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Active, Not Recruiting

NCT Number: NCT05641974

Effect of Helpers Program On-line Training on Smoking Relapse and Social Networks

The purpose of this study is to assess the effect of the Helpers Stay Quit training on abstinence over time of newly abstinent smokers, and on the interactions they have with their personal network related to smoking and smoking cessation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

About this study

Despite major gains in smoking cessation treatment, over half of recently quit smokers will relapse within the first year. To date, relapse prevention interventions have focused on the newly abstinent smoker ("abstainer"), and not attempted to directly or indirectly influence the abstainer's personal network, e.g. by helping the abstainer influence others in their personal network to quit. Personal networks exert powerful effects on initiating and maintaining smoking behavior, and can facilitate maintaining abstinence or trigger relapse. A "help others" intervention that seeks to increase the abstainer's ability to influence smokers in their personal network to quit - thereby creating a social environment more supportive of long-term abstinence - may have a beneficial effect on relapse. The Helpers Stay Quit intervention encourages abstainers to reinforce their own abstinence through helping others quit, and to proactively influence their personal network to be more conducive to long-term smoking abstinence. Helpers Stay Quit teaches abstainers how to encourage other tobacco users to quit and avoid relapse through a non-confrontational "helping conversation" that encourages quitting and use of evidence-based cessation aids (e.g. Quitlines, cessation medications) without confrontation and nagging. The investigator hypothesizes that Quitline abstainers exposed to Helpers Stay Quit will have higher 30-day and 7-day point prevalence abstinence than those receiving Quitline follow-up usual care, and that the effect of Helpers Stay Quit may be mediated by personal network characteristics. To test this hypothesis, the investigator proposes a pragmatic randomized controlled trial with embedded mixed-methods personal network study to assess the effect of Helpers Stay Quit training on proportion and duration of abstainers' abstinence over time, and on abstainer's personal network interactions related to smoking and smoking cessation. Metrics derived from the personal network study will be used for mediational analyses of overall, and gender-based effects of Helpers Stay Quit on smoking relapse.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Abstinent from smoking for between 14 and 60 days
  • Primary tobacco use is cigarettes
  • Has access to Internet via computer or mobile device
  • Self-described proficiency with English
  • Willing and able to send/receive weekly text messages using personal mobile phone plan
  • Will allow Quitline to share their client data with research team
  • Willing to complete online surveys at baseline, 3-, 6-, 9- and 12 months
  • Willing to self-collect dried blood spot and send back to research team
  • If assigned to Helpers Stay Quit condition, willing to complete training within 14 days
  • If selected, willing to participate in qualitative interview
  • Willing to forego any other training for tobacco cessation intervention/support (i.e., to become a cessation counselor/facilitator or support person, e.g., 'quit buddy') for the duration of their study enrollment

Exclusion criteria

  • Any prior exposure to Helpers training or other cessation training in the previous 2 years

Treatment and study plan

Helpers Stay Quit Training

Behavioral

The Helpers Stay Quit training emphasizes a tobacco-user centered, non-confrontational approach to encouraging others to quit smoking. Helpers Stay Quit trainees learn how to offer a 4-step "helping conversation". The four steps of a helping conversation parallel the 4 core training modules of Helpers Stay Quit (Awareness, Understanding, Helping, Relating). A key learning objective of Helpers Stay Quit, is for Helpers to learn how to manage their own expectations for the process and outcome of a helping conversation (e.g. Helpers are taught that they cannot "make" anyone quit, but they can offer non-judgmental support, and information about effective cessation aids). Consequently, Helpers are taught to manage their own behavior when helping others (e.g. avoiding nagging or pushing a tobacco-user to quit). The helping conversation focuses on encouraging behavior change that is aligned with the tobacco user's current willingness/readiness to take any action toward quitting.

Primary outcomes

  1. 7-day and 30-day abstinence from using combustible tobacco at 6 months post-randomization

    Time frame: Self-reported data collected at 6 months post-randomization

    Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.

  2. 7-day and 30-day abstinence from using combustible tobacco at 12 months post-randomization

    Time frame: Self-reported data collected at 12 months post-randomization

    Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.

Secondary outcomes

  1. 7-day and 30-day abstinence from using combustible tobacco at 3 months and 9 months post-randomization

    Time frame: Self-reported data collected at 3- and 9-months post-randomization

    Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.

  2. Time to first relapse

    Time frame: Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization

    Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.

  3. Number, timing, and duration of relapses

    Time frame: Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization

    Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.

  4. Number of helping conversations offered

    Time frame: Weekly data collected months 1-6; bi-weekly data collected months 7-12; data collected at 3-, 6-, 9-, and 12-months post-randomization

    Participants report the number of helping conversations (if any) offered within the specified timeframe.

  5. Biochemical confirmation of abstinence at 6 and 12 months on a subsample

    Time frame: Data collected and 6- and 12-months post-randomization

    Participants who report abstinence at 6- and 12-months (and no other exposure to nicotine) receive a dried blood spot kit which is returned and tested for cotinine.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 8, 2022
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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