[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650370":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":41,"studyPopulation":38,"armGroups":42,"interventions":49,"overallOfficials":55,"centralContacts":59,"locations":64,"responsibleParty":78,"collaborators":80,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":38,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":38,"enrollmentInfo":92,"targetDuration":38,"studyType":95,"phases":96,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":116,"whyStopped":38,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"International Centre for Diarrhoeal Disease Research, Bangladesh","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Target-behavior momentary urge intensity","Self-reported current urge intensity for the participant's locked target behavior, rated on an 11-point numeric rating scale from 0 to 10. For participants targeting smoking or vaping, the outcome is the urge to smoke or vape. For participants targeting stress-attributed eating, the outcome is the urge to eat in response to stress or emotional distress. Only the rating corresponding to the participant's locked target behavior contributes to the primary outcome. Scores are not combined into a within-assessment composite. A score of 0 indicates no urge at all and 10 indicates the strongest urge imaginable; higher scores indicate a worse outcome.","At the primary follow-up delivered 45 minutes after each randomized decision point, with responses accepted through 60 minutes after randomization; assessed repeatedly throughout the 24-day assessment period.",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"Smoking or vaping episode following randomization","Among participants whose locked target behavior is smoking or vaping, binary self-report of whether any smoking or vaping occurred between the randomized decision point and the follow-up assessment. Coded 0 for no and 1 for yes; a higher occurrence rate indicates a worse outcome.","From each randomized decision point through the primary follow-up delivered 45 minutes later, with responses accepted through 60 minutes after randomization; assessed repeatedly throughout the 24-day assessment period.",{"measure":19,"description":20,"timeFrame":17},"Stress-attributed eating episode following randomization","Among participants whose locked target behavior is stress-attributed eating, binary self-report of whether the participant ate primarily because of stress or emotional discomfort between the randomized decision point and the follow-up assessment. Eating primarily because of hunger, social context, food availability, or another non-emotional reason is not counted. Coded 0 for no and 1 for yes; a higher occurrence rate indicates a worse outcome.",{"measure":22,"description":23,"timeFrame":24},"Momentary assessment completion rate","Percentage of momentary assessments completed within the allowed response window, calculated overall and per participant. The denominator will include assessments delivered and available for completion and will exclude assessments automatically suppressed by the protocol because they fell within 60 minutes after a randomization. Pre-specified progression thresholds: 70 per cent or above proceed; 50 to 69 per cent proceed with protocol amendment; below 50 per cent do not proceed to a future trial without redesign.","Across the 24-day assessment period.",{"measure":26,"description":27,"timeFrame":24},"Participant retention through day 24","Percentage of enrolled participants who complete the full 24-day assessment period, and the mean number of days contributed per participant. Pre-specified progression threshold: attrition of 15 per cent or less proceed; 16 to 30 per cent proceed with amendment; above 30 per cent redesign before a future trial.",[29],{"measure":30,"description":31,"timeFrame":32},"Target-behavior urge intensity at the 10-minute micro-check","Exploratory self-reported current urge intensity for the participant's locked target behavior, rated from 0 to 10 using the same behavior-specific item and anchors as the primary outcome. Higher scores indicate a stronger urge and a worse outcome. This measure will be used to estimate the early proximal effect of the support message and will not be treated as a primary endpoint.","At the micro-check delivered 10 minutes after each randomized decision point, with responses accepted through 15 minutes after randomization; assessed repeatedly throughout the 24-day assessment period.",{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":38,"timePerspective":38,"maskingInfo":39},"NA","SINGLE_GROUP","Micro-Randomized Trial. All participants enter a single 24-day cohort; there are no separate permanent participant groups. Randomization occurs repeatedly within each participant, not once at enrolment, so the unit of randomization is the eligible decision point.