A Feasibility Study of Smoking Cessation Utilizing an Exercise Intervention Among Black Women: ‘Quit and Fit’

Abstract

Background:

Women who engage in higher levels of exercise while trying to quit smoking have been shown to be less likely to relapse and to sustain their smoking abstinence longer. This study sought to examine the benefits of exercise for improving smoking cessation among Black women.

Methods:

We evaluated the feasibility of a 12-week smoking and exercise intervention, Quit and Fit, tailored for Black women. All participants (intervention and control) received 12 weeks of smoking cessation counselling via telephone and 9 weeks of nicotine lozenges. Participants who were randomly assigned to the intervention condition were also assigned to a 12-week exercise group.

Results:

Thirty-eight women were enrolled and 27 completed a 12-week follow-up assessment. Women from the intervention group were more likely to complete the 12-week follow-up assessment compared to participants in the control group (80% vs. 61%). Overall, 7 of the 38 participants (18%) were abstinent at 12 weeks (biochemically verified by expired carbon monoxide). Among the 25 women who completed the 12-week follow-up, abstinence was reported in 33% of the intervention group and 20% of the control group. Using an intent-to-treat approach, 25% of women in the intervention group were abstinent at 12 weeks (n =5), compared to 11.1% for the control group (n=2). These differences were not statistically significant.

Conclusions:

The overall retention rate was 71% (27/38) at 12 weeks with higher among the intervention group (16/20; 80%) compared to the control group (11/18; 61%). The study demonstrates that it is feasible to retain African-American women in a short-term study of smoking cessation and exercise.

1.1. INTRODUCTION

Smoking is the leading cause of preventable morbidity and mortality in U.S. Blacks.¹ Disparities exist in disease and death from smoking-related diseases.^2,3 Research that focuses on smoking in Black women is important because, compared to their White female and Black male counterparts, Black women carry a disproportionate tobacco-related disease burden.⁴ In particular, Black women have lower smoking rates compared to US White women, yet similar lung cancer rates.^5,6

Smoking cessation is the single most important preventive health behavior Black women can engage in to significantly reduce their chances of morbidity and premature mortality related to smoking-related illnesses.⁷ Although more men smoke than women, data show that women may be less successful at quitting than men⁸. Intensive smoking-cessation programs may be necessary to promote smoking abstinence in women who have difficultly quitting.⁹ Wilson et al¹⁰ suggest that interventions are most effective when an attempt is made to modify a number of lifestyle behaviors. For example, exercise has been used as an adjunct to smoking cessation interventions because it has been shown to reduce cigarette cravings, withdrawal symptoms and weight gain^{11, 12} all of which are barriers to smoking cessation among women.¹³

The Commit to Quit study¹⁴ examined the benefits of exercise for smoking in a group of 60 sedentary women. There was a trend toward higher rates of abstinence in the exercise group compared to controls. However, the results were not statistically significant. Further exploration of the data found that, among women randomized to the exercise intervention, greater attendance at exercise sessions was associated with higher rates of abstinence at the end of the study. Commit to Quit was studied in a larger group of women (N=330) in a YMCA setting.¹⁵ Results were similar to the pilot study. There was no difference in quit status between the exercise and control groups. However, participation in more exercise sessions was associated with greater odds of quitting.

Spring et al¹⁶ conducted a review of 10 randomized controlled trials to determine whether behavioral weight-control interventions improved smoking cessation attempts and whether they were effective in reducing weight gain post-cessation. With regards to abstinence, combined smoking plus weight-control treatment was associated with significantly higher short-term abstinence (<3 months) compared with smoking cessation alone. However, no differences were observed for long-termed abstinence (> 6 months). Similarly, Ussher et al¹⁷ conducted a review of 15 randomized controlled trials to assess the effectiveness of exercise as an aid to smoking cessation. Only one study showed evidence that exercise assisted smoking cessation in the long term (>6 months abstinence). Rates of adherence to exercise may be an explanatory factor in the lack of observed associations between exercise and smoking cessation outcomes. Ussher et al¹⁷ concluded that more research is necessary to determine if exercise is a beneficial aid to smoking cessation.

In the Commit to Quit pilot, most women (83%–86%) were non-Hispanic white. In the YMCA trial, 22% were identified as “minority”; however the specific racial/ethnic make-up of the group was not reported. It is important that research to improve the understanding of the potential role of exercise in smoking cessation include diverse participants. While studies that help to identify differences between varied demographic groups are useful, it’s equally important conduct research that focuses specifically on the experiences within groups. This study fills a gap in the research by examining whether exercise enhance smoking cessation specifically among Black women.

1.1. Theory

Culturally tailored comprehensive interventions that address smoking-cessation among Black women are needed¹⁸ According to the Theory of Planned Behavior (TPB),¹⁹ intention is the most proximal predictor of behavior. Cognitions affecting intention are attitudes, subjective norms, and perceived behavioral control/self-efficacy. Self-efficacy is described as one’s competence to perform future behavior.

The recruitment materials were designed to reflect diverse African American women. Participants encountered other Black women as study participants, staff, and investigators. Having significant representation of Black women throughout the study was expected to address the subjective norms of smoking cessation as a health promotion target that was socially normative for Black women. Women identified their personal reasons for quitting. Identifying personal goals may help to shape personal intentions as well as motivations. Self-efficacy and behavioral control were addressed through an intervention design that allowed women to gradually change both behaviors. Smoking cessation counseling allowed planning for a quit date that was selected by the participant. Smoking lapses were normalized as part of the process of quitting which allowed women to have a sense of control of how they responded to the lapse. The exercise component of this study allowed participants to gradually increase their exercise intensity and duration. This graduated exercise prescription enabled participants to build confidence, over the course of the study, in their ability to achieve the recommended exercise goal.

The purpose of this study was to examine the feasibility of recruiting and retaining participants in a structured health promotion program that focused on improving smoking cessation self-efficacy, in African-American women smokers. The program consisted of telephone counselling for smoking cessation coupled with a supervised exercise program. In addition to assessing feasibility of recruitment and retention, we sought to examine how a targeted program to promote smoking cessation and exercise could improve smoking cessation rates.

2.1. MATERIALS AND METHODS

2.2. Study Design:

This is a randomized controlled trial with two arms: exercise intervention (EI) and a control arm. Assessments were measured at three time points: Baseline, at week 6 and 12-week of the intervention. This study was approved by the educational institution’s Institutional Review Board.

2.3. Study Population:

The population of interest for this study was African-Americans who met the following eligibility criteria: (1) women ages 18–69 years; (2) currently smoke at least 5 cigarettes per day; (3) smoked daily for the past one year; (4) able to provide informed consent; (5) able to participate in exercise training as determined by self-reported ability to walk and a graded fitness test conducted at the study site. Participants were excluded if they self-reported one or more of any of the following conditions: (1) pregnant; (2) unstable angina; (3) heart disease; (4) advanced pulmonary disease; (5) arthritis or other orthopedic problems; (6) diagnosed with an eating disorder or a body dysmorphic disorder (7) poorly controlled psychiatric illness; (8) self-reported illicit drug use or alcohol dependence (measured by the CAGE) in past 90 days; (9) enrolled in another study.

2.4. Study Arms

2.4.1. Exercise Intervention Arm:

Women randomized to the exercise arm received 9 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges; 12 weeks of behavioral counseling for smoking cessation; and 12 weeks of a structured exercise intervention. Anecdotal experience among the study team with conducting smoking programs with Black participants noted that lozenges were an acceptable option among the over-the-counter FDA-approved cessation medications. Cognitive behavioral counselling for smoking cessation was provided by phone by a research assistant trained to use a standardized intervention protocol developed by authors CS and CDW. Telephone counselling sessions lasted approximately 30 minutes and incorporated key topics including the health effects of smoking, stress management, general relapse prevention, healthy dietary practices and the benefits of regular physical activity. Participants in the program adhered to a uniform quit date occurring during the third week of the intervention.

