The "Quit-for-Kids" Project: to Increase Abstinence and Protect Children From Tobacco Smoke Exposure

Официальное название

An Integrated Smoking Cessation Intervention Model of Brief Advice, Nicotine Replacement Therapy and Mobile Health Support for Smoking Parents to Increase Abstinence and Protect Children From Tobacco Smoke Exposure: A Randomized Controlled Trial

Обзор

This project aims to test the effectiveness of an integrated intervention of brief cessation advice (AWARD), Nicotine Replacement Therapy, and Instant Messaging support compared with waitlist control participants among adult daily smokers who lived with their children and non-smoking partners.

Подробное описание

Background: Around 40% of children worldwide were exposed to secondhand smoke (SHS). Despite reaching a single-digit smoking prevalence of 9.5% in 2022, about one in three children in Hong Kong (36.2%) are still exposed to SHS, mostly at home. Especially children from deprived households, suffer from a higher risk of more pervasive SHS exposure. Aim: The project aims to apply evidence-based interventions to increase smoking cessation and reduce SHS exposure in children of disadvantaged families. The specific objectives of the study are (1) to evaluate the effectiveness of a novel, family-based intervention model in increasing smoking cessation and reducing SHS exposure in children of disadvantaged families, (2) to alert parents in recognizing their child's exposure level and take actions in protecting their child from exposure, (3) to advocate for the adoption of this resource-efficient intervention model in Non-Governmental Organizations(NGOs), District Health Centre Express(DHC/Es), and other smoking cessation service providers in Hong Kong.

Methods: A family-based smoking cessation that collect comprehensive biochemical and environmental data of SHS exposure, and apply evidence-based interventions to prevent the SHS exposure and support quitting in deprived households. Two domains of outcome will be assessed: (1) Effectiveness and overall impact of smoking cessation intervention. (2) Cost-effectiveness analysis and qualitative interviews to estimate the scalability and mechanisms of interventions.

Procedure: Participants will be actively recruited through different channels including direct referral from Non-Governmental Organizations (NGOs) with social housing schemes, referral and recruitment from District Health Centre (DHC), community-based recruitment activities in smoking hotspots, and online advertisement on search engines and social media sites. The eligibility of smokers and non-smokers will be assessed by counselors and invited to join the randomized controlled trial and allocated to one of the groups of the smoking cessation intervention. 6 follow ups at 1 week, 1,2,3,6,12 months will be conducted to both smokers and non-smokers to reveal their SHS exposure level and smoker's quitting progress.

Hypothesis: We hypothesize that the assessment-guided intervention will lead to significant increases in rates of smoking cessation in the intervention group than the control group. Another hypothesis to be investigated is that designated intervention messages are effective to reduce the level of SHS participants and their family members exposed to.

Вмешательства

• Поведенческое Brief cessation advice (AWARD)
  Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refuse to set a quit date).
• Препарат Nicotine Replacement Therapy (NRT)
  1-week sampling of Nicotine Replacement Therapy (NRT) will be provided to support quit attempt. Full pharmacological treatment (12-week) will be available if needed.
• Поведенческое Instant messaging Support (IM)
  Chat-based mHealth personalized psychosocial and behavioural counselling (smoking cessation and SHS exposure reduction messages will be derived from previously tested interventional studies) using baseline children health and biofeedback data to support quitting throughout the intervention period of 3 months.
• Поведенческое Financial Incentive (FI)
  A financial incentive (vouchers) of HK$ 500 will be provided for biochemically validated smoking abstinence at 3- and 6-month follow-up. Considering a possibly low engagement rate of the smokers in mHealth-based support (17% in our previous trial, non-engagement mostly due to busy work), additional HK$ 200 will be provided for participants who actively engaged in the mHealth counselling (defined by have discussed quitting process for \>2 times) at 3-month follow-up.
• Поведенческое Self-help smoking cessation booklet
  A well-designed self-help booklet will be provided to guide and provide detailed information on smoking cessation. The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.
• Поведенческое Environmental assessment derived intervention
  In a selected subgroup of 50 families with an additional signed consents, four home visits will be done to: 1. Setup an indoor air quality (IAQ) monitor to collect 24hr air quality data (2 weeks), 2. Collect the monitor for data retrieval, 3. Setup the monitor at 6 months follow-up (2 weeks), 4. Collect the monitor for data retrieval. Environmental assessment derived intervention, including results interpretation and health advice, will be provided via phone calls for the 50 families within 1 w

Первичные конечные точки

• Biochemically validated abstinence [Срок оценки: 6-month after recruitment]

Вторичные конечные точки (12)

• Self-reported 7-day point prevalence quit rate (for smokers) [Срок оценки: 3- and 6-month after recruitment]
• Self-reported reduction rate (for smokers) [Срок оценки: 3- and 6-month after recruitment]
• Self-reported intention to quit (for smokers) [Срок оценки: 3- and 6-month after recruitment]
• Smoking cessation service use (for smokers) [Срок оценки: 3- and 6-month after recruitment]
• Self-rated health (for smokers) [Срок оценки: 3- and 6-month after recruitment]
• Children's secondhand smoke exposure (for children) [Срок оценки: 3- and 6-month after recruitment]
• Academic performance (for children) [Срок оценки: 3- and 6-month after recruitment]
• Cognitive function (for children) [Срок оценки: 3- and 6-month after recruitment]
• Self-reported secondhand smoke exposure (for children and family member) [Срок оценки: 3- and 6-month after recruitment]
• Quality of life (for smokers and family member) [Срок оценки: 3- and 6-month after recruitment]
• Depression and anxiety (for smokers, family member and children) [Срок оценки: 3- and 6-month after recruitment]
• Family well-being (for smokers, family member and children) [Срок оценки: 3- and 6-month after recruitment]

Критерии участия

Критерии включения

• Hong Kong residents aged 18 or above
• Smoke at least 1 tobacco stick (includes HTP) per day or use e-cigarette daily in the preceding 3-month and verified by exhaled carbon monoxide level of 4ppm (parts per million) or above, assessed by a validated Carbon monoxide Smokerlyzer®
• Living with at least one child of primary 6 or below (aged 12 or below)
• Living with at least one non-smoking family member
• Living in deprived households (monthly household income of less than the median of household monthly income in Hong Kong, HK$ 28,000, or living in subdivided flats or social housing)
• Able to communicate in Chinese (including reading Chinese in IM)
• Able to use the instant messaging tool (e.g., WhatsApp, WeChat) for communication

Критерии исключения

• Those who have communication barriers (either physically or cognitively)
• Those who are currently participating in other smoking cessation programmes or services

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• The University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT06127589 · QFK

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