Effects of Smoking Reduction and Cessation on Birth Outcomes in a Scheduled Gradual Reduction Cessation Trial.

INTRODUCTION: Smoking during pregnancy can affect infant birthweight. We tested whether an intervention that promoted scheduled gradual reduction improved birth outcomes among pregnant women who smoked. We also examined race differences in birth outcomes. METHODS: We conducted a 2-arm randomized controlled trial where pregnant women who smoked received either SMS text-delivered scheduled gradual smoking reduction (SGR) program plus support texts or support messages only throughout their pregnancy. The outcomes for this paper were birth outcomes including birth weight and gestational age obtained from chart review. Analyses were conducted using chi-square and t-tests in SAS. RESULTS: We approached 2201 pregnant women with smoking history. Of the 314 women recruited into the study, 290 completed a medical release form (92%). We did not find any significant differences in birth outcomes by arm or race. The majority of participants reduced smoking by the 80%. Women who reduced more than 50% of their baseline cigarettes per day had a birth weight increase of 335 g compared to those that did not (p = 0.05). The presence of alcohol/drug use in prenatal visit notes was associated with low infant birth weight (p = 0.05). DISCUSSION: The scheduled gradual reduction intervention did not improve birth outcomes. Additional research is needed to help improve birth outcomes for pregnant women who engage in tobacco and illicit substance use. CLINICAL TRIAL #: NCT01995097.

Trajectories of Situational Temptations in Pregnant Smokers participating in a Scheduled Gradual Reduction Cessation Trial.

OBJECTIVE: The purpose of this paper was to examine changes in situational temptations to smoke among women in early to late pregnancy enrolled in a texting trial to help them quit smoking. We compared changes between (1) intervention arms, (2) those who quit, (3) those who reduced by 50% or more, and (4) those who reduced by less than 50%. We also examined cravings overtime in the intervention arm and the relationship between real-time cravings assessed via text message and situational temptations. METHODS: This was a secondary analysis of the Baby Steps trial, a randomized controlled trial testing the efficacy of a text-based scheduled gradual reduction (SGR) intervention on cessation. We used t-tests to examine changes across intervention arms and repeated measured proc mixed to explore changes in situational temptations and cravings. RESULTS: Among all women, situational temptations decreased from early to late pregnancy for the positive, negative, and habitual subscales, (ps < 0.001). We found no difference in situational temptations across arms. We found a positive relationship between negative situational temptation and average craving during the Weeks 2 and Weeks 3 of the intervention. Negative ST increased by 0.11 for each unit increase of craving at Week 2. CONCLUSIONS: As women progress through pregnancy their temptation to smoke reduces. A different relationship might exist, however with negative affect situations in which women reported higher craving but not in response to other temptations. Future work might have a particular focus on the intersection of negative affect with cravings and temptations to promote cessation during pregnancy. CLINICAL TRIAL: NCT01995097.

Efficacy of a Texting Program to Promote Cessation Among Pregnant Smokers: A Randomized Control Trial.

INTRODUCTION: Smoking during pregnancy poses serious risks to baby and mother. Few disseminable programs exist to help pregnant women quit or reduce their smoking. We hypothesized that an SMS text-delivered scheduled gradual reduction (SGR) program plus support texts would outperform SMS support messages alone. METHODS: We recruited 314 pregnant women from 14 prenatal clinics. Half of the women received theory-based support messages throughout their pregnancy to promote cessation and prevent relapse. The other half received the support messages plus alert texts that gradually reduced their smoking more than 3-5 weeks. We conducted surveys at baseline, end of pregnancy, and 3 months postpartum. Our primary outcome was biochemically validated 7-day point prevalence abstinence at late pregnancy. Our secondary outcome was reduction in cigarettes per day. RESULTS: Adherence to the SGR was adequate with 70% responding to alert texts to smoke within 60 minutes. Women in both arms quit smoking at the same rate (9%-12%). Women also significantly reduced their smoking from baseline to the end of pregnancy from nine cigarettes to four; we found no arm differences in reduction. CONCLUSIONS: Support text messages alone produced significant quit rates above naturally occurring quitting. SGR did not add significantly to helping women quit or reduce. Sending support messages can reach many women and is low-cost. More obstetric providers might consider having patients who smoke sign up for free texting programs to help them quit. IMPLICATIONS: A disseminable texting program helped some pregnant women quit smoking.Clinical Trial Registration number: NCT01995097.

