Feasibility of yoga as a complementary therapy for patients with type 2 diabetes: The Healthy Active and in Control (HA1C) study.

OBJECTIVES: This study:Healthy Active and in Control (HA1C), examined the feasibility and acceptability of yoga as a complementary therapy for adults with Type-2 Diabetes (T2DM). DESIGN: A 2-arm randomized clinical trial comparing Iyengar yoga with a supervised walking program. SETTING: Hospital based gym-type facility and conference rooms. INTERVENTIONS: Participants were randomized to a 12-week program of either; (1) a twice weekly Iyengar yoga, or (2) a twice-weekly program of standard exercise (SE). MAIN OUTCOME MEASURES: Primary outcomes assessed feasibility and acceptability, including enrollment rates, attendance, study completion, and participant satisfaction. Secondary outcomes included HbA1c, physical activity, and measures of diabetes-related emotional distress, self-care and quality of life (QOL). Assessments were conducted at baseline, end of treatment, 6-months and 9-months post-enrollment. RESULTS: Of 175 adults screened for eligibility, 48 (30 women, 18 men) were eligible and enrolled. The most common reasons for ineligibility were orthopedic restrictions, HbA1c levels <6.5 and BMI > 42. Session attendance was high (82% of sessions attended), as was follow-up completion rates (92%). Program satisfaction rated on a 5-point scale, was high among both Yoga (M = 4.63, SD = 0.57) and SE (M = 4.77, SD = 0.52) participants. Overall 44 adverse events (26 Yoga, 18 SE) were reported. Of these, six were deemed "possibly related" (e.g., neck strain, back pain), and 1 "probably related" (ankle pain after treadmill) to the study. Yoga produced significant reductions in HbA1c. Median HbA1c at 6 months was 1.25 units lower for Yoga compared to SE (95% CI: -2.54 -0.04). Greater improvements in diabetes self-care, quality of life, and emotional distress were seen among Yoga participants than among SE participants. Increases in mindfulness were seen in Yoga but not in SE. CONCLUSIONS: The yoga intervention was highly feasible and acceptable, and produced improvements in blood glucose and psychosocial measures of diabetes management.

Sleep duration and weight loss among overweight/obese women enrolled in a behavioral weight loss program.

OBJECTIVE: The purpose of this study was to examine whether baseline sleep duration predicts weight loss outcomes in a randomized controlled trial examining a behavioral weight loss (BWL) intervention among overweight and obese (OW/OB) women with urinary incontinence; and whether participation in the BWL intervention is associated with changes in sleep duration. DESIGN: Longitudinal, clinical intervention study of a 6-month BWL program. SUBJECTS: Three hundred sixteen OW/OB women, with urinary incontinence (age: 30-81 years, body mass index (BMI; 25-50 kg m(-2)) enrolled from July 2004-April 2006. MEASUREMENTS: Measured height and weight, self-report measures of demographics, sleep and physical activity. RESULTS: Neither self-reported total sleep time (TST) nor time in bed (TIB) at baseline significantly predicted weight loss outcomes among OW/OB women in a BWL treatment. BWL treatment was successful regardless of how much subjects reported sleeping at baseline, with an average weight loss of 8.19 kg for OW/OB women receiving BWL treatment, versus a weight loss of 1.44 kg in the control condition. Similarly, changes in weight, BMI and incontinence episodes did not significantly predict changes in sleep duration or TIB across the treatment period. CONCLUSION: Although epidemiological and cross-sectional studies support a relationship between short sleep and increased BMI, the present study found no significant relationship between TST or TIB and weight loss for OW/OB women participating in a BWL treatment.

Weight loss treatment influences untreated spouses and the home environment: evidence of a ripple effect.

OBJECTIVES: To examine whether a weight loss program delivered to one spouse has beneficial effects on the untreated spouse and the home environment. METHODS: We assessed untreated spouses of participants in three sites of Look AHEAD, a multicenter randomized controlled trial evaluating the impact of intentional weight loss on cardiovascular outcomes in overweight individuals with type 2 diabetes. Participants and spouses (n=357 pairs) were weighed and completed measures of diet and physical activity at 0 and 12 months. Spouses completed household food and exercise environment inventories. We examined differences between spouses of participants assigned to the intensive lifestyle intervention (ILI) or to the enhanced usual care (DSE; diabetes support and education). RESULTS: Spouses of ILI participants lost -2.2+/-4.5 kg vs -0.2+/-3.3 kg in spouses of DSE participants (P<0.001). In addition, more ILI spouses lost > or =5% of their body weight than DSE spouses (26 vs 9%, P<0.001). Spouses of ILI participants also had greater reductions in reported energy intake (P=0.007) and percent of energy from fat (P=0.012) than DSE spouses. Spouse weight loss was associated with participant weight loss (P<0.001) and decreases in high-fat foods in the home (P=0.05). CONCLUSION: The reach of behavioral weight loss treatment can extend to a spouse, suggesting that social networks can be utilized to promote the spread of weight loss, thus creating a ripple effect.

