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Motivating Change in Aging Smokers

Aim-3: Alzheimer's Disease and Related Dementias Prevention Messaging to Increase Smoking Cessation Attempts in Older Adult Smokers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05194917
Enrollment
201
Registered
2022-01-18
Start date
2023-08-15
Completion date
2024-02-29
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

older smoker, motivational intervention

Brief summary

The purpose of this research is to evaluate messages that motivate older smokers to make quit attempts using evidence based smoking treatments (EBSTs). 200 participants will be recruited nationally (within the United States) primarily via social media advertisements. Participation will include up to 2 interviews by telephone and receiving flyers via mail.

Detailed description

Overview. This study will use a pre-post design to assess feasibility and preliminary effectiveness of a developed Older Smoker Motivational Intervention (OSMI) presented in a large primary care clinic. Participants will be randomized to one of four messaging interventions; 1) active control (CDC TIPS from former smokers campaign), 2) active control (American Lung Association campaign), 3) treatment condition including message package focused on the link between smoking and dementia, 4) no intervention control. The messaging intervention will be delivered via mail, which will include a QR code link that will allow participants to view associated motivational video. Participants will then complete the first of 2 telephone survey assessments (lasting \ 30 minutes). Participants will then receive three mailers over the next couple of months and will schedule their follow-up call approximately 2.5 months later. At one to two weeks, one month, and two months after this call they will be mailed the corresponding message to their group (no intervention group will not be sent a message package). Follow up telephone assessments will occur within approximately 1-2 weeks following intervention exposure marked by date the intervention mailer was sent. Participants. Older adults from the community (N=200) who are ages 50-80, self-report being a current smoker, do not hold a current diagnosis of dementia or Mild Cognitive Impairment (MCI), can read and write in English will be eligible to participate, located within the United States. Setting/Recruitment. Participants will be recruited nationally (within the United States) primarily via social media advertisements. Should these efforts fail, the investigators will use flyers and television advertisements. Those interested in participating in the study will call the provided contact information to enroll in the study directly with University of Wisconsin Center for Tobacco Research and Intervention (UW-CTRI) staff. Upon contacting UW-CTRI, the investigators will confirm their location via their provided address. All data collected for this study will be stored an a secure departmental server (electronic data) or in a locked file cabinet in a locked room at UW-CTRI (physical copies of data). Audio files of recordings will be stored on a secure departmental server. Procedure and Assessments. Upon study initiation 200 participants will be recruited for the study and provide informed consent. After consent they will be randomized to one of the 4 study conditions (active control1, active control 2, no intervention, treatment condition). They will then complete the first of 2 telephone survey assessments (lasting \ 25 minutes). Participants will then be informed they will receive three mailers over the next couple of months and will schedule their follow-up call approximately 2.5 months later. At two weeks, one month, and two months after this call they will be mailed the corresponding message to their group (no intervention group will not be sent a message package). Follow up telephone assessments will occur within approximately 1-2 weeks following intervention exposure marked by date the intervention mailer was sent. Up to 20 participants randomized to the intervention condition will complete an additional brief qualitative interview following their second telephone survey assessment (lasting \ 20 minutes). The qualitative interview will focus on the perceived impact of the message, preferred number of message exposures, preferred modality of message receipt, and suggested improvement to message content. Health Believe Model (HBM)1 constructs assessed include: perceived severity, perceived benefits (i.e., efficacy of EBSTs; impact of quitting on Alzheimer's disease and related dementias (ADRD) risk), perceived barriers (i.e., knowledge of how to access EBSTs in healthcare setting), and self-efficacy (i.e., confidence in ability to quit in the next 30 days). Analyses. The investigators will evaluate preliminary effectiveness by descriptively comparing primary (1) and secondary (2) outcomes longitudinally (baseline vs. follow up) within participants, as well as cross-sectionally comparing follow-up data by treatment randomization groups (Intervention Message vs. Control Message; Intervention Message vs. Treatment as Usual (TAU); TAU vs. Control Message). The investigators will assess feasibility during follow-up via receipt and comprehension of messages. The HBM1 outcomes will be compared longitudinally within participant to identify potential mechanisms of action for the interventions and identify potential changes to the interventions prior to a larger randomized controlled trial (RCT). Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) domains preliminarily assessed will include (1) Reach: comprehension of motivational and access message; (2) Efficacy on smoking-cessation related beliefs and intentions (i.e., motivation to quit, quit attempts, and use of EBSTs when quitting); and (3) Implementation of the novel OSMI will be assess via qualitative interviews with participants.

Interventions

OTHEROlder Smoker Motivational Intervention

OSMI identified in Aim 2 of the study, motivational interventions will be delivered via mailer with QR video code.

OTHERControl Motivational Message

One control motivational message with a standard health- and EBST access-related content (i.e., Quitting smoking is the best thing you can do for your health. Call 1-800-QUIT-NOW for help.), motivational interventions will be delivered via mailer with QR video code.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* ages 50-80 * can read and write English * current smoker

Exclusion criteria

* current diagnosis of dementia or mild cognitive impairment

Design outcomes

Primary

MeasureTime frameDescription
Change in Motivation to Quit Within the Next 30 Daysbaseline (during wave 1), up to 6 months (during wave 2)Motivation to Quit within the next 30 days is measured on a 10-point likert scale from 1 (not at all motivated) to 10 (extremely motivated); higher numbers indicate more motivation to quit.

