NCT01921439

Brief Summary

The long-term goal is to improve the quality of life of children and their parents who smoke tobacco by facilitating parental smoking cessation in a way that is easy to administer yet effective. We aim to accomplish this goal by administering an interactive computer-based program that will facilitate motivation and readiness to engage in smoking cessation by providing personalized feedback about the financial and health effects of the parent's smoking. We will compare the changes in motivation and readiness to quit smoking after the parent has taken the computer-based program and compare them to the changes in motivation and readiness to quit in parents who receive only information about the Oklahoma Tobacco Helpline. We will also measure salivary cotinine levels in both parents and children, to objectively measure changes in smoking habits and secondhand smoke exposure. Our hypothesis is that our computer-based program will cause a greater increase in motivation and confidence to quit smoking in the group that receives the customized feedback than the group that receives only information about the Tobacco Helpline. We also predict that both parent and child cotinine levels will show a greater decrease in the group randomized to receive personalized feedback.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

3.4 years

First QC Date

August 8, 2013

Last Update Submit

April 7, 2017

Conditions

Keywords

smokingquit smokingsmoking cessationsmoking studysecondhand smokesmokers

Outcome Measures

Primary Outcomes (3)

  • Self-Reported Readiness and Motivation to Quit Smoking

    We will assess changes in self-reported readiness and motivation to quit smoking.

    Baseline, 1-month, 6-months, 12-months

  • Parent and Child Salivary Cotinine

    We will assess change in parent and child salivary cotinine throughout the course of the study.

    Baseline, 1-month, 6-months, and 12-months

  • Change in self-reported cigarette use

    We will assess changes in self-reported cigarette use throughout the study.

    baseline, 1-month, 6-months, and 12-months

Study Arms (2)

Feedback

ACTIVE COMPARATOR

Participants in this group will receive individualized feedback based on their stage of change. Feedback will include health effects of smoking, money spent per month and per year on cigarettes, time spent smoking compared with time spent doing other daily tasks, and how the participant compares to past study participants in average number of cigarettes per day used and level of addiction.

Behavioral: Personalized Feedback

No Feedback- Treatment as Usual (TAU)

NO INTERVENTION

Participants will take the computer based survey, but will only receive a number to the Oklahoma Tobacco Helpline (Treatment-as-usual condition) instead of feedback.

Interventions

Personalized feedback reflecting the participant's current level of nicotine addiction, money spent on cigarettes, time spent smoking, and health effects of smoking.

Feedback

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parent or primary caregiver of a child patient at the OU Children's Physicians General Pediatrics clinics
  • Current cigarette user
  • Able to read study forms and verbally communicate with the study staff in English

You may not qualify if:

  • Nonsmokers
  • Unable to read or speak English well enough to complete the survey and study tasks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

SmokingCigarette SmokingTobacco Use CessationSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorTobacco SmokingTobacco UseHealth Behavior

Study Officials

  • Stephen Gillaspy, Ph.D.

    The University of Oklahoma Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 13, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations