Digital Messaging Interventions for Physical Activity Promotion

(TRY AIM Trial)

Overseen by Constantino M Lagoa, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Penn State University

Disqualifiers: Sufficient aerobic activity, Cancer, Cardiovascular disease, Diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on physical activity and messaging interventions, so it's unlikely that your medications would be affected, but you should confirm with the trial organizers.

What data supports the effectiveness of the treatment Digital Messaging Interventions for Physical Activity Promotion?

Research shows that text messaging can effectively remind people to attend appointments, stick to treatments, and manage their health better. Text messages are widely accepted and have shown early success in changing health behaviors, suggesting they could help promote physical activity too. ^{1 2 3 4 5}

Is text messaging for health interventions safe?

Research shows that using text messaging for health interventions is generally safe, with no reports of adverse events like misreading data or privacy issues. It is a cost-effective and widely used method to support behavior change and health management. ^{1 6 7 8 9}

How does the Digital Messaging Interventions for Physical Activity Promotion treatment differ from other treatments?

This treatment is unique because it uses text messaging to promote physical activity, leveraging the widespread use of cell phones and the low cost of sending messages. It includes personalized message timing and selection, which may enhance its effectiveness compared to standard, non-personalized approaches. ^{10 11 12 13 14}

Research Team

David E Conroy, PhD

Principal Investigator

The Pennsylvania State University

Constantino M Lagoa, PhD

Principal Investigator

The Pennsylvania State University

Eligibility Criteria

This trial is for young adults with a sedentary lifestyle who own a smartphone, are willing to wear an activity tracker almost all day for 12 months, and can read and understand English. It's not for those living outside the continental US, pregnant or planning pregnancy within a year, diagnosed with certain diseases, involved in other related studies, meeting current physical activity guidelines or unable to do moderate exercise.

Inclusion Criteria

Free of visual impairment that would interfere with the receipt of text messages on their phone

I own a smartphone and am willing to use apps and a Fitbit for the study.

Capable of reading, speaking and understanding English and of giving informed consent

Exclusion Criteria

I need help to move around or have a condition that stops me from doing moderate exercise.

One or more contraindications to physical activity

Self-report sufficient aerobic activity to meet 2018 Physical Activity Guidelines for American adults

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants are provided with education about health-enhancing physical activity and given an activity tracker to wear for 12 months

1 week

Intervention

Participants are randomly assigned to one of three groups: Precision AIM, Random AIM, or No AIM. Precision AIM group receives up to 4 messages/day based on a person-specific algorithm, Random AIM group receives 4 messages/day at random, and No AIM group receives no messages

12 months

Follow-up

Participants are monitored for changes in physical activity and weight gain 6 months after the intervention is complete

6 months

Treatment Details

Interventions

• Activity tracker (Behavioural Intervention)
• Education (Behavioural Intervention)
• Text messaging (precision dosing) (Behavioural Intervention)
• Text messaging (random timing and selection) (Behavioural Intervention)

Trial Overview The study tests if personalized text messages based on an algorithm (Precision AIM) increase physical activity more than random messages (Random AIM) or no motivational texts at all (No AIM). Participants will use an activity tracker and receive different types of messages over a year to see which method is most effective in promoting physical activity.

Participant Groups

Group I: Precision AIM Experimental Treatment 3 Interventions

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 II: No AIM Active Control 2 Interventions

Education + activity monitor

Group III: Random AIM Active Control 3 Interventions

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).

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Lindsay A. Rosenwald

Penn State University

Chief Medical Officer since 2013

MD from Temple University School of Medicine

Scott Tarriff

Penn State University

Chief Executive Officer since 2007

B.S. in Marketing from Pennsylvania State University, MBA from Rider College

Findings from Research

This study aims to evaluate the effectiveness of different reminder methods (text messages, reminder calls, or both) in increasing the use of service referrals among 300 participants from community outreach programs.

The research will help determine how mobile phone-based interventions can enhance community engagement and service utilization, potentially guiding future reminder protocols for similar programs across the country.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Research Protocol to Test the Effectiveness of Text Messaging and Reminder Calls to Increase Service Use Referrals in a Community Engagement Program. Varma, DS., Hart, M., McIntyre, DS., et al.[2020]

Text messaging interventions for health behaviors showed good acceptance and early efficacy, with 10 out of 16 randomized controlled trials reporting significant improvements in areas like medication adherence and behavior modification.

