Trial Outcomes & Findings for Message Framing for Telephone Quitline Callers (NCT NCT00589277)

NCT ID: NCT00589277

Last Updated: 2021-08-26

Results Overview

Percentage of those that self reported attempting to quit smoking at the 2 week follow up.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 2032 participants
• Primary outcome timeframe: 2 week follow up
• Results posted on: 2021-08-26

Participant Flow

Participant milestones

Measure	Standard Care Counseling + Standard Care Print Information Standard care counseling + standard care print information	Gain-Framed Counseling Callers were randomly assigned to receive gain-framed counseling messages and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
Overall Study STARTED	1222	810
Overall Study Completed 2 Week Follow Up	603	424
Overall Study Completed 3 Month Follow Up	762	524
Overall Study COMPLETED	762	524
Overall Study NOT COMPLETED	460	286

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Message Framing for Telephone Quitline Callers

Baseline characteristics by cohort

Measure	Standard Care Counseling n=1222 Participants Standard care counseling + standard care print information	Gain-Framed Counseling n=810 Participants Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.	Total n=2032 Participants Total of all reporting groups
Age, Continuous	46.4 years STANDARD_DEVIATION 13.9 • n=5 Participants	47.2 years STANDARD_DEVIATION 13.4 • n=7 Participants	46.5 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	675 Participants n=5 Participants	478 Participants n=7 Participants	1153 Participants n=5 Participants
Sex: Female, Male Male	547 Participants n=5 Participants	332 Participants n=7 Participants	879 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 week follow up

Population: Per protocol

Percentage of those that self reported attempting to quit smoking at the 2 week follow up.

Outcome measures

Measure	Standard Care Counseling n=603 Participants Standard care counseling + standard care print information	Gain-Framed Counseling n=424 Participants Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
Quit Attempt	101 participants	132 participants

SECONDARY outcome

Timeframe: 2 week follow up

Population: Per protocol

The number of survey respondents that had abstained from smoking at the 2 week follow up.

Outcome measures

Measure	Standard Care Counseling n=603 Participants Standard care counseling + standard care print information	Gain-Framed Counseling n=424 Participants Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
24 Hour Abstinence	76 participants	99 participants

SECONDARY outcome

Timeframe: 3 month follow up

Population: Per protocol

The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up.

Outcome measures

Measure	Standard Care Counseling n=762 Participants Standard care counseling + standard care print information	Gain-Framed Counseling n=524 Participants Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
7 Day Abstinence	202 participants	148 participants

Adverse Events

Standard Care Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gain-Framed Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benjamin Toll, Ph.D. Associate Professor of Psychiatry

Yale University School of Medicine

Phone: (203) 974 5767

Email: benjamin.toll@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place