Miro-randomized Trial for Optimizing a JITAI to Reduce Dietary Lapses in Obesity Treatment
Miro-randomized Trial for Optimizing a JITAI to Reduce Dietary Lapses in Obesity Treatment
This project targets dietary lapses (instances of nonadherence to dietary goals), a major
 cause of poor outcomes during behavioral obesity treatment, which is a recommended first-line
 intervention for cardiovascular disease. The investigators propose to conduct a
 micro-randomized trial (MRT) to empirically optimize a smartphone-based just-in-time adaptive
 intervention (JITAI) that monitors risk and intervenes on lapses as needed. By evaluating the
 immediate, proximal effect of four theory-driven interventions on lapse behavior, the project
 will: (a) produce a scalable, finalized JITAI that has the greatest potential to show clear
 clinical impact in future trials; and (b) inform the development of more sophisticated
 theoretical models of adherence behavior more broadly. Therefore, this study has three goals.
 First the investigators aim to compare the effects of delivering any intervention to no
 intervention on the occurrence of lapse. Second, the investigators aim to compare the effects
 of specific theory-driven interventions to one another to determine which ones are best for
 preventing lapses. Within this second aim, the investigators also aim to examine other
 factors that may influence the effectiveness of interventions (e.g., time, location). Lastly,
 the investigators will use the data from this MRT to customize intervention delivery in
 future versions of this JITAI

 Patients will be recruited through various methods including advertisements in local media,
 targeted online advertising, advertisements in medical and minority communities, and direct
 mailers. All participants will receive a well-established 3-month online obesity treatment
 program, with 3 months of no-treatment follow-up. In conjunction, they will use a
 smartphone-based JITAI consisting of: 1) repeated daily surveys assess lapses and relevant
 triggers; 2) a machine learning algorithm that uses information from the surveys to determine
 real-time lapse risk; & 3) interventions to counter lapse risk. When an individual is at risk
 for lapsing she will be randomly assigned to no intervention, a generic risk alert, or one of
 4 theory-driven interventions with interactive skills training. The outcome of interest will
 be the occurrence (or lack thereof) of dietary lapse, as measured both subjectively (i.e.,
 reported by the participant in the daily surveys) and objectively (i.e., via wrist-based
 intake monitoring), in the hours following randomization initiated by heightened lapse risk.
The purpose of the 6-month micro-randomized Trial (MRT) is to optimize a just-in-time
 adaptive intervention (JITAI) for dietary lapses by evaluating the effects of 4 theory-driven
 interventions on the proximal outcome of dietary lapse as compared to active and inactive
 comparators. The proposed JITAI has been extensively piloted, and will now be executed using
 a well-known NIH-funded mobile platform (PiLR Health). Prior to commencement of the main
 trial, a small group of participants will be recruited to iteratively pilot the
 below-described procedures for 3 months. These data are for piloting/testing only and will
 not be used in the analysis of primary outcomes. Participants in the main trial (N=159) will
 receive 3 months of online behavioral obesity treatment (BOT) + JITAI followed by 3 months of
 JITAI-only. The MRT includes sequential randomization to intervention options each time the
 JITAI identifies heightened lapse risk. The primary outcome is dietary lapse (assessed via
 repeated surveys called ecological momentary assessments [EMA]). The secondary outcome is
 objectively-measured eating characteristics (via wrist-watch device at assessments). The
 investigators will also assess contextual moderators (i.e., location, time of day, active
 BOT/follow-up, trigger type) for the study's exploratory aim. JITAI engagement, satisfaction,
 and weight will be used for descriptive purposes.

 Participants will be recruited on a rolling basis (~6-7 participants/month) until the target
 N=159 is reached. Participants will be recruited via advertisements in local media (e.g.
 newspapers, radio) and targeted online advertising (e.g., Google AdWords); flyers and
 advertisements posted in waiting rooms and exam rooms in primary care offices, informational
 materials made available as part of the health and wellness program for employees in the
 Lifespan heath system and hospital network (an approach used in a previous trials); and
 direct mailings. Minority participation will be increased via ads in newspapers with high
 circulation in minority communities. Recruitment flyers will also be sent to agencies serving
 minority groups. The investigators will use online advertisements on local websites that are
 popular with men and minority groups. The investigators consistently find that these
 approaches maximize minority and male recruitment.

 All following procedures described will be offered both in-person at the research center, or
 remotely via the video chat forum Zoom. The remote option is in response to the COVID-19
 pandemic. Participants who choose to attend in-person assessments will use self-report
 screening procedures consistent with hospital policy to ensure that the participant has not
 been recently or is currently ill. Rigorous sanitization procedures will be used for
 equipment and office space pre- and post-assessment.

