Just-in-Time Support for Smoking, Vaping, and Eating Urges During High-Stress Moments Among Gender and Sexual Minority Adults in Dhaka

NCT07746492 | Not Yet Recruiting

• 2 other identifiers: PR-26-069GR-02602
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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. This 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. The 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. As 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.

Conditions

Tobacco Use; Electronic Cigarette Use; Emotional Eating; Stress, Psychological

Keywords

micro-randomized trial; just-in-time adaptive intervention; ecological momentary assessment; mHealth; digital health; minority stress; smoking; vaping; stress-attributed eating; urge; Bangladesh; gender and sexual minority; pilot optimization trial

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Smoking or vaping episode following randomization

  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.

• Stress-attributed eating episode following randomization

  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.

• Momentary assessment completion rate

  Across the 24-day assessment period.

• Participant retention through day 24

  Across the 24-day assessment period.

Other Outcomes (1)

• Target-behavior urge intensity at the 10-minute micro-check

  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.

Study Arms (1)

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. Support 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. No 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. The 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.

Behavioral: Just-in-Time Adaptive Support Message

Interventions

Just-in-Time Adaptive Support Message BEHAVIORAL

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.

Micro-randomized JITAI cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is based on the participant's self-identified gender identity and sexual orientation rather than on sex assigned at birth. The study is open to people of any sex assigned at birth who self-identify as a gender or sexual minority person, including but not limited to men who have sex with men, hijra, transgender women, kothi, and gay and bisexual people. Identity terms are affirmed as defined by participants themselves.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Self-identifies as a gender and/or sexual minority person
• Resides in Dhaka at enrolment and expects to remain in Dhaka throughout the 24-day assessment period
• 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
• 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
• Able to read, understand, and respond to simple Bangla text
• Able to operate the study app independently after a structured onboarding session
• Willing to complete five scheduled app-based momentary assessments per day for 24 days and additional brief follow-up assessments after randomized decision points
• Provides written informed consent

You may not qualify if:

• Currently participating in another behavioural or pharmacological intervention study targeting smoking, vaping, or eating behaviour
• 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
• Is unable to operate the study app independently after structured onboarding

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Global Affairs Canada: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, Bangladesh

Location

Related Publications (10)

• Jhe GB, Mereish EH, Gordon AR, Woulfe JM, Katz-Wise SL. Associations between anti-bisexual minority stress and body esteem and emotional eating among bi+ individuals: The protective role of individual- and community-level factors. Eat Behav. 2021 Dec;43:101575. doi: 10.1016/j.eatbeh.2021.101575. Epub 2021 Oct 14.

  PMID: 34757266 BACKGROUND

• Santoniccolo F, Rolle L. The role of minority stress in disordered eating: a systematic review of the literature. Eat Weight Disord. 2024 Jun 8;29(1):41. doi: 10.1007/s40519-024-01671-7.

  PMID: 38850334 BACKGROUND

• Li M, Chau K, Calabresi K, Wang Y, Wang J, Fritz J, Tseng TS. The Effect of Minority Stress Processes on Smoking for Lesbian, Gay, Bisexual, Transgender, and Queer Individuals: A Systematic Review. LGBT Health. 2024 Nov-Dec;11(8):583-605. doi: 10.1089/lgbt.2022.0323. Epub 2024 Apr 1.

  PMID: 38557209 BACKGROUND

• Meyer IH. Prejudice, social stress, and mental health in lesbian, gay, and bisexual populations: conceptual issues and research evidence. Psychol Bull. 2003 Sep;129(5):674-697. doi: 10.1037/0033-2909.129.5.674.

  PMID: 12956539 BACKGROUND

• Goldstein SP, Zhang F, Klasnja P, Hoover A, Wing RR, Thomas JG. Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial. JMIR Res Protoc. 2021 Dec 6;10(12):e33568. doi: 10.2196/33568.

  PMID: 34874892 BACKGROUND

• Battalio SL, Conroy DE, Dempsey W, Liao P, Menictas M, Murphy S, Nahum-Shani I, Qian T, Kumar S, Spring B. Sense2Stop: A micro-randomized trial using wearable sensors to optimize a just-in-time-adaptive stress management intervention for smoking relapse prevention. Contemp Clin Trials. 2021 Oct;109:106534. doi: 10.1016/j.cct.2021.106534. Epub 2021 Aug 8.

  PMID: 34375749 BACKGROUND

• Liu X, Deliu N, Chakraborty B. Microrandomized Trials: Developing Just-in-Time Adaptive Interventions for Better Public Health. Am J Public Health. 2023 Jan;113(1):60-69. doi: 10.2105/AJPH.2022.307150. Epub 2022 Nov 22.

  PMID: 36413704 BACKGROUND

• Cohn ER, Qian T, Murphy SA. Sample size considerations for micro-randomized trials with binary proximal outcomes. Stat Med. 2023 Jul 20;42(16):2777-2796. doi: 10.1002/sim.9748. Epub 2023 Apr 24.

  PMID: 37094566 BACKGROUND

• Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.

  PMID: 26651463 BACKGROUND

• Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.

  PMID: 27663578 BACKGROUND

MeSH Terms

Conditions

Tobacco Use; Vaping; Emotional Eating; Stress, Psychological; Smoking; Coitus

Condition Hierarchy (Ancestors)

Behavior; Feeding Behavior; Behavioral Symptoms; Sexual Behavior

Study Officials

• Pritom K. Das

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pritom K. Das

CONTACT

+8802222277144; pritom.das@icddrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. A 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. At 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.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): February 6, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)