A randomized trial to reduce passive smoke exposure in low-income households with young children.

OBJECTIVE: Passive smoke exposure among children is widespread in the United States; estimates suggest that almost 40% of children who are younger than 5 years live with a smoker. Few randomized studies of passive smoke exposure reduction among children have been conducted, and the impact of interventions that have been evaluated has been limited. The objective of this study was to determine whether a motivational intervention for smoking parents of young children will lead to reduced household passive smoke exposure. METHODS: Project KISS (Keeping Infants Safe From Smoke), a theory-driven exposure reduction intervention targeting low-income families with young children, was a randomized controlled study in which participants-smoking parents/caregivers (N = 291) who had children who were younger than 3 years and who were recruited through primary care settings-were randomly assigned to either the motivational intervention (MI) or a self-help (SH) comparison condition was used. Follow-up assessments were conducted at 3 and 6 months. The MI condition consisted of a 30- to 45-minute motivational interviewing session at the participant's home with a trained health educator and 4 follow-up telephone counseling calls. Feedback from baseline household air nicotine assessments and assessment of the participant's carbon monoxide level was provided as part of the intervention. Participants in the SH group received a copy of the smoking cessation manual, the passive smoke reduction tip sheet, and the resource guide in the mail. Household nicotine levels were measured by a passive diffusion monitor. RESULTS: The 6-month nicotine levels were significantly lower in MI households. Repeated measures analysis of variance across baseline, 3-month, and 6-month time points showed a significant time-by-treatment interaction, whereby nicotine levels for the MI group decreased significantly and nicotine levels for the SH group increased but were not significantly different from baseline. CONCLUSIONS: This study targeted a large sample of racially and ethnically diverse low-income families, in whom both exposure and disease burden is likely to be significant. This is the first study to our knowledge that has been effective in reducing objective measures of passive smoke exposure in households with healthy children. These findings have important implications for pediatric health care providers, who play an important role in working with parents to protect children's health. Providers can help parents work toward reducing household passive smoke exposure using motivational strategies and providing a menu of approaches regardless of whether the parents are ready to quit.

Evaluating a population-based recruitment approach and a stage-based expert system intervention for smoking cessation.

A stage-matched expert system intervention was evaluated on 4144 smokers in a two-arm randomized control trial with four follow-ups over 24 months. Smokers were recruited by random digit-dial calls, and 80.0% of the eligible smokers were enrolled. Individualized and interactive expert system computer reports were sent at 0, 3, and 6 months. The reports provided feedback on 15 variables relevant for progressing through the stages. The primary outcomes were point prevalence and prolonged abstinence rates. At 24 months, the expert system resulted in 25.6% point prevalence and 12% prolonged abstinence, which were 30% and 56% greater than the control condition. Abstinence rates at each 6-month follow-up were significantly greater in the Expert System (ES) condition than in the comparison condition with the absolute difference increasing at each follow-up. A proactive home-based stage-matched expert system smoking cessation program can produce both high participation rates and relatively high abstinence rates.

Intervention and policy issues related to children's exposure to environmental tobacco smoke.

BACKGROUND: Children's exposure to environmental tobacco smoke (ETS) is unacceptably high; almost 40% of children in the United States are regularly exposed to ETS. METHODS: This paper presents a review of the literature that evaluates interventions designed to reduce ETS exposure among young children. In addition, it presents the study design for Project KISS (Keeping Infants Safe from Smoke), an intervention designed to utilize exposure-related feedback to increase parents' motivation for ETS reduction and to reduce household ETS levels. Baseline data are presented to illustrate factors that should be addressed in ETS interventions. RESULTS: The literature review demonstrates the dearth of studies in the literature targeting ETS reduction among children. Participants in Project KISS believed that smoking had affected their children's health and were in later stages of motivational readiness to quit smoking than is typically observed. However, they face a number of challenges to smoking, such as high prevalence of nicotine dependence, high prevalence of living with other smokers, and socioeconomic and stress-related barriers. CONCLUSIONS: The policy implications of this research are discussed, and recommendations are made for future research.

Counselor and stimulus control enhancements of a stage-matched expert system intervention for smokers in a managed care setting.