\n\nA decision point is eligible when a completed assessment shows stress of 5 or higher (0-10 scale), the participant confirms it is safe and private to receive a message, the target behaviour has not occurred since the prior assessment, and no randomization has occurred in the preceding 90 minutes, within the allowed response window.\n\nAt each eligible decision point the platform independently randomizes, with fixed probability 0.50, to immediate delivery of a brief support prompt or no prompt. These are momentary options available to every participant, not permanent groups; each participant is expected to receive both many times. Approximately 1,225 randomized decision points are expected, split evenly between options.","TREATMENT",null,{"masking":40,"maskingDescription":38,"whoMasked":38},"NONE","Registered Study and Formative Phase: The registered interventional study is a micro-randomized trial (MRT) involving 115 participants over a 24-day assessment period. It is preceded by a formative cultural adaptation and technical refinement phase conducted to develop, optimize, and lock the momentary assessment items, support message library, notification wording, and digital safety features. This preliminary phase comprises cognitive walkthroughs and think-aloud interviews with approximately 10 community members, a short structured momentary assessment run to characterize the naturalistic distribution of momentary stress ratings, and a technology validation period. The formative phase involves no randomization and no assignment to any intervention. It is not part of the registered interventional cohort, is not included in the registered enrollment figure, and does not determine the study start date.\n\nMicro-Randomization Framework: Randomization occurs repeatedly within each participant rather than once between participants. Each participant is randomized at every decision point during the 24-day period that satisfies all predefined eligibility criteria, thereby contributing both intervention and control observations over time. The primary unit of randomization and proximal observation is the eligible decision point; repeated observations are nested within participants.\n\nDecision Point Definition: Randomization occurs at available high-stress decision points, defined as a completed momentary assessment at which all five of the following conditions are satisfied simultaneously: the assessment is completed within the allowed 30-minute response window; the participant reports a current stress level of 5 or higher on a 0 to 10 scale; the participant confirms that it is currently safe and private enough to receive a message; the participant has not already reported performing their designated primary target behavior since the preceding completed assessment; and no randomization has occurred in the preceding 90 minutes. Moments that fail any criterion are logged by the platform for system audit and feasibility monitoring but are not randomized.\n\nRandomization Procedure: At each available decision point, the digital platform randomizes prompt assignment independently, with a fixed probability of p = 0.50, to either delivery of a supportive coping prompt or no prompt (active assessment control). The randomization outcome and timestamp are securely logged.\n\nAssessment Schedule and Conflict Resolution: Participants receive five scheduled baseline momentary assessments per day, delivered at randomized times within five pre-specified daily time blocks, with one assessment per block across the 24-day period. Following every randomization, in both the prompt and no-prompt conditions, participants complete a brief micro-check assessment at 10 minutes, with a 5-minute response window, and a main proximal follow-up assessment at 45 minutes, with a 15-minute response window. To prevent assessment overload and survey collision, if a regularly scheduled baseline assessment falls within 60 minutes after a randomization, that scheduled assessment is automatically suppressed by the platform and recorded as protocol-suppressed rather than missing.\n\nTarget Behaviour and Multi-Behavioral Logic: Participants who qualify on both smoking\u002Fvaping and stress-attributed eating designate a single primary target behavior at baseline. This designation is locked before the assessment period begins and remains fixed throughout the study to maintain primary outcome integrity. Urge intensity for both behaviors is measured at every momentary assessment to allow descriptive, exploratory characterization of urge patterns across behaviors, consistent with the pre-specified exploratory outcome measures; however, only the locked target behavior provides the primary confirmatory outcome. Urge scores for the two behaviors are analyzed independently and are never averaged or combined.