In addition, all women in the exercise arm were offered structured exercise sessions supervised by an exercise physiologist. The sessions included aerobic activities such as walking/running on a treadmill or pedalling on a stationary bicycle. Exercise sessions were conducted at our community-based research office. Participants were encouraged to take advantage of the maximum number of exercise sessions which consisted of up to 50 minutes per session, 3 days/week for 12-weeks. Exercise intensity and duration increased gradually from 60 min/week, 50–55% VO2max to 150 min/week, 65–74% VO2max, by week 4, using American College of Sports Medicine (ACSM) guidelines²⁰ for exercise progression. Thereafter, all participants maintained >150 min/week of moderate-intensity physical activity. The exercise intervention was performed between 50–70% of their VO2max, as determined during baseline testing and with a rating of perceived exertion (RPE) of 11–14 on the 20-point scale. Participants were given Polar health rate monitors to use throughout the exercise sessions to monitor heart rate and were taught how to use the RPE to determine the appropriate moderate exercise intensity during the exercise intervention. Heart rate, RPE (intensity), and any general comments/questions were recorded for each session.

2.4.2. Control Arm:

Women randomized to the control arm received 9 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. They also received the same 12-week standardized phone-based smoking cessation counselling program as women in the exercise arm including setting a uniform quit date occurring during the third week of the intervention. Women in the control arm were asked to maintain their current individual activity levels over the course of the 12-week study.

2.5. Measures:

Demographics and Smoking history:

Demographic data including sex, age, marital status, race/ethnicity, and employment status, education and household income were collected. Information on smoking history including years of smoking, number of cigarettes currently smoked per day, and type of cigarettes (light, ultralight, vs. full flavor and menthol vs. non-menthol) were also collected at baseline visits. The Fagerström Test for Nicotine Dependence (FTND)²¹ was used to measure nicotine dependence.

Physiological Measures:

Blood pressure and heart rate were measured after five minutes of rest in a seated position. Height and weight measurements were conducted on all participants while wearing light indoor clothing without shoes. Height measurements were taken using a stadiometer and weight was taken on a standard digital scale. Cardiovascular fitness was assessed by measuring maximal oxygen consumption (VO2max). The Bruce treadmill protocol was used to determine VO2max using a ParvoMedics TrueOne 2400 metabolic cart (Sandy, UT). This test involved a five-minute warm-up followed by increases in treadmill speed and grade every three minutes until volitional exhaustion. Heart rate and respiratory variables (ml/kg/min) were measured continuously during exercise and recovery. VO2max was measured at baseline, and 12 weeks in all subjects.

Biochemical Validation:

Expired air carbon monoxide was used to confirm smoking status in each participant and measured using a Vitalograph’s BreathCO carbon monoxide monitor (Model 2970). Each participant was instructed to take a deep breath, hold it for 10 seconds and then breath out slowly through the mouthpiece to allow for an accurate reading. A reading of ≤10 ppm was used as the cut-off to verify smoking status among those who self-reported abstinence at 6 and 12 weeks.

Fidelity to Intervention:

Tobacco cessation telephone counsellors captured fidelity to intervention by documenting each session using a session note listing each target message. In addition to the target messages for the session, counsellors made notations of additional topics discussed, as needed.

2.6. Nicotine Replacement therapy:

Based on manufacturer guidelines, participants who smoked the first cigarette of the day within 30 minutes were provided with 4mg lozenge. Those who had their first cigarette more than 30 minutes after waking received the 2mg dosage. Participants began using lozenges at week three (quit week) and were educated on proper lozenge use. Women were instructed to use 1 lozenge every 1 to 2 hours for weeks 1–6, then 1 lozenge every 2 to 4 hours for weeks 7–9 and 1 lozenge every 4 to 8 hours for weeks 10–12. Lozenges were picked up by participants at the study site and were resupplied at in-person visits at weeks 6 and 9.