Pilot Test of Connecting Pregnant Women who Smoke to Short Message Service (SMS) Support Texts for Cessation.

INTRODUCTION: Most pregnant women know that smoking poses serious risks to baby and mother, yet many still smoke. We conducted a large randomized controlled trial and found that an SMS text-delivered program helped about 10% of these women quit smoking. In this paper, we describe the feasibility of disseminating a text-based intervention to pregnant women who smoke. METHODS: We tested dissemination in two ways from prenatal clinics and compared recruitment rates to those found in our large randomized controlled trial. The first method involved "direct texting" where study staff identified women who smoked and sent them a text asking them to text back if they wanted to receive texts to help them quit. The second involved "nurse screening" where clinic staff from county health departments screened women for smoking and asked them to send a text to the system if they wanted to learn more about the program. Our primary outcome was feasibility assessed by the number of women who texted back their baby's due date, which served as "enrolling" in the texting program, which we compared to the recruitment rate we found in our large trial. RESULTS: Over 4 months, we texted 91 women from the academic health system. Of those, 17 texted back and were counted as "enrolled." In the health departments, across the 4 months, 12 women texted the system initially. Of those, 10 were enrolled. This rate was similar to the rate enrolled in the randomized controlled trial. DISCUSSION: Two different methods connected pregnant women who smoke to a texting program. One of these methods can be automated further and have the potential of helping many women quit smoking with minimal effort. Clinical Trial # NCT01995097.

Efficacy of a Nurse-Delivered Intervention to Prevent and Delay Postpartum Return to Smoking: The Quit for Two Trial.

INTRODUCTION: Most pregnant women who quit smoking return to smoking postpartum. Trials to prevent this return have been unsuccessful. We tested the efficacy of a nurse-delivered intervention in maintaining smoking abstinence after delivery among pregnant women who quit smoking that was tailored on their high risk of relapse (eg, had strong intentions to return). METHODS: We recruited 382 English-speaking spontaneous pregnant quitters from 14 prenatal clinics and randomized them to receive either a smoking abstinence booklet plus newsletters about parenting and stress (control) or a nurse-delivered smoking abstinence intervention that differed in intensity for the high and low risk groups. Our primary outcome was smoking abstinence at 12 months postpartum. RESULTS: Using intent-to-treat analyses, there was a high rate of biochemically validated smoking abstinence at 12 months postpartum but no arm differences ( CONTROL: 36% [95% confidence interval [CI]: 29-43] vs. INTERVENTION: 35% [95% CI: 28-43], P = .81). Among women at low risk of returning to smoking, the crude abstinence rate was significantly higher in the control arm (46%) than in the intervention arm (33%); among women at high risk of returning to smoking, the crude abstinence rate was slightly lower but not different in the control arm (31%) than in the intervention arm (37%). CONCLUSIONS: Low-risk women fared better with a minimal intervention that focused on parenting skills and stress than when they received an intensive smoking abstinence intervention. The opposite was true for women who were at high risk of returning to smoking. Clinicians might need to tailor their approach based on whether women are at high or low risk of returning to smoking. IMPLICATIONS: Results suggest that high-risk and low-risk women might benefit from different types of smoking relapse interventions. Those who are lower risk of returning to smoking might benefit from stress reduction that is devoid of smoking content, whereas those who are higher risk might benefit from smoking relapse prevention.

Predictors of pregnant quitters' intention to return to smoking postpartum.

INTRODUCTION: Although many pregnant women quit smoking, most return to smoking postpartum. Returning to smoking is strongly related to women's stated intention about smoking during pregnancy. We examined factors related to women's intention to return to smoking to improve intervention trials. METHODS: We report cross-sectional baseline data from a randomized controlled trial to prevent postpartum return to smoking. Women (n = 382; 98% consent rate) were English-speaking women who smoked at least 100 cigarettes in their lifetimes and at least 5 cigarettes a day prior to becoming pregnant. We fit logistic regression models to test whether women's intention to return to smoking was associated with demographic and smoking factors such as race, parity, and smoker self-identity. RESULTS: Forty-three percent of women had a strong intention of returning to smoking. Factors independently associated with intending to return to smoking were: stating they did not want to be currently pregnant (OR = 2.1, CI = 1.1-3.9), reporting being abstinent for fewer days (OR = 0.8, CI = 0.7-0.9), being less concerned about the harmful effects of smoking to themselves (OR = 1.6, CI = 0.9-2.8), viewing quit as temporary (OR = 2.1, CI = 1.2-3.6), and self-identifying selves as smokers (OR = 8.7, CI = 5.0-15.2). CONCLUSIONS: Although some factors related to intention to return to smoking were unchangeable, it might be possible to attempt to change women's attribution of why they quit to be more permanent and to have them change their self-identity to be a "nonsmoker" from a "smoker who is not currently smoking." Helping women have stronger intentions to stay quit could promote less return to smoking postpartum.

A pilot study testing SMS text delivered scheduled gradual reduction to pregnant smokers.

INTRODUCTION: Smoking during pregnancy causes multiple perinatal complications; yet, the smoking rate among pregnant women has remained relatively stagnant. Most interventions to help pregnant smokers quit or reduce their smoking are not easily disseminable. Innovative and disseminable interventions are needed. METHODS: We recruited 31 pregnant smokers in their second trimester from prenatal clinics. We assessed feasibility, acceptability, and preliminary efficacy of an SMS text-based intervention in a 2-arm design. We compared SMS-delivered support messages to an intervention that provided support messages plus a scheduled gradual reduction (SGR) to help women reduce their smoking more than 3 weeks. We sent women in the SGR arm "alert texts" at times to instruct them to smoke. We asked women not to smoke unless they received an alert text. RESULTS: Most women (86%) reported reading most or all of the texts. Women in both arms rated the program as helpful (M = 6, SD = 1 vs. M = 5, SD = 2, SGR vs. support only, respectively). Women in the SGR arm had a higher rate of biochemically validated 7-day point prevalence at the end of pregnancy 13.4% versus 7.5%. Of those still smoking, women reduced their smoking substantially with more reduction in the SGR arm (SGR arm: M = 16, SD = 11 vs. support messages only: M = 12, SD = 7). CONCLUSIONS: We developed an easily disseminable intervention that could possibly promote cessation and reduction among pregnant women with SMS texting ability. Women in this pilot were enthusiastic about the program, particularly those in the SGR arm. This program needs further examination.

Can physicians accurately predict which patients will lose weight, improve nutrition and increase physical activity?

BACKGROUND: Physician counselling may help patients increase physical activity, improve nutrition and lose weight. However, physicians have low outcome expectations that patients will change. The aims are to describe the accuracy of physicians' outcome expectations about whether patients will follow weight loss, nutrition and physical activity recommendations. The relationships between physician outcome expectations and patient motivation and confidence also are assessed. METHODS: This was an observational study that audio recorded encounters between 40 primary care physicians and 461 of their overweight or obese patients. We surveyed physicians to assess outcome expectations that patients will lose weight, improve nutrition and increase physical activity after counselling. We assessed actual patient change in behaviours from baseline to 3 months after the encounter and changes in motivation and confidence from baseline to immediately post-encounter. RESULTS: Right after the visit, ~55% of the time physicians were optimistic that their individual patients would improve. Physicians were not very accurate about which patients actually would improve weight, nutrition and physical activity. More patients had higher confidence to lose weight when physicians thought that patients would be likely to follow their weight loss recommendations. CONCLUSIONS: Physicians are moderately optimistic that patients will follow their weight loss, nutrition and physical activity recommendations. Patients might perceive physicians' confidence in them and thus feel more confident themselves. Physicians, however, are not very accurate in predicting which patients will or will not change behaviours. Their optimism, although helpful for patient confidence, might make physicians less receptive to learning effective counselling techniques.

Triadic agreement about advanced cancer treatment decisions: Perceptions among patients, families, and oncologists.

OBJECTIVES: When patients make cancer treatment decisions, they consider the needs and preferences of family caregivers and clinicians. We examined how much all three triad members agreed about goals of treatment and caregivers' influence on decision-making. METHODS: We surveyed 70 triads of patients, caregivers, and oncologists who had recently made an advanced cancer treatment decision. We assessed each triad member's perception of the goal of treatment and the caregiver's influence on the decision. Participants also completed scales related to decisional conflict, satisfaction, and regret. RESULTS: In only 28/70 triads (40%), all three agreed on the goal of treatment with the most common goal being to live longer (n = 22). Whereas patients and caregivers tended to think the goal was to cure or live longer, oncologists were less optimistic. In only 22 triads (31%), all three agreed on how much influence the caregiver had on decision-making. Oncologists tended to underestimate caregiver influence. Patients and caregivers had low decisional conflict (M=15.40, SD=4.51; M=17.09, SD=6.34, respectively). CONCLUSIONS: Advanced cancer treatment decision-making occurs amid incomplete understanding among patients, caregivers, and oncologists. PRACTICE IMPLICATIONS: Confirming agreement about goals of care and influence on treatment decision-making may increase the likelihood of goal-concordant care throughout the illness trajectory.

Is pregnancy a teachable moment for smoking cessation among US Latino expectant fathers? A pilot study.

OBJECTIVE: Pregnancy may be a time when US Latino expectant fathers consider quitting smoking. A 'teachable moment' is theorized to increase motivation to change a behavior through increased risk perceptions, emotional responses, and changes in self-image. DESIGN: We recruited 30 Spanish-speaking expectant fathers through their pregnant partners. We assessed expectant fathers' diet, exercise, and smoking and teachable moment constructs (risk perceptions, emotional responses, and self-image).We also tested correlations between teachable moment constructs and motivation to change behaviors. RESULTS: Latino expectant fathers had high-risk perceptions that their smoking harmed the pregnancy (M=4.4, SD=0.5 on five-point scale) and strong emotional responses about their smoking during pregnancy (M=3.9, SD=1.1). They also felt it was their role to make the pregnancy healthy (M=4.4, SD=0.8). They felt less strongly that their diet and exercise affected the pregnancy. The teachable moment constructs for smoking were strongly correlated with motivation to quit smoking; the same was not true for diet and exercise. CONCLUSIONS: Latino expectant fathers seem aware that their smoking could harm the pregnancy but seem less concerned about the effect of their diet and exercise on the pregnancy. Pregnancy may be a time to help Latino expectant fathers quit smoking.

The Co-occurrence of Daily Smoking, Binge Drinking and IPV Among Latino Expectant Fathers.

Many Latino men have multiple risk factors that predispose them to chronic disease morbidity and mortality, yet few have examined patterns in this population. We describe the co-occurrence of daily smoking, binge drinking, and intimate partner violence (IPV) behaviors among Latino expectant fathers and examine factors associated with the co-occurrence of these behaviors. We conducted a secondary analysis of baseline data from the Parejas Trial, a randomized controlled trial testing a culturally tailored couples-based smoking cessation intervention. We used Kruskal-Wallis test statistics to explore the relationship of the co-occurring behavior and demographic and cultural factors. All participants smoked as was a requirement of being in the trial, but only 39% smoked daily. Forty three percent of the participants engaged in one behavior, 32% engaged in two behaviors, and 5% engaged in three behaviors, with binge drinking being the most common co-occurring behavior. In the bivariate analysis, higher stress (p = 0.01) and having more children (p = 0.003) were found to be positively significantly associated with the number of behaviors. Helping Latino expectant fathers manage with their stress may serve as tailoring points for future interventions to reduce risk behaviors.

Adherence to nicotine replacement therapy among pregnant smokers.

INTRODUCTION: This secondary analysis examined the association between adherence to nicotine replacement therapy (NRT) and smoking cessation among pregnant smokers enrolled in Baby Steps, an open-label randomized controlled trial testing cognitive-behavioral therapy (CBT) versus CBT plus NRT. METHOD: The analysis included only women who received NRT for whom we had complete data (N = 104). Data came from daily calendars created from recordings of counseling sessions and from telephone surveys at baseline and 38 weeks gestation. RESULTS: Overall, 29% of the 104 women used NRT for the recommended 6 weeks and 41% used NRT as directed in the first 48 hr after a quit attempt. Ordinal logistic regression modeling indicated that using NRT as directed in the first 48 hr and having made a previous quit attempt were the strongest predictors of longer NRT use. Univariate analyses suggested that primigravid women and women who used NRT longer were more likely to report quitting at 38 weeks gestation. DISCUSSION: Findings indicated that adherence to NRT is low among pregnant smokers, but adherence was a predictor of cessation. Future trials should emphasize adherence, particularly more days on NRT, to promote cessation during pregnancy.

Pilot randomized trial of a couple-based physical activity videoconference intervention for sedentary cancer survivors.

OBJECTIVE: Including partners in interventions to increase physical activity (PA) could promote better adherence and longer-term effects. In preparation for a future large-scale randomized controlled trial (RCT), this randomized pilot trial tested the acceptability of a novel couple-based PA intervention for breast and prostate cancer survivors and the feasibility of conducting an RCT testing the intervention. METHOD: Twenty cancer survivors (70% female; mean age = 63.0 years, SD = 8.9) and their partners (35% female; mean age = 62.8 years, SD = 7.7) were randomized to either the intervention or waitlist control. Couples in the intervention received four videoconference sessions including training in communication and support skills and behavior change techniques. Measures of PA and partner support for exercise were collected from survivors and partners before randomization and postintervention. Survivors also completed a physical well-being measure, and intervention participants completed a treatment acceptability measure. RESULTS: Recruitment was challenging; approximately 18% of eligible survivors and their partners agreed to participate. Ninety-two percent of randomized participants completed postintervention surveys, and 78% of dyads randomized to the intervention arm completed all 4 sessions. Mean acceptability ratings were moderate to high. Mean difference scores suggested that participants in the intervention arm tended to report greater improvements in PA, partner support, and physical well-being than those in the control arm. CONCLUSIONS: These preliminary findings suggest that the couple-based PA intervention was acceptable to survivors and their partners and that a large-scale RCT is likely to be feasible with modified recruitment strategies. Recommendations for improving recruitment and conducting a larger study are presented. (PsycINFO Database Record

A smoking cessation and pain management program for cancer survivors.

PURPOSE: Many cancer survivors continue to smoke. Further, most survivors also report high levels of persistent pain and smoke in response to pain. The investigators tested the feasibility, acceptability, and preliminary efficacy of a smoking cessation program paired with a pain management program for cancer survivors. METHODS: The investigators conducted a two-arm, wait-list randomized controlled pilot study in which they delivered a combined smoking cessation and pain management intervention. RESULTS: The investigators randomized 30 survivors (14 intervention and 16 wait-list control). Seventy-one percent of the survivors who received the intervention rated it as extremely useful (5 out of 5) in helping them quit smoking. Further, 86% would recommend the program to other survivors. Although we could not conduct inferential statistics, 14% of those in the intervention arm, compared to 6% in the control condition had biochemically validated cessation at 2-months post-randomization. Survivors in the intervention also reported less pain, had improvements in depressive symptoms, and better physical function than those in the control arm. CONCLUSIONS: Our pilot data suggest the feasibility, acceptability, and preliminary efficacy of this approach. The next step is to conduct a large randomized controlled trial to fully test the efficacy of the intervention. IMPLICATIONS FOR CANCER SURVIVORS: A combined smoking cessation and pain program might help improve both issues simultaneously.

Accuracy and congruence of physician and adolescent patient weight-related discussions: Teen CHAT (Communicating health: Analyzing talk).