Despite promising results, the overall evidence is limited by methodological issues, indicating that more rigorous studies are needed to draw definitive conclusions about the effectiveness of text messaging in health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the use of mobile phone text messaging in clinical and healthy behaviour interventions. Wei, J., Hollin, I., Kachnowski, S.[2022]

A review of 14 studies on SMS-based health interventions showed that 13 of them resulted in positive behavior changes, indicating that text messaging can effectively promote health behavior change.

Key features that enhanced the effectiveness of SMS interventions included the initiation of dialogue, tailored content, and interactivity, suggesting that these elements should be prioritized in future research to maximize impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior change interventions delivered by mobile telephone short-message service. Fjeldsoe, BS., Marshall, AL., Miller, YD.[2022]

A cluster randomized controlled trial involving 160 chronic patients across six hospitals showed that a Tailored Multimedia Intervention, which combined technology and personalized counseling, improved patient satisfaction with nurses' communication and enhanced self-efficacy regarding medication adherence.

The positive effects on self-efficacy were sustained even after six months, indicating that this approach can effectively support patients in managing their medication regimens over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating a synergy effect: A cluster randomized controlled trial testing the effect of a tailored multimedia intervention on patient outcomes. Linn, AJ., van Dijk, L., van Weert, JCM., et al.[2019]

A meta-analysis of 8 randomized trials involving 1994 patients found that 2-way text messaging significantly improves medication adherence compared to 1-way text messaging, with a relative risk of 1.23 versus 1.04, respectively.

The study highlights that 2-way text messaging, which includes receiving replies from patients, is more effective in ensuring patients take their medications as directed, suggesting a valuable tool for managing chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-way versus two-way text messaging on improving medication adherence: meta-analysis of randomized trials. Wald, DS., Butt, S., Bestwick, JP.[2022]

A total of 124 SMS text messages were developed to support diet and exercise behavior change after a diabetes prevention program, using the Behaviour Change Wheel framework to ensure they were theory-based and effective.

After evaluation by 18 participants, 61.3% of the messages were refined for clarity and relevance, resulting in a final bank of 120 messages that were well-received by both users and coaches, demonstrating a structured approach to developing effective mobile health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation and Refinement of a Bank of SMS Text Messages to Promote Behavior Change Adherence Following a Diabetes Prevention Program: Survey Study. MacPherson, M., Cranston, K., Johnston, C., et al.[2021]

An interactive text messaging campaign was developed for 160 parents to support behavior change in their children as part of a childhood obesity trial, with 1-2 messages sent weekly over a year.

The intervention showed high engagement, with nearly two-thirds of parents responding to 75% or more of the text messages, indicating that text messaging is an effective tool for promoting health behavior changes among parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of an Interactive Text Messaging Campaign to Support Behavior Change in a Childhood Obesity Randomized Controlled Trial. Price, S., Ferisin, S., Sharifi, M., et al.[2022]

Text messaging is a highly effective and low-cost tool for promoting health behavior change, providing real-time support and engagement, especially in low-resource settings.

Systematic reviews show that text message interventions can significantly improve health outcomes in areas like smoking cessation, medication adherence, and self-management of chronic conditions, yet they are underutilized on a large scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Old-Fashioned Technology in the Era of "Bling": Is There a Future for Text Messaging in Health Care? Willcox, JC., Dobson, R., Whittaker, R.[2020]

In the HealthyYou text (HYTxt) program, 43% of participants dropped out, with 65% of those leaving within the first two weeks, highlighting a significant early dropout issue.

Participants with higher levels of autonomous motivation were less likely to drop out early, suggesting that enhancing this type of motivation could improve retention and effectiveness of health behavior change programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline Motivation Type as a Predictor of Dropout in a Healthy Eating Text Messaging Program. Coa, K., Patrick, H.[2018]

A study involving 45 young adults (ages 18-29) used digital messaging to promote physical activity over 6 months, analyzing 20,689 messages sent, which included affectively framed, social cognitively framed, and inspirational quotes.

