CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 51 enrolled
Drug / intervention
Companionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04827212
NCT04827212Early Ph 1Completed

An Integrated Two-Way Communication and Near-Real-Time Sensing System to Detect and Modify Daily Inactivity Among Adults Over Age 60

Northeastern University·interventional·Posted Apr 1, 2021·Updated Jul 3, 2024

In Brief

A Early Phase 1 clinical trial evaluating Companion for Exercise and Physical Activity. Completed, enrolled 51 participants across 1 site.

Detailed Summary

This pilot study is a small sample (N=46) 16-week clinical trial with a follow-up after 24-weeks among sedentary adults \>60 y with a BMI \>25 kg/m2 to tests the impact of a hybrid artificial intelligence behavior change system (Companion) on physical activity. Participants will be randomized to a control and intervention group. All participants will engage in a proven supervised exercise program from week 1 to 16. Only the intervention group will receive Companion from week 1 to 16.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
20222023202420252026
First PostedApr 1, 2021
Enrollment StartMar 16, 2021
Primary CompletionNov 2, 2022
Study CompletionDec 13, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.3 years ago

Interventions

Companionbehavioral

Companion integrates wearable sensing with the smartphone to develop a behavior-aware, virtual system that uses a "human-in-the-loop" approach to enable meaningful two-way communication. Companion builds rich models of typical behavior using sensors and context sensitive ecological momentary assessment to deliver intervention components and behavior change strategies using socially engaging, contextually salient, and tailored text-message conversations in near-real-time.