\n\nSample Size and Power Assumptions: The target enrolment is 115 participants. Under the planning assumptions regarding attrition, momentary assessment completion, high-stress trigger frequency, and availability, approximately 1,225 randomized decision points are expected. Detailed power assumptions and sensitivity analyses will be prespecified in the statistical analysis plan.\n\nStatistical Analysis Plan: The primary analysis estimates the proximal causal effect of prompt delivery on behaviour-specific urge intensity using weighted and centered least squares with robust standard errors. Binary secondary outcomes are analysed using the estimator for causal excursion effects with binary proximal outcomes. Secondary behavioural outcomes are powered for estimation rather than for confirmatory testing and are reported with confidence intervals to inform the design of a future trial.\n\nInterpretation, Estimands, and Scope: The control condition is \"no message\" within the context of active momentary monitoring, rather than a neutral placebo message. The estimated causal effect therefore reflects the incremental contribution of receiving a supportive coping prompt relative to active self-monitoring alone, and does not separate the effect of the prompt's content from the effect of being notified at all. Participants are not blinded to condition, and outcomes are self-reported. The 10-minute micro-check is delivered identically across both conditions, holding proximal self-monitoring and appraisal constant across arms. These design features are inherent to the JITAI framework and are stated as part of the estimand in all reports of findings.\n\nSafety, Privacy, and Advisory Governance: Privacy is treated as an essential component of participant safety. Notification wording is neutral and non-disclosing, and intervention content is displayed only after the participant opens the study application. Participants may decline, skip, or temporarily pause assessments at any time.\n\nDirect identifiers are stored separately from momentary assessment data, and access is restricted to authorized study personnel. A prespecified distress-response and referral protocol operates throughout the trial.\n\nA Community Advisory Board reviews the recruitment procedures, assessment items, support-message content, notification wording, digital safety protections, and distress-response procedures before the trial materials are finalized and locked.",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"Micro-randomized JITAI cohort","EXPERIMENTAL","All participants enter a single 24-day micro-randomized cohort. At each eligible high-stress decision point, the platform independently randomizes with probability 0.50 between two momentary options.\n\nSupport prompt: The app immediately delivers one brief, culturally adapted coping-support message from a locked library. The message is matched to the participant's prespecified target behavior, can be read in under one minute, and does not disclose identity or community membership.\n\nNo prompt: No immediate coping-support message is delivered. The 10-minute micro-check and 45-minute follow-up are delivered on the same schedule in both options. No existing care is withheld, and participants retain access to study contact and distress-referral information.\n\nThe contrast is immediate support prompt versus no immediate support prompt. Thus, the estimated proximal effect combines receiving the message with its coping content; these components are not estimated separately.",[48],"Behavioral: Just-in-Time Adaptive Support Message",[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":38},"BEHAVIORAL","Just-in-Time Adaptive Support Message","A brief, culturally adapted, in-app behavioral support message delivered on the participant's own smartphone immediately after randomization at an eligible high-stress decision point. Content is finalized and locked before the trial following a formative cultural adaptation phase and review by a Community Advisory Board. The message is matched to the participant's locked target behavior and may include grounding, urge-delay, motivational, values-based, environmental, substitute-action, social-support, or location-change strategies. It is nonjudgmental, action-oriented, designed to be read in under one minute, and requires no immediate response. At decision points randomized to the no-message option, no immediate support message is delivered.",[44],[56],{"name":57,"affiliation":5,"role":58},"Pritom K. Das","PRINCIPAL_INVESTIGATOR",[60],{"name":57,"role":61,"phone":62,"phoneExt":38,"email":63},"CONTACT","+8802222277144","pritom.das@icddrb.org",[65],{"facility":66,"status":38,"city":67,"state":38,"zip":38,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)","Dhaka","Bangladesh","BD",{"type":71,"coordinates":72},"Point",[73,74],90.40744,23.7104,{"lat":74,"lon":73},[77],{"name":57,"role":61,"phone":62,"phoneExt":38,"email":63},{"type":79,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[81],{"name":82,"class":6},"Global