OBJECTIVE: We assessed the accuracy and congruence of recall of weight topics during clinical encounters between adolescent patients with overweight/obesity and physicians (randomized to Motivational Interviewing education vs. control arm). METHODS: We audio recorded 357 clinic encounters and coded topics of weight, physical activity (PA), breakfast, and fast food. We assessed recall accuracy/congruence. Generalized estimation equation modeling assessed associations between selected factors and recall accuracy. RESULTS: Accuracy for physicians was: weight (90%), PA (88%), breakfast (77%) and fast food (70%). Patient accuracy was: weight (94%), PA (94%), breakfast (73%) and fast food (61%). Physician/patient congruence was: weight (89%), PA (90%), breakfast (71%) and fast food (67%). Use of a reminder report indicating adolescent's weight behaviors in the physician control group resulted in increased adolescent (p = 0.02) and physician accuracy (p = 0.05) for fast food. Adolescents were more likely to recall discussions of fast food (odds ratio, 0.87; 95% CI, 0.77-0.97) as encounter time decreased; male adolescents were less likely to recall breakfast than females (odds ratio, 0.52; 95% CI, 0.28-0.95). CONCLUSION: Adolescents and physicians recall weight and PA more often, perhaps indicating greater engagement in these topics. PRACTICE IMPLICATIONS: Reminder reports might possibly enhance discussion and recall of diet related messages.

Physician Weight-Related Counseling Is Unrelated to Extreme Weight Loss Behaviors Among Overweight and Obese Adolescents.

Some physicians may be hesitant to counsel overweight and obese adolescents about weight because of concerns that such counseling may result in extreme weight loss behaviors and the subsequent development of eating disorders. We compared self-reported extreme weight loss behaviors in 535 overweight/obese adolescents prior to receiving weight-related counseling during primary care visits, and again after 3 months. We found no change in fasting (7.7% vs 6.3%, P = .45), and decreases in diet pill use (4.1% vs 1.7%, P = .003) and laxative use/vomiting (2.6% vs 1.0%, P = .02). Three months following their medical appointment, patients were also less likely to report trying to lose weight in general (80.0% vs 75.6%, P = .04). Physicians should be reassured that providing weight-related counseling to their obese adolescents is unlikely to induce extreme weight loss behaviors. Frequent counseling may be required in order to help patients maintain motivation to attain a healthy weight.

Nicotine replacement and behavioral therapy for smoking cessation in pregnancy.

BACKGROUND: This study examines whether adding nicotine replacement therapy (NRT) to cognitive-behavioral therapy (CBT) for pregnant smokers increases rates of smoking cessation. METHODS: An open-label randomized trial (Baby Steps, n=181) of CBT-only versus CBT+NRT (choice of patch, gum, or lozenge; 1:2 randomization) was used. Data were collected from 2003 through 2005; analyses were conducted in 2006 and 2007. Outcomes were biochemically validated self-reported smoking status at 7 weeks post-randomization, 38 weeks gestation, and 3 months postpartum. RESULTS: Women in the CBT+NRT arm were almost three times more likely than women in the CBT-only arm to have biochemically validated cessation at both pregnancy time points (after 7 weeks: 24% vs 8%, p=0.02; at 38 weeks gestation: 18% vs 7%, p=0.04), but not at 3 months postpartum (20% vs 14%, p=0.55). Recruitment was suspended early by an Independent Data and Safety Monitoring Board when an interim analysis found a higher rate of negative birth outcomes in the CBT+NRT arm than in the CBT-only arm. In the final analysis, the difference between the arms in rate of negative birth outcomes was 0.09 (p=0.26), when adjusted for previous history of preterm birth. CONCLUSIONS: The addition of NRT to CBT promoted smoking cessation in pregnant women. This effect did not persist postpartum. More data are needed to determine safety parameters and to confirm the efficacy of NRT use during pregnancy.

Use of the 5 As for Teen Alcohol Use.

Clinical guidelines recommend addressing adolescent alcohol use in primary care; the 5 As (Ask, Advise, Assess, Assist, Arrange) may be a useful model for intervention. We audio-recorded 540 visits with 49 physicians and adolescents, compared alcohol disclosure rates in the encounter with those in a survey, and analyzed conversations for use of the 5 As and their relation to adolescent reports of drinking 3 months after the encounter. When physicians asked clear, nonleading questions, drinkers were more likely to disclose alcohol use ( P = .004). In 64% of visits in which alcohol was discussed, physicians used one or more of the 5 As, most frequently "Ask." No physician used all 5 As. Among drinkers, there was no association between physicians' partial use of the 5 As and adolescent alcohol consumption at 3 months. Physicians can learn more effective ways to "Ask" about alcohol use to increase disclosure of drinking and to be more comprehensive in their counseling.