Background

Low physical activity is an important risk factor for common physical and mental disorders. Physical activity interventions delivered via smartphones can help users maintain and increase physical activity, but outcomes have been mixed.

Purpose

Here we assessed the effects of sending daily motivational and feedback text messages in a microrandomized clinical trial on changes in physical activity from one day to the next in a student population.

Methods

We included 93 participants who used a physical activity app, "DIAMANTE" for a period of 6 weeks. Every day, their phone pedometer passively tracked participants' steps. They were microrandomized to receive different types of motivational messages, based on a cognitive-behavioral framework, and feedback on their steps. We used generalized estimation equation models to test the effectiveness of feedback and motivational messages on changes in steps from one day to the next.

Results

Sending any versus no text message initially resulted in an increase in daily steps (729 steps, p = .012), but this effect decreased over time. A multivariate analysis evaluating each text message category separately showed that the initial positive effect was driven by the motivational messages though the effect was small and trend-wise significant (717 steps; p = .083), but not the feedback messages (-276 steps, p = .4).

Conclusion

Sending motivational physical activity text messages based on a cognitive-behavioral framework may have a positive effect on increasing steps, but this decreases with time. Further work is needed to examine using personalization and contextualization to improve the efficacy of text-messaging interventions on physical activity outcomes.

Clinicaltrials.gov identifier

NCT04440553.

Objective

Providing behavioral health interventions via smartphones allows these interventions to be adapted to the changing behavior, preferences, and needs of individuals. This can be achieved through reinforcement learning (RL), a sub-area of machine learning. However, many challenges could affect the effectiveness of these algorithms in the real world. We provide guidelines for decision-making.

Materials and methods

Using thematic analysis, we describe challenges, considerations, and solutions for algorithm design decisions in a collaboration between health services researchers, clinicians, and data scientists. We use the design process of an RL algorithm for a mobile health study "DIAMANTE" for increasing physical activity in underserved patients with diabetes and depression. Over the 1.5-year project, we kept track of the research process using collaborative cloud Google Documents, Whatsapp messenger, and video teleconferencing. We discussed, categorized, and coded critical challenges. We grouped challenges to create thematic topic process domains.

Results

Nine challenges emerged, which we divided into 3 major themes: 1. Choosing the model for decision-making, including appropriate contextual and reward variables; 2. Data handling/collection, such as how to deal with missing or incorrect data in real-time; 3. Weighing the algorithm performance vs effectiveness/implementation in real-world settings.

Conclusion

The creation of effective behavioral health interventions does not depend only on final algorithm performance. Many decisions in the real world are necessary to formulate the design of problem parameters to which an algorithm is applied. Researchers must document and evaulate these considerations and decisions before and during the intervention period, to increase transparency, accountability, and reproducibility.

Trial registration

clinicaltrials.gov, NCT03490253.

Introduction

Depression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual's behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.

Methods and analysis

In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up.

Ethics and dissemination

The Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.

Trial registration number

NCT03490253; pre-results.

ABSTRACTIntroductionDepression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual’s behavior and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.Methods and analysisIn a three-arm randomized controlled trial we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18 to 75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (PHQ-8 >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent HbA1c from medical records at baseline and at intervention completion at 6-month follow-up.Ethics and disseminationThe Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our User Designed Methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.Registrationclinicaltrials.gov: NCT03490253; pre-resultsArticle SummaryStrengths and LimitationsNovel approach of targeting diabetes and depressive symptoms using a smartphone applicationAbility to compare adaptive messaging for increasing physical activity to messages delivered with equal probabilitiesTesting of a smartphone application integrated within primary care settings in a low-income vulnerable patient populationLongitudinal design with 6-month follow-up enables assessing intervention effects over timeChallenges of this trial include supporting users in key behavior change in an automated manner with minimal in-person support