2.7. Enrollment, Adherence and Retention:

Participants were recruited from October 2013 through June 2014. Recruitment occurred in locations throughout the Washington, DC metropolitan area, with emphasis placed on neighbourhoods with documented cancer disparities for women as well as with higher rates of poverty and unemployment and limited access to health services. Enrollment Participants were asked to identify personal goals at the beginning of the program and these goals were used as motivators to continue and complete the program. On enrollment into the study, participants were asked to provide primary and alternate phone numbers to facilitate retention in the counselling intervention and follow-up visits; counsellors arranged the scheduled phone calls at times and phone numbers that were convenient for the patients. If a participant was unreachable after three attempts, counsellors utilized the alternate contact number given at enrollment. In addition, an incentive program was used to enhance retention. Participants received monetary incentives for completing data collection measures at baseline and 12-week follow-ups. Participants received a $25 gift card after the baseline visit to the study site. A second $25 gift card was provided at study completion (12 weeks) upon participants reporting to the site to complete final assessments. At the end of the study, participants were asked to reply to open-ended questions to gather data about their experience: “What made it difficult for you to participate in the Quit and Fit program?” and “Do you have any suggestions for improving the Quit and Fit program?” Participants were also asked to rate how “Helpful” the program was, how well the program “met expectations” and overall satisfaction with the program. These questions were answered on a scale of 1 to 5 where 1 was “Not at All” and 5 was “Extremely.”

2.8. Statistical Analysis:

Descriptive statistics (frequencies, percentages, means and standard deviation) were calculated for baseline variables. Baseline and 12 weeks (end of intervention) data were compared using the chi-squared test.

4.1. RESULTS

4.2. Study population:

A total of 38 participants were enrolled in the study. The demographic characteristics of the study population are shown in Table 1. On average, participants were 51 years old, single, high school graduates with some vocational or college experience. Participants smoked an average of about 13 cigarettes per day (> one-half pack per day) with an average age of smoking initiation of about 18 years (Table 1).

Table 1.

Baseline Characteristics of Sample (N = 38) (Full Sample)

Demographics	Overall	Intervention n = 20 (53%)	Control n = 18 (47%)	p-value
Age (years) (Mean; SD)	51.24 (7.7)	49.70 (8.25)	52.94 (6.88)	.20
Marital Status N (%)
Married/With Partner	5 (13%)	3 (15%)	2 (11.1%)	.68
Single/Divorced/Widowed	32 (84%)	16 (80%)	16 (88.9%)
Missing	1 (2.6%)	1 (5%)
Education N (%)
≤ High School Diploma	18 (47.4%)	7 (35%)	11 (61.1%)	.10
Associates Degree or Higher	18 (47.4%)	12 (60%)	6 (33.3%)
Missing	2 (5.2%)	1 (5.0%)	1 (5.6%)
Income N (%)
Less than 50K/year	24 (63.1%)	13 (65%)	11 (61.1%)	.76
≥ $50k/year	10 (26.3%)	6 (30%)	4 (22.2%)
Missing	4 (10.5%)	1 (5%)	3 (16.7%)
Smoking History (Average age of first cigarette) (Mean; SD)	17.92 (8.23)	17 (4.81)	18.94 (10.92)	.48
Preference for Cig Flavor
Menthol N(%)	31 (81.6%)	16 (80%)	15 (83.35)	.79
Regular N(%)	7 (18.4%)	4 (20%)	3 (16.7%)
Dependence (Fagerstrom) (Mean, SD) (0= very low dependence to 10=very high dependence)	4.80 (2.52)	4.9 (2.3)	4.7 (2.8)	.89
Motivation to Quit (Mean, SD) (1=I’ve decided to quit for my lifetime to 10 =I’ve quit and will never smoke again)	7.23 (1.55)	7.4 (1.3)	7 (1.8)	.43
Self-efficacy to Quit (Mean, SD) (1= not at all tempted to 5=extremely tempted)	3.72 (.74)	3.8 (.68)	3.7 (.80)	.68
BMI	30.18 (7.44)	30.28 (8.26)	30.06 (6.7)	.93
Weight	182.95 (50.34)	177.95(57.58)	188.50 (41.81)	.53
WHR	.86 (.07)	.86 (.08)	.86 (.05)	.87
VO2max	22.23 (6.54)	21.33 (7.10)	23.40 (5.97)	.47
SBP	128.45 (16.99)	128.35 (18.80)	128.56 (15.26)	.97
DBP	84.42 (13.82)	82.25 (14.21)	86.83 (13.36)	.31
HR	80.40 (13.05	81.90 (14.23)	78.72 (11.78)	.46

