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

NCT05794178 | Recruiting

• 2 other identifiers: STUDY00019311R33HL164868
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Physical Inactivity; Weight Gain

Outcome Measures

Primary Outcomes (1)

• Average daily step counts (6 months)

  Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period

  Change from baseline to 6 months

Secondary Outcomes (14)

• Average daily step counts (12 months)

  Change from baseline to 12 months

• Average daily step counts (18 months)

  Change from 12 months to 18 months

• Weight (6 months)

  Change from baseline to 6 months

• Weight (12 months)

  Change from baseline to 12 months

• Weight (18 months)

  Change from 12 months to 18 months

Study Arms (3)

Precision AIM

EXPERIMENTAL

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)

Behavioral: Education; Behavioral: Activity tracker; Behavioral: Text messaging (precision dosing)

Random AIM

ACTIVE COMPARATOR

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).

Behavioral: Education; Behavioral: Activity tracker; Behavioral: Text messaging (random timing and selection)

No AIM

ACTIVE COMPARATOR

Education + activity monitor

Behavioral: Education; Behavioral: Activity tracker

Interventions

Education 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)

No AIM; Precision AIM; Random AIM

Activity tracker BEHAVIORAL

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

No AIM; Precision AIM; Random AIM

Text messaging (random timing and selection) 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 \[20%\])

Random AIM

Text messaging (precision dosing) 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

Precision AIM

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

COMPLETED

MeSH Terms

Conditions

Sedentary Behavior; Weight Gain

Interventions

Educational Status; Fitness Trackers

Condition Hierarchy (Ancestors)

Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• David E Conroy, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Constantino M Lagoa, PhD

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Mehringer

CONTACT

734-647-6050; amehring@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bickner Chair of Kinesiology and Professor of Kinesiology, School of Kinesiology

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: March 31, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (2)