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

Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Study ID
NCT07746492
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Aug 5, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Jan 30, 2027
Completion
Feb 6, 2027

Study Design

Enrollment
115 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Micro-randomized JITAI cohort
    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.

Primary Outcome Measure

Target-behavior momentary urge intensity [ Time Frame: 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. ]

Central Contacts

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