CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 82 enrolled
Drug / intervention
Short Message with Text and Optional Imagebehavioral
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/NCT03907683
NCT03907683Phase 1Completed

Phase 1 Clinical Trial to Develop a Personalized Adaptive Text Message Intervention Using Control Systems Engineering Tools to Increase Physical Activity in Early Adulthood

Penn State University·interventional·Posted Apr 9, 2019·Updated Nov 4, 2022

In Brief

A Phase 1 clinical trial evaluating Short Message with Text and Optional Image for Cardiovascular Risk Factor. Completed, enrolled 82 participants across 1 site.

Detailed Summary

Our goal is to develop personalized decision rules for selecting the frequency, timing, and content of messages to promote physical activity. The objective of this project is to develop personalized dynamical models of physical activity (PA) under different weather and temporal conditions as well as in response to different types of intervention messages. This approach relies on having extensive observations within the person under varying conditions to develop a dynamical model of how different conditions interact with each other to predict how behavior changes in response to text messages. Complementary sub-models will be estimated for each participant to describe their behavioral responses under different weather conditions. Healthy but insufficiently active young adults (n=80) will wear an activity monitor and receive a variety of randomly-timed and randomly-selected notifications via smartphone. GPS coordinates at the time of messages delivery and receipt are recorded and used to look up weather indices at that location at that time. The work is exploratory/descriptive as we will be developing models to describe participants' responses to messages under different weather conditions. This work is needed to develop the decision rules for a subsequent behavioral intervention that will be developed and tested in a future project.

Study Details

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

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedApr 9, 2019
Enrollment StartApr 3, 2019
Primary CompletionJul 21, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.2 years ago

Interventions

Short Message with Text and Optional Imagebehavioral

Messages can be up to 256 characters of text and with or without an image. "Move more" and "sit less" messages were written to target established cognitive and affective constructs associated with physical activity (e.g., prompts to action plan, guidance for maximizing pleasure by regulating intensity).