The results showed that no single type of message was universally effective in promoting physical activity; individual responses varied, suggesting that future interventions should personalize message content based on individual preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Message Framing Effects on Physical Activity Dynamics in a Digital Messaging Intervention: Secondary Analysis. Lee, AM., Hojjatinia, S., Courtney, JB., et al.[2023]

Text message interventions significantly increase the number of steps taken per day, with a moderate effect size observed in a meta-analysis of 13 studies involving 1,346 participants.

While the interventions showed a positive trend in increasing moderate-to-vigorous physical activity, the results were not statistically significant, indicating that further research is needed to explore the effectiveness of different intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Message Interventions for Physical Activity: A Systematic Review and Meta-Analysis. Smith, DM., Duque, L., Huffman, JC., et al.[2021]

A total of 8 Spanish-speaking adults participated in a focus group to review and confirm the translation of motivational physical activity text messages, resulting in 22 new culturally appropriate messages added to the original database of 246.

The participants found the translated text messages meaningful and believed they could effectively motivate them to increase their walking, indicating the potential for these messages to improve physical activity among Hispanic adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilingual Text Messaging Translation: Translating Text Messages From English Into Spanish for the Text4Walking Program. Buchholz, SW., Sandi, G., Ingram, D., et al.[2023]

The TEXT ME text message intervention significantly increased recreational and travel physical activity in patients with coronary heart disease, with participants reporting 471 MET-min/week compared to 307 MET-min/week in the control group after six months.

Patients who received both the TEXT ME intervention and traditional cardiac rehabilitation were much more likely to reach target physical activity levels, with an odds ratio of 7.07 compared to 1.80 for those receiving only cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns, predictors and effects of texting intervention on physical activity in CHD - insights from the TEXT ME randomized clinical trial. Thakkar, J., Redfern, J., Thiagalingam, A., et al.[2022]

A pilot study involving 52 African American adults showed that a text message intervention significantly increased physical activity by about 8% compared to a control group of 30 participants who did not receive the messages.

The text messages, which provided strategies for increasing physical activity based on health behavior models, were well-received, indicating that this method could effectively motivate individuals to engage in more exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Messaging: An Intervention to Increase Physical Activity among African American Participants in a Faith-Based, Competitive Weight Loss Program. McCoy, P., Leggett, S., Bhuiyan, A., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A Research Protocol to Test the Effectiveness of Text Messaging and Reminder Calls to Increase Service Use Referrals in a Community Engagement Program. [2020]

2. England pubmed.ncbi.nlm.nih.gov

A review of the use of mobile phone text messaging in clinical and healthy behaviour interventions. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Behavior change interventions delivered by mobile telephone short-message service. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Creating a synergy effect: A cluster randomized controlled trial testing the effect of a tailored multimedia intervention on patient outcomes. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

One-way versus two-way text messaging on improving medication adherence: meta-analysis of randomized trials. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Evaluation and Refinement of a Bank of SMS Text Messages to Promote Behavior Change Adherence Following a Diabetes Prevention Program: Survey Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Development and Implementation of an Interactive Text Messaging Campaign to Support Behavior Change in a Childhood Obesity Randomized Controlled Trial. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Old-Fashioned Technology in the Era of "Bling": Is There a Future for Text Messaging in Health Care? [2020]

9. Canada pubmed.ncbi.nlm.nih.gov

Baseline Motivation Type as a Predictor of Dropout in a Healthy Eating Text Messaging Program. [2018]

10. Canada pubmed.ncbi.nlm.nih.gov

Motivational Message Framing Effects on Physical Activity Dynamics in a Digital Messaging Intervention: Secondary Analysis. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Text Message Interventions for Physical Activity: A Systematic Review and Meta-Analysis. [2021]

12. Canada pubmed.ncbi.nlm.nih.gov

Bilingual Text Messaging Translation: Translating Text Messages From English Into Spanish for the Text4Walking Program. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Patterns, predictors and effects of texting intervention on physical activity in CHD - insights from the TEXT ME randomized clinical trial. [2022]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Text Messaging: An Intervention to Increase Physical Activity among African American Participants in a Faith-Based, Competitive Weight Loss Program. [2023]