 30, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

December 10, 2025

Last Update Submit

March 25, 2026

Conditions

Diabetes Type 2Overweight or Obesity

Keywords

Health appDietExerciseSleep

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Healthy Eating Index

    Baseline to 12 weeks

  • Sleep quality

    Baseline to 12 weeks

Other Outcomes (4)

  • Body mass index

    Baseline to 12 weeks

  • Aerobic capacity

    Baseline to 12 weeks

  • Physical quality of life score

    Baseline to 12 weeks

  • +1 more other outcomes

Study Arms (2)

Thrive AI Health app

EXPERIMENTAL

Access to the Thrive AI Health app

Behavioral: App

Wait list control

NO INTERVENTION

Interventions

AppBEHAVIORAL

Access to the app during the 12 week period following randomization

Thrive AI Health app

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to walk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesityMotor Activity

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Melinda Irwin

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melinda Irwin

CONTACT

203-785-6392melinda.irwin@yale.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 10, 2025

First Posted

January 29, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)