Testing Responses of Young Adults to Intervention Messages for Promoting Physical Activity Trial

NCT ID: NCT05794178

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2026-11-30

Brief Summary

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The goal of this clinical trial is to test a precision (person-specific and context-sensitive) messaging algorithm for increasing physical activity and slowing weight gain in insufficiently-active young adults. The main questions it aims to answer are:

* Does physical activity increase more when text messages are sent based on a precision rule for selecting and timing messages compared to when the same message content is selected and sent at random or not at all?
* Do biological or social characteristics of young adults make them more likely to respond positively to the precision messaging intervention than either of the other two interventions?

Participants will be provided with education about health-enhancing physical activity and given an activity tracker to wear for 12 months. They will then be randomly assigned to one of three groups. Participants in one group (Precision AIM) will receive up to 4 messages/day selected and timed based on a person-specific algorithm that forecasts possible message effects periodically throughout the day. Messages will be drawn from one of three content libraries: move more, sit less, or inspirational quotes. Participants in a second group (Random AIM) will receive 4 messages/day selected at random from the same three content libraries and delivered at random times within their availability window. Participants in the third group (No AIM) will receive not motivational messages but will randomly assigned to the Random AIM group will receive up to 4 messages/day drawn at random from three content libraries at randomly-selected times. Step counts and weight will be assessed at baseline, and at 3 months, 6 months, 12 months, and 18 months. Researchers will compare Precision AIM, Random AIM and No AIM groups to see if physical activity increased more and weight gain was slower in Precision AIM than Random AIM or No AIM after 3, 6, and 12 months of intervention, and 6 months after the intervention is complete (18 months).

Detailed Description

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Conditions

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Physical Inactivity Weight Gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Precision AIM

Education + activity monitor + up to 4 text messages/day, each drawn from one of 3 content libraries and timed based on a person- and context-specific algorithm that will be updated monthly based on incoming data (within a participant-defined availability window)

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

Education about health benefits of physical activity, 2018 US Physical Activity Guidelines, assigned goals tailored to baseline step counts, and worksheet to develop action and coping plans (three of each)

Activity tracker

Intervention Type BEHAVIORAL

Fitbit activity tracker and mobile app to provide ad libitum behavioral feedback and self-regulatory support

Text messaging (precision dosing)

Intervention Type BEHAVIORAL

Up to four text messages/day within a participant's availability window, timed and selected from one of three content libraries (move more, sit less, inspirational quotes) based on a person-specific dynamic model and contextual data

Random AIM

Education + activity monitor + up to 4 text messages/day, each drawn from one of 3 content libraries and timed at random (within a participant-defined availability window).

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

Education about health benefits of physical activity, 2018 US Physical Activity Guidelines, assigned goals tailored to baseline step counts, and worksheet to develop action and coping plans (three of each)

Activity tracker

Intervention Type BEHAVIORAL

Fitbit activity tracker and mobile app to provide ad libitum behavioral feedback and self-regulatory support

Text messaging (random timing and selection)

Intervention Type BEHAVIORAL

Four text messages/day at random times within a participant's availability window and drawn at random from one of three content libraries (move more \[40%\], sit less \[40%\], inspirational quotes \[20%\])

No AIM

Education + activity monitor

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

Education about health benefits of physical activity, 2018 US Physical Activity Guidelines, assigned goals tailored to baseline step counts, and worksheet to develop action and coping plans (three of each)

Activity tracker

Intervention Type BEHAVIORAL

Fitbit activity tracker and mobile app to provide ad libitum behavioral feedback and self-regulatory support

Interventions

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Education

Education about health benefits of physical activity, 2018 US Physical Activity Guidelines, assigned goals tailored to baseline step counts, and worksheet to develop action and coping plans (three of each)

Intervention Type BEHAVIORAL

Activity tracker

Fitbit activity tracker and mobile app to provide ad libitum behavioral feedback and self-regulatory support

Intervention Type BEHAVIORAL

Text messaging (random timing and selection)

Four text messages/day at random times within a participant's availability window and drawn at random from one of three content libraries (move more \[40%\], sit less \[40%\], inspirational quotes \[20%\])

Intervention Type BEHAVIORAL

Text messaging (precision dosing)

Up to four text messages/day within a participant's availability window, timed and selected from one of three content libraries (move more, sit less, inspirational quotes) based on a person-specific dynamic model and contextual data

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* own an iPhone or Android smartphone that they would be willing to download the Fitbit app onto and sync with a Fitbit tracker and a custom, AIM app
* willing to wear a Fitbit tracker almost continually (23.5 hours/day) for a 12- month period of time
* free of visual impairment that would interfere with the receipt of text messages on their phone
* capable of reading, speaking and understanding English and of giving informed consent
* willing to complete a full 18-month study protocol

Exclusion Criteria

* self-report sufficient aerobic activity to meet 2018 Physical Activity Guidelines for American adults
* research-grade accelerometer records sufficient aerobic physical activity to meet 2018 Physical Activity Guidelines for American adults
* living outside the continental US
* one or more contraindications to physical activity
* require an assistive device for mobility or have any other condition that may limit or prevent participation in moderate-intensity physical activity
* pregnant or planning to become pregnant within the next 12 months
* prior diagnosis of cancer, cardiovascular disease, diabetes or metabolic syndrome
* concurrent participation in another research study involving physical activity or weight loss
* planning to have surgery or relocate outside the continental US within the next year.
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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David Conroy

Bickner Chair of Kinesiology and Professor of Kinesiology, School of Kinesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David E Conroy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Constantino M Lagoa, PhD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

The Pennsylvania State University

University Park, Pennsylvania, United States

Site Status COMPLETED

Countries

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United States

Central Contacts

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Ann Mehringer

Role: CONTACT

734-647-6050

Facility Contacts

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David E Conroy, PhD

Role: primary

734-647-8404

Ann Mehringer

Role: backup

734-647-6050

Other Identifiers

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R33HL164868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00019311

Identifier Type: -

Identifier Source: org_study_id

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