April 2000

Grant Results

SUMMARY

From 1996 to 1997, researchers at the Creighton University School of Medicine, Omaha, Neb., developed an interactive multimedia video program designed to assist low-income pregnant and postpartum smoking women to quit smoking.

Researchers also pilot tested the intervention on a sample of low-income pregnant smokers attending Women, Infants and Children (WIC) clinics in Omaha.

National surveys indicate that approximately 30 percent of all women in their childbearing years smoke cigarettes; many of them continue to smoke during pregnancy and child-rearing.

The interactive film modules were designed based on phone surveys of 49 WIC clients and three focus groups with 27 WIC clients as well as with WIC staff.

Key Results

  • Difficulties in the recruitment and retention of participants prevented the gathering of conclusive data about the intervention's effectiveness. The results, however, suggest that the intervention is worthy of further investigation, especially since it is potentially low cost and easy to disseminate.

Funding
The Robert Wood Johnson Foundation (RWJF) supported the project with a grant of $167,156 between February 1996 and December 1997.

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THE PROBLEM

National surveys indicate that approximately 30 percent of all women in their childbearing years smoke cigarettes; many of them continue to smoke during pregnancy and child-rearing. This not only affects their own health but that of their children as well, particularly unborn children, since smoking during pregnancy is connected with low birthweight. Pregnancy provides an excellent window of opportunity to help women quit smoking because of their concern for the health of their unborn children.

The Robert Wood Johnson Foundation's (RWJF) interest in smoking cessation in pregnancy led to its 1993 authorization of the Smoke-Free Families program (SFF), in which funding was to be provided for 10 two-year controlled studies of innovative smoking cessation interventions targeted at women of childbearing age. The program was renewed and expanded in 1998.

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THE PROJECT

This project planned to develop and test a multimedia software program designed to involve pregnant women in learning about the harmful effects of smoking, encourage them to quit smoking, assist them to progress through the stages of change, and help them avoid a return to smoking after delivery. The software program was to be interactive, adapting to the needs of pregnant women in the different stages of the quitting process, and placing the user in the active role of peer counselor.

The target population for the study consisted of low-income pregnant women enrolled in the Douglas/Sarpy County (Omaha, Neb.) Women's, Infants and Children (WIC) Program, a federal initiative to provide nutritional support and child care. About 32 percent of the pregnant women enrolled in this WIC program smoked during their pregnancies in 1992, according to CDC Pregnancy Surveillance Data from 1992. This project supported SFF's goals, but RWJF staff regarded this study as more preliminary than studies normally funded under SFF. Because the two efforts shared similar goals, RWJF included staff from this project in numerous SFF meetings.

Methodology

The study consisted of two parts. The first part was a "natural history" study designed to document the actual rate of smoking cessation in the target population as a result of the methods already utilized by the WIC program. The second part of the study would measure the responses of another group of pregnant women to the study intervention. Investigators also planned to document the actual costs of implementation to determine whether the intervention, if proven effective, could be reproduced at a low cost.

The collection of baseline data on a comparison group of pregnant WIC-clinic clients was intended to allow the investigators to provide benchmark data for estimating the likely efficacy of the study intervention. Quit rates for both groups were validated through saliva testing for cotinine (a byproduct of cigarette smoke), and the final result for both studies was the percentage of biochemically confirmed quitters at the end of pregnancy among the two groups.

The project was designed to take advantage of the structure of the WIC program. Women enrolled in the WIC program make monthly visits to pick up vouchers for food and child care. A study participant was expected to make at least four visits to the WIC clinic before the end of her pregnancy. On her first visit, project volunteers were to enroll her into either the natural history or intervention group, and test her saliva for cotinine, to biochemically confirm whether or not she was a smoker. On visits two and three, she would receive "usual care advice" if she were in the natural history group, or work with the interactive video program and receive printed messages if she were in the intervention group. She would undergo a final saliva test during her fourth visit to see if she was still smoking (members of both groups).

Project staff designed the interactive film modules based on phone surveys of 49 WIC clients and three focus groups with 27 WIC clients as well as two focus groups with WIC staff. The project also created an eight-minute videotape to give to new mothers who participated in the intervention group, encouraging them to be smoke-free. The modules were for use in the WIC clinics under the administration of WIC staff on CD-I format, which is a television screen attached to a compact disc (CD) player, and which permits full-motion video. The program is activated by touching the television screen.

The video offers three pathways to fit three different stages of a woman's readiness to change smoking behavior: someone not yet considering quitting, someone considering quitting, and someone trying to quit. The participant answers questions at the beginning of the module to determine the pathway she will follow. Each of these pathways involves participation in role-playing soap-opera-like scenarios in which the participant takes on the role of an advisor to characters in the videos facing a variety of common, real-life situations. One scenario involves, for example, a young African-American woman who works in a day care center, and just found out she is pregnant. She is trying to decide whether or not to quit smoking. The participant is given the choice of advising the character, or requesting expert advice from the software program to learn more about the problem. Participants indicate their choices by pushing a button. The characters in the scenario complain if they are given bad advice, and prompt the participant to learn more. This "active advisor" methodology was employed to increase the user's sense of involvement in the learning, and of control over similar issues in her own quitting struggles.