4.3. Recruitment and Retention:

Figure 1 outlines information regarding recruitment, enrollment, randomization, and 6- and 12-week follow-up retention rates. The targeted sample size was 40. Since this was a feasibility study, it was not powered to detect efficacy of the intervention. Recruitment occurred over a 10-month period. A total of 98 potential participants expressed interest in the study. Among the potential participant pool, 38 (38.8%) were consented and enrolled into the study. Among the women who did not enroll, 32 (32.7%) were ineligible. Twenty-two (22.4%) did not attend the scheduled enrollment visit or did not respond after three attempts to schedule an enrollment visit. Four (4.1%) declined and reason for not enrolling was not documented for two potential participants (2.0%).

Figure 1.

Recruitment and Retention Flowchart

Of the 38 enrolled participants, 20 participants were randomized to the intervention group and 18 to the control group. Eighteen women completed the 6-week follow-up visit telephone visit (7 from the control group and 11 from the intervention group). Women had the option to complete the 6-week appointment in person if they required a refill of lozenges. However, due to low rates of lozenge use, all visits were completed by phone. By the 12-week follow-up, nine additional participants had been re-engaged resulting in 27 participants responding to the 12-week follow-up (16 from the intervention group and 11 from the control group). Thus, the overall retention rate for the entire sample was 71% (27/38) at 12 weeks. Retention of participants through the 12-week follow-up was higher among the intervention group (16/20; 80%) compared to the control group (11/18; 61%). However, this difference was not statistically significant (chi square = 1.645, p = .288).

4.4. Adherence

We examined overall adherence to components of the study protocol. Adherence to the 12 telephone counseling sessions offered ranged from zero to 12 with a mean of 4.8 telephone sessions completed (SD = 4.4). At the 12-week follow-up, women were asked to estimate how many days did they use nicotine lozenges over the 90-day study period. The reported range was zero to 60 days with a mean of 13.9 days (SD = 20.2). Among women randomized to the exercise group, the average number of exercise sessions attended over the 12-week period was 3.4 (SD= 5.8) of 36 available exercise sessions.

Adherence did not differ among intervention and control group participants. The control group completed an average of 5.9 (SD =4.7) phone sessions compared to 3.8 (SD = 3.9) completed by women in the intervention group (t = 1.525, p = .136). While average days of lozenge use reported by women in the control group was 30.3 (SD = 29.5) compared to 5.7 (SD = 7.8) days of lozenge use reported by women in the exercise intervention group, this difference was not statistically significant (t = 2.037, p - .081).

Table 2 compares intervention adherence by abstinence status. There was no difference in adherence to telephone counseling or exercise attendance by abstinence status at 12-week follow-up. While women who were abstinent at 12-weeks reported more lozenge use compared to women who were still smoking, this difference was not statistically significant.

Table 2.

Intervention adherence by abstinence status

	Abstinent	Smoking	p-value
	Mean (SD)	Mean (SD)
Mean phone sessions (mean, SD)	6.57 (3.99)	4.42 (4.46)	.248
Mean days of lozenge use (mean, SD)	17.75 (28.28)	10.80 (13.81)	.641
Mean exercise sessions (mean, SD)	5.00 (6.40)	2.87 (5.76)	.493

4.5. Smoking Cessation:

Although this study was not powered to test efficacy of the intervention, smoking cessation was assessed by 7-day point prevalence by asking, “Have you smoked, even one puff, in the past 7 days?” There was no association between the intervention arm and smoking cessation. Among the 25 women who completed the 12-week follow-up, 5 of 15 women (33.3%) in the intervention group reported abstinence compared to 2 of 10 women (20.0%) of the control group (Chi square = 0.529, p=467). Using an intent-to-treat approach, 25.0% of women in the intervention group were abstinent at 12 weeks (n =5), compared to 11.1% for the control group (n=2) (Chi square = 0.270, p = .410).