BACKGROUND: Previous research has demonstrated the efficacy of an interactive expert system intervention for smoking cessation for a general population. The intervention provides individualized feedback that guides participants through the stages of change for cessation. Enhancing the expert system by adding proactive telephone counseling or a stimulus control computer designed to produce nicotine fading could produce preventive programs with greater population impacts. METHODS: Four interventions were compared: (a) the interactive expert system intervention; (b) the expert system intervention plus counselor calls; (c) the expert system intervention plus the stimulus control computer; and (d) an assessment only condition. A 4 (intervention) x 4 (occasions) (0,6,12, and 18 months) design was used. Smokers were contacted at home via telephone or mail. The initial subject pool was the 24,178 members of a managed care company. Screening was completed for 19,236 members (79.6%), of whom 4,653 were smokers; 85.3% of the smokers were enrolled. RESULTS: Thirty-eight percent were in the precontemplation stage, 45% in the contemplation stage, and only 17% in the preparation stage. At 18 months, the expert system resulted in 23.2% point prevalence abstinence, which was 33% greater than that of assessment only. The counselor enhancement produced increased cessation at 12 months but not at 18 months. The stimulus control computer produced no improvement, resulting in 20% worse cessation rates than the assessment only condition. CONCLUSIONS: The enhanced conditions failed to outperform the expert system alone. The study also demonstrated the ability of the interactive expert system to produce significantly greater cessation in a population of smokers than assessment alone.

Cluster subtypes within stage of change in a representative sample of smokers.

In this paper a three-level conceptualization of approaches to matching self-help behavior change strategies to individuals is presented based on the Transtheoretical Model of Change. Two of the model's intervention approaches, tailoring to Stage-of-Change and creating completely individualized interventions, have already been developed and implemented in previous research. A third intervention approach, in between stage-tailored and individualized, is targeting subtype groups within each Stage of Change. The subtype targeted intervention approach is in the initial development stage of empirically determining and validating the stage subtypes. Three studies are presented which investigate stage subtypes within a representative sample of 4,144 smokers in the Precontemplation, Contemplation, and Preparation Stages of Change. Within each Stage-of-Change study, two cluster analyses were performed using the Pros, Cons, and Situational Temptations from the Transtheoretical Model to establish cluster replicability. Cluster solutions were externally validated using the 10 Processes of Change and 2 smoking behavior variables. Four distinct subtypes were found in Precontemplation and Contemplation, and five subtypes were found in Preparation. These subtypes closely replicate subtypes previously found in a convenience sample of smokers and provide strong evidence for the existence of subtypes within the first three Stages of Change.

The transtheoretical model of smoking: comparison of pregnant and nonpregnant smokers.

Pregnant smokers represent a special population of women smokers. Since smoking affects both the mother and the unborn child, it might be hypothesized that pregnant women should be highly motivated to quit smoking during pregnancy. Results from both naturalistic studies and intervention studies have generally shown only modest changes in smoking during pregnancy. To help design more effective interventions tailored for this special population of smokers, more information is needed on how they differ from other smokers. The current study was designed to examine patterns and differences on constructs of the Transtheoretical Model between low-income culturally diverse pregnant and nonpregnant female smokers. Groups were compared on the distribution of the stages of change. In addition, stage and group comparisons were conducted for the pros and cons of smoking, situational temptations to smoke, and the processes of change. The sample included 103 economically disadvantaged, culturally diverse pregnant women and a matched group of 103 nonpregnant women smokers. Pregnant smokers as a group were similar to their nonpregnant peers on their readiness for quitting. In general, the patterns observed across the stages of change were consistent with those seen in other populations of smokers. The primary difference found between the groups were on the cons of smoking, habit-related temptations to smoke, and experiential processes of change. Specifically, pregnant women perceived a less negative attitude toward their smoking, were more tempted in habit-related situations, and made less use of important experiential processes of change. The implications of these findings for designing interventions tailored for this special group of smokers are discussed.

The Transtheoretical Model and stress management practices in women at risk for, or infected with, HIV.

Although scientific inquiry using the Transtheoretical Model of Behavior (TTM) supports various behavior changes in multiple samples, no research was found that examined this model with women already infected with HIV. This article provides a brief overview of the related literature and describes a pilot study that evaluated TTM concepts in women at risk for, or infected with, HIV. The pilot study examined preliminary psychometrics of the research measures in women at risk for (n = 9), or infected with, HIV (n = 10), and examined predicted differences in situational confidence and stress management practices by HIV serostatus (positive vs. negative) and stage of change (precontemplation and contemplation vs. preparation, action, and maintenance) implied by the TTM. This pilot study supports use of the TTM to examine readiness to use stress management behavior in women regardless of their HIV serostatus. Further TTM stress management inquiry is encouraged to extend the knowledge base needed in caring for this vulnerable population.

