A Video-led Smoking Cessation Intervention in Helping Male Smokers Whose Partners Got Pregnant to Quit Smoking

NCT03236025 | Completed DMC

• 1 other identifier: UW17-269
• Study Type: interventional
• Target: 1,023
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to use a three arms randomized clinical trial study to evaluate the effectiveness of a video-led intervention in helping male smokers whose partner got pregnant in Mainland China to quit smoking.

Conditions

Smoking Cessation

Keywords

smoking cessation; video; male smoker

Outcome Measures

Primary Outcomes (1)

• Biochemically validated smoking abstinence at the 6-month follow-up

  The biochemically validated smoking abstinence was confirmed by an exhaled carbon monoxide level \< 4 parts per million (p.p.m.)

  6-month follow-up

Secondary Outcomes (2)

• Self-reported 7-day point prevalence quit rate

  6-month follow-up

• The level of readiness to quit

  6-month follow-up

Study Arms (3)

Experimental group

EXPERIMENTAL

Video+one-sentence smoking cessation advice +general smoking cessation leaflet will be allocated to the participants in the experimental group. The videos which presented the health effects of smoking, especially emphasizing the importance of smoking cessation on the fetal and pregnancy, will be sent in sequence through the smart phone to the participants in the experimental group.

Combination Product: Video+brief smoking cessation+pamphlet

Conditional control group

ACTIVE COMPARATOR

Text-message+one-sentence smoking cessation advice +general smoking cessation leaflet will be allocated to the participants in the experimental group. Text-message contains the same content with videos and will be sent in the same frequency with the videos through the smart phone to the participants in the Conditional control group.

Combination Product: Text-message+brief smoking cessation+pamphlet

Placebo control group

PLACEBO COMPARATOR

Participants in the control group will be given a one-sentence smoking cessation advice during the baseline assessment. A leaflet showed the information related to the smoking cessation will be allocated to them at the same time.

Other: brief smoking cessation+pamphlet

Interventions

Video+brief smoking cessation+pamphlet COMBINATION_PRODUCT

The videos presented the health effects of smoking, especially emphasizing the importance of smoking cessation on pregnant women, fetuses, and newborns.

Experimental group

Text-message+brief smoking cessation+pamphlet COMBINATION_PRODUCT

The text -message contains the same content with the videos

Conditional control group

brief smoking cessation+pamphlet OTHER

The pamphlet showed the general information related to the smoking cessation, the brief smoking cessation only contains a sentence like "You'd better quit smoking."

Placebo control group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male resident aged 18 or above;
• smoking at least one cigarette per day averagely during the past 1 months and validated by exhaled CO test (≥ 4ppm);
• have a pregnant partner whose embryo had been confirmed to not have any significant deformity;
• able to communicate in Mandarin (including reading Chinese);
• have a smart phone for intervention and follow-up

You may not qualify if:

• smokers who meet the above criteria but are currently involved in other smoking cessation programs or the pilot study;
• mentally or physically unfit for communication;

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• Xia W, Li HCW, Cai W, Song P, Zhou X, Lam KWK, Ho LLK, Cheung AT, Luo Y, Zeng C, Ho KY. Effectiveness of a video-based smoking cessation intervention focusing on maternal and child health in promoting quitting among expectant fathers in China: A randomized controlled trial. PLoS Med. 2020 Sep 29;17(9):e1003355. doi: 10.1371/journal.pmed.1003355. eCollection 2020 Sep.

  PMID: 32991589 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• William Ho Cheung LI, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: 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 27, 2017
• First Posted: August 1, 2017
• Study Start: July 1, 2017
• Primary Completion: October 31, 2018
• Study Completion: March 31, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)