The script was designed for a sixth-grade reading level, and the dialogue boxes or lines of the text are read by a narrator. The text being read also is highlighted to help participants who have may poor reading skills. These factors might enable the intervention, if proven successful, to supplant or complement more expensive, labor-intensive interventions, such as face-to-face counseling.

The five participating WIC clinics in Douglas County, NE, served clients from a variety of ethnic/racial groups, the majority of whom were between ages 20 and 35, and had completed education through middle school. Study participants were recruited from pregnant WIC clients who smoked. The investigators hoped to recruit a group of 120 women for the pilot study of the interactive film intervention, as well as another group of 120 for the natural history baseline study.

Delays in the recruitment and difficulties in the retention of study participants were the project's principal problems. Recruitment targets were almost reached, but a large number of participants in each study dropped out before the end (see Results). Reasons for the difficulty in recruitment and retention of participants included:

  • The proposal called for the intervention to be conducted in the WIC clinics by WIC employees. The employees, however, were reluctant to take on this extra responsibility, and there were fewer employees following a 15 percent budget cut in January 1997. In the end, personnel from the medical school had to come in and administer the intervention. Volunteers were recruited for this, but the unforeseen drain on the grantee organization's personnel time was substantial.
  • The investigators realized only midway through the trial that they needed incentives to induce participants to join and stay with the study. While they did devise and try out an incentive system, it was an extra expense which they had not foreseen or included in their budget.
  • The WIC clinic population presented a challenge to retention because many of the women moved frequently and/or did not have telephones.

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RESULTS

The results were as follows:

Project Group Patients Recruited Patients Retained Confirmed Quitters (%)
Natural History 119 75 3 (4%)
Intervention 114 79 8 (10%)

The 10 percent biochemically confirmed cessation rate for the intervention was greater than the 4 percent rate in the natural history portion of the investigation. Because of the very low numbers of quitters, however, the difference was not statistically significant. Since the intervention's efficacy remains to be established, plans for cost analysis and a study of cost-effectiveness have not yet been carried out. The investigators did succeed, however, in transforming an innovative idea into an actual intervention that is still in the process of being refined. They also gained experience in the recruitment of participants and implementation of the intervention, which could prove useful in future trials. Project staff believe the results suggest that this intervention may be useful and worth a follow-up, especially because it is potentially low cost, relatively easy to distribute, and designed for low-income women.

Communications

No significant dissemination has occurred. The researchers plan to submit an article based on this pilot study for publication in an academic journal such as the American Journal of Public Health. To assist in disseminating findings, RWJF staff are organizing a supplement to the journal Tobacco Control, to be published in mid-2000, which will contain discussions of results and lessons learned from this and the projects in the RWJF national program, Smoke Free Families (SFF) (ID# 037567).

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LESSONS LEARNED

  1. The recruitment and retention of trial participants is expensive and time-consuming. For future trials of this sort it should be assumed that incentives may be needed for participant recruitment/retention, and/or that grantee personnel may be needed to conduct the trial. Moreover, eligible settings must be able to demonstrate the necessary staffing and organizational capabilities to assure research and treatment implementation. Time for a trial recruitment and research period is also likely to prove helpful.

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AFTER THE GRANT

Following this project, RWJF, through the evaluation of SFF (ID# 032822) being conducted by Robert L. Goldenberg at the University of Alabama at Birmingham School of Medicine, provided support to Walter J. Scott, M.D., the principal investigator of this grant, and each grantee organization in SFF to address difficulties in the implementation of smoking cessation trials targeted toward pregnant smokers, particularly concerning recruitment and retention of participants.

Under this project, Scott and the other investigators conducted focus groups and surveyed random participants and WIC employees from the original study asking for suggestions for improvement. Participants made suggestions for structural changes to make the intervention easier for people to use and more relevant to their lives. The investigators also probed the attitudes of the WIC staff to learn more about the difficulties they encountered in working with WIC participants/staff and discovered that WIC staff see their role as primarily a nutrition program and do not generally see the relevance of a smoking cessation program.

In response to a National Cancer Institute request for proposals for novel cancer control interventions using new communications media, the principal investigator submitted a proposal for a larger clinical trial of this intervention.

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GRANT DETAILS & CONTACT INFORMATION

Project

Interactive Videos on Smoking Cessation for Pregnant Women and Their Families

Grantee

Creighton University School of Medicine (Omaha,  NE)

  • Amount: $ 167,156
    Dates: February 1996 to December 1997
    ID#:  028495

Contact

Walter J. Scott, M.D.
(402) 280-4139

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BIBLIOGRAPHY

(Current as of date of this report; as provided by grantee organization; not verified by RWJF; items not available from RWJF.)

Audio-Visuals and Computer Software

"Smoking Cessation: So What's New?" (Eight-minute videotape given to new mothers). Omaha, Neb., 1997.

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Report prepared by: David Gray
Reviewed by: Susan G. Parker
Reviewed by: Janet Heroux
Program Officer: C. Tracy Orleans