Measuring participatory strategies: instrument development for worksite populations.

A participatory strategies approach which involves employees in the planning and delivery of worksite health promotion programs was utilized in the 55 experimental worksites included in the national, NCI-funded Working Well Trial. According to study protocol, Employee Advisory Boards (EABs) were organized in each experimental worksite. This paper describes two substudies designed to develop and measure participatory strategies associated with the EABs in the Working Well Trial. Study 1 determined characteristics of the EABs, developed subscales and assessed the internal consistency of the scales. Study 2 used a confirmatory factor analysis to examine the structure of the developed questionnaire. The four subscales include: Autonomy/Independence, Management Involvement, Institutionalization/Commitment and Others Involvement. Results from Study 1 indicate that the four subscales of the 24-item instrument demonstrated strong internal consistency and three were sensitive enough to register differences by Study Center at the baseline. Study 2 results found that the EAB subscales again demonstrated good internal consistency, structural stability and acceptable sensitivity. An initial validity analysis was performed and yielded results which supported some but not all of the hypothesized associations. Implications for further refinement and application of this new instrument in worksite settings are explored.

Testing 40 predictions from the transtheoretical model.

Sensitive measurement of behavior change requires dependent measures that are sensitive to the whole spectrum of change, not just a single aspect of change. Traditional outcome variables such as point prevalence for smoking cessation focus on a single discrete event and ignore all other progress. Alternatively, the criterion measurement model (CMM) is an approach that posits a three-construct outcome model (habit strength, positive evaluation strength, and negative evaluation strength), where different constructs are sensitive to change for different aspects of the temporal domain. In this article, a series of 40 differential a priori predictions were tested using a large representative sample of smokers. The focus was on the prediction of specific effect sizes rather than statistical significance. A series of comparisons involving stage transitions was examined using five variables representing the three CMM constructs. The predictions involved movement from one of three initial stages (precontemplation, contemplation, and preparation) to stage membership 12 months later. Thirty-six of the 40 predictions were confirmed, indicating that the outcome model has strong construct validity and accurately reflects movement between the stages of change.

Interactive versus noninteractive interventions and dose-response relationships for stage-matched smoking cessation programs in a managed care setting.

This study compared interactive and noninteractive smoking cessation interventions for a population of smokers who were all members of 1 division of a managed care company. In addition, it examined whether a dose-response relationship existed. Screening was completed for 19,236 members who were contacted by telephone or mail. Of the 4,653 who were identified as smokers, 85.3% were enrolled. A 2 Intervention (interactive or noninteractive) x 4 Contacts (1, 2, 3, or 6 contacts) x 4 Occasions (0, 6, 12, and 18 months) design was used. The interactive intervention was stage-matched expert-system reports plus manuals; the noninteractive intervention was stage-matched manuals. Contact occurred in 1 of 4 series (1, 2, 3 or 6 contacts) at 3-month intervals. The expert system outperformed the stage-matched manuals, but there was no clear dose-response relationship for either intervention.

Measuring support for tobacco control policy in selected areas of six countries.

OBJECTIVE: To explore the validity, reliability, and applicability of using a short, psychometrically sound survey instrument to measure population attitudes toward tobacco control policies. DESIGN: Surveys. SUBJECTS AND SETTING: Student respondents attending university in Australia (n = 403), Hong Kong (n = 336), the Netherlands (n = 351), South Africa (n = 291), the United Kingdom (n = 164) and the United States (n = 241); total n = 1786. MAIN OUTCOME MEASURE: The Smoking Policy Inventory (SPI), a 35-item scale. SPI scores were adjusted for age, income, gender, and smoking status. Estimates of internal consistency and tests of factorial invariance were conducted in each sample. RESULTS: Across all six countries, the SPI was found to be highly reliable and to have a consistent factor structure, indicating that the SPI scale represents a higher order construct that assesses general attitudes about tobacco control policy with five dimensions. In general, the degree of endorsement of anti-tobacco policies as measured by the SPI reflected the extent and strength of tobacco control legislation in those countries. Dutch students were the least likely, and Australian and Hong Kong students the most likely, to support tobacco control policies. CONCLUSIONS: It is possible to develop appropriate and meaningful measurement tools for assessing support of tobacco control policies. Strong evidence was found for internal reliability and structural invariance of the SPI. The SPI may be a useful mechanism for monitoring ongoing policy initiatives, making cross-cultural comparisons, and evaluating population receptiveness to proposed policy approaches.