Affairs Canada","100650370","just-in-time-support-for-smoking-vaping-and-eating-urges-during-high-stress-moments-among-gender-and-sexual-minority-adults-in-dhaka-100650370",false,"NCT07746492","Just-in-Time Support for Smoking, Vaping, and Eating Urges During High-Stress Moments Among Gender and Sexual Minority Adults in Dhaka","A Digital Real-Time Support for Stress-Induced Smoking and Unhealthy Eating Among Gender and Sexual Minorities in Dhaka","Inclusion Criteria:\n\n* Age 18 years or older\n* Self-identifies as a gender and\u002For sexual minority person\n* Resides in Dhaka at enrolment and expects to remain in Dhaka throughout the 24-day assessment period\n* Reports at least one qualifying behaviour on average at least 3 days per week during the past month: (a) smoking or vaping, or (b) eating primarily in response to stress, anxiety, or emotional distress\n* Owns a personal Android or iOS smartphone compatible with the study platform that is used solely by the participant and is not shared with others\n* Able to read, understand, and respond to simple Bangla text\n* Able to operate the study app independently after a structured onboarding session\n* Willing to complete five scheduled app-based momentary assessments per day for 24 days and additional brief follow-up assessments after randomized decision points\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Currently participating in another behavioural or pharmacological intervention study targeting smoking, vaping, or eating behaviour\n* Has a severe or unstable psychiatric condition that, based on screening and review by the study clinician, would make participation in the repeated daily assessment protocol unsafe\n* Is unable to operate the study app independently after structured onboarding","ALL","18 Years",{"count":93,"type":94},115,"ESTIMATED","INTERVENTIONAL",[34],"Gender and sexual minority adults in Bangladesh experience high levels of stigma-related stress. Acute stress can trigger strong, affect-driven urges to smoke, vape, or engage in stress-attributed eating. These urges can rise and fall within minutes to hours, operating outside the reach of conventional clinic-based interventions delivered days or weeks later.\n\nThis pilot micro-randomized trial (MRT) evaluates whether delivering a brief, culturally adapted support message via smartphone during moments of high self-reported stress reduces the intensity of the urge for the participant's pre-specified target behaviour, relative to no message. Over a 24-day period, 115 participants will be scheduled for up to 5 ecological momentary assessments (EMA) per day. Whenever a participant reports an acute stress level of 5 or higher (0 to 10 scale) and satisfies pre-specified privacy, safety, behavioural, and spacing criteria, the app randomizes with probability 0.5 to deliver either a brief support message or no message. By contributing multiple randomized decision points over time, each participant serves as their own micro-control.\n\nThe primary outcome is the intensity of the urge for the participant's pre-specified target behaviour, measured 45 to 60 minutes after randomization. An exploratory urge assessment is also collected 10 minutes after randomization; comparing the two time points will help establish whether the support message's effect is immediate, delayed, or both, and will inform the choice of follow-up window for a future, fully powered trial. Prior to trial launch, all EMA items, message content, notification logic, and digital safety protocols will be developed and tested with community members, reviewed by a Community Advisory Board, and locked.\n\nAs a pilot optimization trial, its objectives are to estimate the short-term causal effect of the prompt, to identify the contexts in which that effect is larger or smaller, and to establish whether momentary assessment and just-in-time intervention research can be delivered safely, privately, and acceptably in this high-stigma setting. The study does not evaluate long-term behavioural maintenance and does not claim to address the underlying structural stigma and discrimination that produce minority stress.",[99,100,101,102],"Tobacco Use","Electronic Cigarette Use","Emotional Eating","Stress, Psychological",[104,105,106,107,108,109,110,111,112,113,68,114,115],"micro-randomized trial","just-in-time adaptive intervention","ecological momentary assessment","mHealth","digital health","minority stress","smoking","vaping","stress-attributed eating","urge","gender and sexual minority","pilot optimization trial","NOT_YET_RECRUITING","2026-07-30",{"date":119,"type":120},"2026-08-05","ACTUAL",{"date":122,"type":94},"2026-09-01",{"date":124,"type":94},"2027-02-06",{"name":5,"class":6},1]