4.6. Participant Satisfaction:

When asked how helpful the program was and how well the program met expectations, 18 of 27 participants (47.4%) who responded to those questions at the 12-week follow up rated the program as “very helpful” or “extremely helpful”. Seventeen participants (44.8%) were either “very satisfied” or “extremely satisfied” with the program. Nearly all women 26/27 (96.3%) said they would “recommend Quit and Fit to family or friends who want to quit smoking.

When asked how the Quit and Fit Program could be improved (via an open-ended questionnaire), several themes emerged. For example, several participants suggested that access to the exercise facility could be expanded to address time barriers, scheduling conflicts and distance from exercise facility. Suggestions were also made to offer more NRT options including e-cigarettes, flavored lozenges, patches, as well as the option to select preferred NRT type. It was suggested that group-based exercise classes could be offered to foster social support from other participants. Finally, participants were asked what made it difficult for them to participate in the Quit n Fit program. Managing physical limitations and personal/unexpected stresses were noted as barriers to participation.

5.1. DISCUSSION

This study sought to determine the feasibility of enrolling and retaining urban African American women in a program that includes exercise as part of a smoking cessation intervention. Women’s response to the study approach would determine whether a larger efficacy trial would be warranted.

Adherence to each study component varied. There was moderate adherence to the telephone counseling sessions. On average, participants completed an equivalent of of 12 weeks of phone counseling. Adherence was lower for lozenge use and exercise. Overall, women only used lozenges for an equivalent of about 2 of 12 weeks and attended exercise sessions for approximately one week. The project was able to retain about two-thirds of participants in the study for 12 weeks. While we employed several methods to promote retention, it is evident that this aspect of the study could be improved. While levels of adherence were low to moderate, women have generally favorable views of the program.

5.2. Limitations

The study was designed as a feasibility assessment to understand capacity to recruit and retain African American women to an exercise-based intervention for smoking cessation. Thus, it was not powered to assess efficacy. Future studies should be adequately powered to assess the efficacy of the intervention components.

To verify quit status based on expired carbon monoxide reading, we used a cut-off of ≤ 10 ppm. It has been suggested that this cut-off may overestimate true abstinence rates by as much as 19%.²² Some research has shown certain medical comorbidities have been associated with higher levels of expired carbon monoxide (e.g. asthma, COPD, diabetes).²³ Second-hand smoke exposure can also produce elevated readings. Black women report more second-hand smoke exposure than women of other ethnicities.²⁴ Thus, we opted for a higher cut-off to avoid misclassifying women who had achieved abstinence, but may have other health or environmental factors that would impact their carbon monoxide levels. More stringent criteria for biochemical verification of smoking abstinence could be applied.

The study did not offer a flexible menu of options. Only supervised exercise using treadmills and stationary bikes was offered. The only form of NRT offered was unflavored lozenges. Another limitation was lack of assessment of actual exercise or physical activity levels that participants may have engaged in outside of the study setting.

The study was intended to be ecologically valid and reflect how women might be engaged in these behavior change goals in a community setting. As such, the community engagement process could have been enhanced by providing useful information to participants at the conclusion of the study, such as screening guidelines for lung and colon cancers. Engagement could have also been enhanced by providing participants with a study summation in plain language. These approaches should be part of optimal participant engagement in future clinical research studies.

5.3. Implications

To address the tobacco-related disparities faced by Black women, it is necessary to tailor programs to fit their diverse preferences and needs. Future research should examine enhanced means of tailoring interventions to improve adherence and outcomes. Based on the barriers identified by participants and recommendations for improving the program, future efforts should seek to match women with their preferred type of exercise (e.g. home-based, group classes, etc.) as well as the preferred means of smoking cessation modality (type of NRT, phone vs. group sessions, or use of electronic media).