Dynamic typology clustering within the stages of change for smoking cessation.

Dynamic typology clustering was employed to find homogeneous subgroups of smokers within each of three early stages of change (precontemplation, contemplation, preparation) in a representative sample of smokers. Individual change profiles were created by coding the stage of change for each subject at five consecutive assessment points over a 2-year period (baseline and 6, 12, 18, and 24 months). A total of 446 unique change profiles were found in the sample of 2,088 smokers who had complete data for all five time points. The sample was initially split into three groups determined by baseline stage of change. Within each initial stage, subgroups that shared similar patterns of change were interpreted by examining the shape and elevation of the change profiles. Four major types of profiles emerged: a stable profile, a progressing profile, a vacillating profile, and a regressing profile. External validation revealed significant differences among the dynamic typology subtypes on key transtheoretical model constructs (processes of change, decisional balance, situational temptations). These results both support and complement key construct relationships within the transtheoretical model and can provide important predictive information to direct and enhance treatment interventions for smoking cessation.

The development and structural confirmation of the Rhode Island Stress and Coping Inventory.

A new measure, the Rhode Island Stress and Coping Inventory (RISCI), was developed to examine perceived stress and coping independent of specific stress situations. An adult sample (N = 466) was randomly divided into equal halves for developmental and confirmatory instrument development. Initial instrument development used principal components analysis, item analysis, and a measure of internal consistency (Coefficient alpha). Confirmatory factor analysis (CFA) was employed on the confirmatory sample to examine the structure of the refined item set. Several CFA fit indices indicated excellent fit for a model that represents perceived stress and coping as two moderately correlated dimensions. Validity analyses found strong relationships in the expected directions for both RISCI subscales with the 5-item Mental Health Inventory. Further validity analyses supported the utility of the RISCI in applied research with smokers and confirmed past research findings that successful quitters experience less perceived stress and cope better than relapsers.

Esophageal schistosomiasis in a patient with megaesophagus.

The authors report a case of schistosomiasis of uncommon location. A patient submitted to esophagectomy for Chagas' megaesophagus was found to have eggs of Schistosoma mansoni upon pathologic examination of the surgical specimen. The authors discuss the anatomopathological aspects of schistosomiasis, as well as its occurrence in other rare sites. To date, no references in literature have been found on the existence of esophageal schistosomiasis, and its association to Chagas' megaesophagus has never been described.

Latent transition analysis to the stages of change for smoking cessation.

A key construct of the Transtheoretical Model of Behavior Change is the stage of change (Precontemplation, Contemplation, Preparation, Action, and Maintenance) (Prochaska & DiClemente, 1983, 1986). This study applies Latent Transition Analysis (LTA; Collins & Wugalter, 1992; Collins, Wugalter, & Rousculp, 1991) to movement through the stages of change for smoking cessation. LTA is an alternative method of assessing categorical outcome that is sensitive to change, diagnostic, and allows for the comparison of alternative models of change. The sample consisted of 545 reactively recruited smokers and former smokers who were assessed five times over a two year period. LTA was used to compare three specified models. The model that fit the data best indicates that in a six month time frame both progression and regression among the stages takes place as well as two stage progression. Examination of the probability of movement among the stages revealed three findings consistent with the Transtheoretical Model. First, movement through the stages is not always linear. Second, the probability of forward movement was greater than backward movement. Third, the probability of moving to adjacent stages was greater than the probability of two stage progression.

Measuring nicotine dependence among high-risk adolescent smokers.

In the present study we tested our hypothesis that because of the higher prevalence and greater intensity of cigarette smoking among vocational-technical students (N = 110; 51.8% males; mean age 17 years), adolescents might demonstrate the nicotine dependence patterns comparable to those measured in a similar fashion in a group of adult smokers (N = 173; 50% males; mean age 42 years). A modified version of the Fagerström Tolerance Questionnaire (FTQ) utilized in the adolescent sample was coded to make it comparable to the original FTQ used in the adult sample. The tests of item structure and internal consistency of the modified FTQ for adolescents were satisfactory; the overall mean FTQ score correlated significantly with the intensity and duration of smoking. Although the FTQ values were generally lower in the adolescent sample, 20% of students had an overall FTQ score of 6 and above, indicating substantial nicotine dependence (compared to 49% in adults). Reasons for failure of the existing adolescent smoking cessation programs as well as the rationale for adding a nicotine replacement option to the behavioral smoking cessation treatment for a subset of high-risk nicotine-dependent adolescents are discussed.