Countries

United States

Participant flow

Participants by arm

ArmCount
Older Smoker Motivational Intervention
Message package focused on the link between smoking and dementia Older Smoker Motivational Intervention: OSMI identified in Aim 2 of the study, motivational interventions will be delivered via mailer with QR video code.
52
Control Motivational Message 1
CDC TIPS from former smokers campaign Control Motivational Message: One control motivational message with a standard health- and EBST access-related content (i.e., Quitting smoking is the best thing you can do for your health. Call 1-800-QUIT-NOW for help.), motivational interventions will be delivered via mailer with QR video code.
50
Control Treatment as Usual
No intervention
49
Control Motivational Message 2
American Lung Association campaign Control Motivational Message: One control motivational message with a standard health- and EBST access-related content (i.e., Quitting smoking is the best thing you can do for your health. Call 1-800-QUIT-NOW for help.), motivational interventions will be delivered via mailer with QR video code.
50
Total201

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up7565

Baseline characteristics

CharacteristicControl Motivational Message 1TotalControl Motivational Message 2Control Treatment as UsualOlder Smoker Motivational Intervention
Age, Continuous61.34 years
STANDARD_DEVIATION 6.33
62.52 years
STANDARD_DEVIATION 7.06
63.26 years
STANDARD_DEVIATION 7.41
62.53 years
STANDARD_DEVIATION 7.12
62.92 years
STANDARD_DEVIATION 7.37
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
8 Participants38 Participants9 Participants10 Participants11 Participants
Race (NIH/OMB)
More than one race
1 Participants7 Participants2 Participants2 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants5 Participants2 Participants0 Participants0 Participants
Race (NIH/OMB)
White
38 Participants150 Participants37 Participants37 Participants38 Participants
Region of Enrollment
United States
50 participants201 participants50 participants49 participants52 participants
Sex/Gender, Customized
Female
30 Participants119 Participants30 Participants28 Participants31 Participants
Sex/Gender, Customized
Male
20 Participants81 Participants20 Participants20 Participants21 Participants
Sex/Gender, Customized
Non-binary
0 Participants1 Participants0 Participants1 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 520 / 500 / 490 / 50
other
Total, other adverse events
0 / 520 / 500 / 490 / 50
serious
Total, serious adverse events
0 / 520 / 500 / 490 / 50

Outcome results

Primary

Change in Motivation to Quit Within the Next 30 Days

Motivation to Quit within the next 30 days is measured on a 10-point likert scale from 1 (not at all motivated) to 10 (extremely motivated); higher numbers indicate more motivation to quit.

Time frame: baseline (during wave 1), up to 6 months (during wave 2)

Population: Several participants were lost to follow-up at 6 Months Post-Intervention.

ArmMeasureGroupValue (MEAN)Dispersion
Older Smoker Motivational InterventionChange in Motivation to Quit Within the Next 30 DaysBaseline Motivation to Quit within the next 30 days6.660 score on a scaleStandard Deviation 2.225
Older Smoker Motivational InterventionChange in Motivation to Quit Within the Next 30 DaysChange in Motivation to Quit within the next 30 days from Baseline to 6 Months Post-intervention-.6000 score on a scaleStandard Deviation 2.3002
Older Smoker Motivational InterventionChange in Motivation to Quit Within the Next 30 Days6 Months Post-intervention Motivation to Quit within the next 30 days7.133 score on a scaleStandard Deviation 2.4735
Control Motivational Message 1Change in Motivation to Quit Within the Next 30 DaysBaseline Motivation to Quit within the next 30 days6.10 score on a scaleStandard Deviation 2.845
Control Motivational Message 1Change in Motivation to Quit Within the Next 30 DaysChange in Motivation to Quit within the next 30 days from Baseline to 6 Months Post-intervention-.4222 score on a scaleStandard Deviation 2.91928
Control Motivational Message 1Change in Motivation to Quit Within the Next 30 Days6 Months Post-intervention Motivation to Quit within the next 30 days6.289 score on a scaleStandard Deviation 2.9666
Control Treatment as UsualChange in Motivation to Quit Within the Next 30 Days6 Months Post-intervention Motivation to Quit within the next 30 days6.209 score on a scaleStandard Deviation 2.9965
Control Treatment as UsualChange in Motivation to Quit Within the Next 30 DaysBaseline Motivation to Quit within the next 30 days6.31 score on a scaleStandard Deviation 2.852
Control Treatment as UsualChange in Motivation to Quit Within the Next 30 DaysChange in Motivation to Quit within the next 30 days from Baseline to 6 Months Post-intervention-.1628 score on a scaleStandard Deviation 3.28728
Control Motivational Message 2Change in Motivation to Quit Within the Next 30 DaysBaseline Motivation to Quit within the next 30 days6.34 score on a scaleStandard Deviation 2.616
Control Motivational Message 2Change in Motivation to Quit Within the Next 30 DaysChange in Motivation to Quit within the next 30 days from Baseline to 6 Months Post-intervention-.3111 score on a scaleStandard Deviation 2.0651
Control Motivational Message 2Change in Motivation to Quit Within the Next 30 Days6 Months Post-intervention Motivation to Quit within the next 30 days6.844 score on a scaleStandard Deviation 2.868

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026