A Joint Real-World Study of Digital Smoking Cessation Interventions

NCT05996029 | Unknown

• 1 other identifier: K4011
• Study Type: interventional
• Target: 2,214
• Locations: 1 country
• Sites: 1

Brief Summary

According to the "China Smoking Health Hazard Report 2020", the total number of smokers in China is estimated to be 350 million, of which 180 million are already addicted. In addition, more than 700 million nonsmokers are exposed to secondhand smoke and become passive smoking victims, among which the family is one of the main places of secondhand smoke exposure, and mothers and children are the most affected group. Passive smoking is a risk factor for spontaneous abortion in pregnant women and an important risk factor for the occurrence of gestational hypertension syndrome and pregnancy complications, and it also affects embryonic development with adverse pregnancy outcomes such as miscarriage, stillbirth, intrauterine growth retardation, preterm birth, immune deficiency, birth defects, and mental retardation. Helping smokers quit is the fundamental solution to reducing secondhand smoke exposure. The accessibility and effectiveness of traditional offline smoking cessation intervention services do not meet the needs of society. With the development of mobile communication technology, digital cessation such as SMS cessation, WeChat cessation, and APP cessation have emerged, which combine clinical cessation guidelines with software technology and present rich product features and interactive design, providing a new solution to expand the accessibility of clinical cessation interventions and address the problem of secondhand smoke exposure.We hope to explore the impact of different digital cessation tools and their combinations on reducing smoking prevalence and maternal tobacco exposure.

Conditions

Tobacco Smoke Pollution; Passive Smoking; Secondhand Smoking

Outcome Measures

Primary Outcomes (2)

• Biologically validated subject withdrawal rate

  Urine cotinine concentrations was determined using a cotinine test kit (colloidal gold) at the end of follow-up.

  through study completion, an average of 4 months

• Biologically validated maternal environmental tobacco exposure rate

  Urine cotinine concentration was determined using a cotinine test kit (colloidal gold method) at the end of enrollment and follow-up to determine the exposure of second-hand smoke.

  through study completion, an average of 4 months

Secondary Outcomes (3)

• Engagement and adherence to digital smoking cessation interventions

  through study completion, an average of 4 months

• Self-reported abstinence rates for subjects at weeks 1, 2, 3, 4, 8, and 12 after quitting date

  through study completion, an average of 4 months

• Changes in maternal and smoking cessation subjects' respective psychological scale assessments at baseline and at the end of follow-up

  through study completion, an average of 4 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Intensive intervention package "Quit with Love" (1 month) 1. Cognitive-behavioral (CBT) smoking cessation intervention 2. ACT cessation intervention with positive thinking 3. Online group smoking cessation intervention through live streaming "Quit Assistant" intelligent support platform (3 months) 1. Quit smoking punch card toolkit 2. Machine learning algorithm-driven cessation assistance practice service

Combination Product: Digital Smoking Cessation

control group

NO INTERVENTION

Reduced functionality of the Love Quit applet Only a simple smoking punch card support function, mainly used to assist subjects to quit smoking on their own and collect follow-up information

Interventions

Digital Smoking Cessation COMBINATION_PRODUCT

The core technology of the study is a smoking cessation assistance practice service driven by a machine learning algorithm. The small programs used by the intervention group in this study included smoking cessation service packages based on cognitive behavioral therapy and online guidance from medical staff on staff, and more digital smoking cessation tools.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Sir Run Run Shaw Hospital: collaborator
• Hangzhou Medisol Technology Co.: collaborator

Study Sites (1)

Department of ob gyn, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 16, 2023
• Study Start: August 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)