 Interested individuals will be initially screened for eligibility via REDCap, a Lifespan
 secure website. If a participant appears to be eligible based on their survey responses, they
 will receive a follow-up call from the research team to confirm eligibility, describe the
 study in more detail, and schedule an orientation meeting. If they are not eligible, they
 will receive a message indicating that they are not eligible for the study and directed to
 contact us if they wish to receive referrals for other weight loss programs. Those who are
 eligible will be invited to an orientation, either in-person at the research center or via
 the online video chat forum Zoom, where the study will be described and informed consent
 obtained. Individuals who decide to complete the orientation via Zoom will be sent a consent
 form to their home address before the call. Only after the consent form is signed and
 returned will any further study procedures be completed. If consent is not given, participant
 contact information will be immediately removed from the system. After consent is obtained,
 participants will complete baseline questionnaires, either by paper surveys or using
 Lifespan's secure REDCap website, and they will complete self-reported logs of what they eat
 and drink and EMA for 1 week before their baseline assessment. If a participant elects to use
 a paper questionnaire and does not wish to be present at the research center, the
 questionnaire will be sent to the participant's home address. Participants must complete >70%
 of EMA surveys and 7 days of dietary self-monitoring to move forward with the remainder of
 study procedures.

 Following consent and successful completion of baseline procedures, participants will attend
 a "kick-off" session (either in-person or remotely) to assist them in using the intervention
 tools. Participants will be given access to an online BOT (described further in the
 Intervention section) for 3 months, with an additional 3-month no treatment follow-up. They
 will also be asked to use the JITAI for the entire 6-month study period. The JITAI operates
 through PiLR Health, and will utilize ecological momentary assessment (EMA) to repeatedly
 assess lapse triggers and dietary lapses. The EMA survey responses are immediately uploaded
 to a HIPAA-compliant server, where a previously-validated predictive algorithm determines if
 the participant may be at risk for a lapse based on what they reported. When a participant is
 determined to be at risk for a lapse after completing an EMA survey, the PiLR Health system
 server will micro-randomize the delivery of intervention. The randomization is independent of
 prior randomizations and the participants' responses to previously delivered interventions
 for lapse. Based on the investigator's prior research developing this JITAI, the algorithm
 predicts heightened states of lapse risk approximately once per day. The once/day estimate is
 representative of an average across participants and the investigators have demonstrated
 there is substantial individual variability to these data; heightened states of lapse risk
 can range from 2.75/week to 12/week and fluctuate over time. As such, while the estimated
 average is once per day, the prediction algorithm within the proposed JITAI ensures that
 intervention is provided in exact moments of individual need - which is not static within or
 between individuals - thus reducing participant burden and improving potency of intervention.
 The study methods are therefore a considerable improvement to providing general daily
 reminders. Based on these data, intervention options will be randomized an average of 180
 times for each participant. The theory-driven intervention conditions, which have empirical
 support, include: (a) education to promote awareness of lapse triggers; (b) self-efficacy;
 (c) motivation; & (d) self-regulation skills. Given the primary aim of comparing the
 immediate, proximal effect of intervention (as compared to no intervention), interventions
 will be randomized based on the following probabilities: 0.4 no intervention (inactive
 control), 0.12 to generic risk alerts (active control), 0.12 to Enhanced Education, 0.12 to
 Self-efficacy, 0.12 to Autonomous Motivation, and 0.12 to Self-regulation. As such, a given
 participant will receive no intervention at approximately 72 randomization points over the
 study and 107 (~21-22 each) randomization points will be divided equally among the remaining
 5 intervention options. All JITAI interventions are described in the Intervention section

 In addition to data they are providing through the JITAI, participants will complete 3 total
 assessments with a research assistant (who does not need to be blinded due to sequential
 randomization) at baseline, 3, and 6 months. During the baseline assessment, height, weight,
 demographic information and weight history will be collected either by a study staff,
 cellular scale, or self-report. Objective data collection will be the priority, so if a
 participant elects to attend their assessment via Zoom, cellular scales may be mailed to the
 participant's home address. Participants will be asked to wear a wrist-watch device (called
 an Actigraph) to measure eating behavior for two weeks following the baseline appointment.
 The participant will be given the Actigraph device in-person during the baseline assessment,
 or by mail to their home address if they choose to attend the assessment via Zoom (the device
 will be mailed back to the study team or dropped off in-person). Also, during the baseline
 assessment, participants will be provided with a calorie and physical activity goal, overview
 of the program, and tutorial for using the smartphone app and online program. The
 participants will be asked to complete similar assessments at 3 months and 6 months.
Inclusion Criteria:

 -  Age 18-70

 -  Body mass index (BMI) between 25 and 50 kg/m-squared

 -  Diagnosis of one or more cardiovascular disease risk factors (prediabetes, type 2
 diabetes, hypercholesterolemia, or hypertension)

 -  Able to walk 2 city blocks without stopping

 Exclusion Criteria:

 -  Currently participating in another weight loss program

 -  Currently taking weight loss medication

 -  Lost > 5% of their body weight in the 6 months prior to enrolling

 -  Has been pregnant within the 6 months prior to enrolling

 -  Plans to become pregnant within 6 months of enrolling

 -  Has chest pain during periods of activity or rest, or loss of consciousness in the 12
 months prior to enrolling

 -  Has any medical condition that would affect the safety of participating in
 unsupervised physical activity

 -  Has history of bariatric surgery

 -  Has any condition that would result in inability to follow the study protocol,
 including terminal illness, substance abuse, eating disorder (not including Binge
 Eating Disorder) and untreated major psychiatric illness.