Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784585
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2021-02-25
Brief Title:
Miro-randomized Trial for Optimizing a JITAI to Reduce Dietary Lapses in Obesity Treatment
Sponsor:
The Miriam Hospital
Organization:
The Miriam Hospital
Study Overview
Official Title:
Optimizing Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment A Micro-randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 eg 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 ie reported by the participant in the daily surveys and objectively ie via wrist-based intake monitoring in the hours following randomization initiated by heightened lapse risk
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 ie reported by the participant in the daily surveys and objectively ie via wrist-based intake monitoring in the hours following randomization initiated by heightened lapse risk
Detailed Description:
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 pilotingtesting only and will not be used in the analysis of primary outcomes Participants in the main trial N159 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 ie location time of day active BOTfollow-up trigger type for the studys exploratory aim JITAI engagement satisfaction and weight will be used for descriptive purposes
Participants will be recruited on a rolling basis 6-7 participantsmonth until the target N159 is reached Participants will be recruited via advertisements in local media eg newspapers radio and targeted online advertising eg 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 Lifespans 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 participants 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 investigators prior research developing this JITAI the algorithm predicts heightened states of lapse risk approximately once per day The onceday 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 275week to 12week 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 04 no intervention inactive control 012 to generic risk alerts active control 012 to Enhanced Education 012 to Self-efficacy 012 to Autonomous Motivation and 012 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 participants 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
Participants will be recruited on a rolling basis 6-7 participantsmonth until the target N159 is reached Participants will be recruited via advertisements in local media eg newspapers radio and targeted online advertising eg 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 Lifespans 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 participants 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 investigators prior research developing this JITAI the algorithm predicts heightened states of lapse risk approximately once per day The onceday 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 275week to 12week 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 04 no intervention inactive control 012 to generic risk alerts active control 012 to Enhanced Education 012 to Self-efficacy 012 to Autonomous Motivation and 012 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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL153543 | NIH | None | httpsreporternihgovquickSearchR01HL153543 |