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The prevalence of non-communicable diseases, such as diabetes and cardiovascular disease, is rising in low- and middle-income countries (LMICs). Health behavior change (HBC) interventions such as the widely used Diabetes Prevention Program (DPP) are effective at reducing chronic disease risk, but have not been adapted for LMICs. Leveraging mobile health (mHealth) technology such as text messaging (SMS) to enhance reach and participant engagement with these interventions has great promise, yet we lack evidence-informed approaches to guide the integration of SMS specifically to support HBC interventions in LMIC contexts. To address this gap, we integrated guidance from the mHealth literature with expertise and first-hand experience to establish specific development steps for building and implementing SMS systems to support HBC programming in LMICs. Specifically, we provide real-world examples of each development step by describing our experience in designing and delivering an SMS system to support a culturally-adapted DPP designed for delivery in South Africa. We outline eight key SMS development steps, including: 1) determining if SMS is appropriate; 2) developing system architecture and programming; 3) developing theory-based messages; 4) developing SMS technology; 5) addressing international SMS delivery; 6) testing; 7) system training and technical support; and 8) cost considerations. We discuss lessons learned and extractable principles that may be of use to other mHealth and HBC researchers working in similar LMIC contexts.Trial registration Clinicaltrials.gov, NCT03342274 . Registered 10 November 2017., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Although most cancers are sporadic, germline genetic variants are implicated in 5-10% of cancer cases. Clinical genetic testing identifies pathogenic germline genetic variants for hereditary cancers. The Michigan Genetic Hereditary Testing (MiGHT) study is a three-arm randomized clinical trial that aims to test the efficacy of two patient-level behavioral interventions on uptake of cancer genetic testing., Methods: The two interventions being tested are (1) a virtual genetics navigator and (2) motivational interviewing by genetic health coaches. Eligible participants are adults with a diagnosis of breast, prostate, endometrial, ovarian, colorectal, or pancreatic cancer who meet the National Comprehensive Cancer Network (NCCN) criteria for genetic testing. Participants are recruited through community oncology practices affiliated with the Michigan Oncology Quality Consortium (MOQC) and have used the Family Health History Tool (FHHT) to determine testing eligibility. The recruitment goal is 759 participants, who will be randomized to usual care or to either the virtual genetics navigator or the motivational interviewing intervention arms. The primary outcome will be the proportion of individuals who complete germline genetic testing within 6 months., Discussion: This study addresses patient-level factors which are associated with the uptake of genetic testing. The study will test two different intervention approaches, both of which can help address the shortage of genetic counselors and improve access to care., Trial Registration: This study has been approved by the Institutional Review Board of the University of Michigan Medical School (HUM00192898) and registered in ClinicalTrials.gov (NCT05162846)., (© 2023. The Author(s).)

Background: The concomitant use of anticoagulant and antiplatelet medications increases the risk of upper gastrointestinal (GI) bleeding. Two underused evidence-based practices (EBPs) can reduce the risk: de-prescribe unnecessary antiplatelet therapy or initiate a proton pump inhibitor. We describe the development of a multicomponent intervention to increase use of these EBPs in patients treated with warfarin and followed by an anticoagulation monitoring service (AMS), and the design of a pilot pragmatic implementation trial., Methods: A participatory planning group iteratively used Implementation Mapping and the Multiphase Optimization Strategy to develop implementation strategies and plan the trial. Informed by qualitative interviews with patients and clinicians, we drew on several implementation science theories, as well as self-determination theory, to design interventions. For patients, we developed an activation guide to help patients discuss the EBPs with their clinicians. For clinicians, we developed two electronic health record (EHR)-based interventions: (1) clinician notification (CN) consists of a templated message that identifies a patient as high risk, summarizes the EBPs, and links to a guidance statement on appropriate use of antiplatelet therapy. (2) Clinician notification with nurse facilitation (CN+NF) consists of a similar notification message but includes additional measures by nursing staff to support appropriate and timely decision-making: the nurse performs a chart review to identify any history of vascular disease, embeds indication-specific guidance on antiplatelet therapy in the message, and offers to assist with medication order entry and patient education. We will conduct a pilot factorial cluster- and individual-level randomized controlled trial with a primary objective of evaluating feasibility. Twelve clinicians will be randomized to receive either CN or CN+NF for all their patients managed by the AMS while 50 patients will be individually randomized to receive either the activation guide or usual care. We will explore implementation outcomes using patient and clinician interviews along with EHR review., Discussion: This pilot study will prepare us to conduct a larger optimization study to identify the most potent and resource conscious multicomponent implementation strategy to help AMSs increase the use of best practices for upper GI bleeding risk reduction., Trial Registration: ClinicalTrials.gov NCT05085405 . Registered on October 19, 2021-retrospectively registered., (© 2022. The Author(s).)

Background: About half of people with glaucoma do not adhere to their recommended medications. Interventions for other chronic conditions have successfully utilized reminder systems and motivational interviewing (MI)-based counseling. This study was designed to pilot a personalized intervention that leverages these strategies to assess their impact on medication adherence in glaucoma patients., Methods: Glaucoma patients taking ≥ 1 medication will be pre-screened by telephone survey for adherence to their medication(s). Those who self-report poor adherence will be enrolled in a 3-month monitoring period to measure medication adherence using electronic medication monitors. Participants who are non-adherent (take 

Background: African Americans suffer disproportionately from tobacco-related illness and have more difficulty quitting smoking than other racial/ethnic groups. Previous research indicates that African American treatment-seekers are high utilizers of tobacco quitlines, yet cessation rates via quitlines are lower relative to whites. The goal of the present study is to test the effectiveness of adding a culturally specific, video-based, adjunct to standard quitline care. It is hypothesized that the integration of an evidence-based intervention (Pathways to Freedom: Leading the Way to a Smoke-Free Community©; PTF) into quitline services will increase cessation and treatment engagement compared to control conditions, and that effects will be moderated by sociocultural factors (e.g., culturally specific intervention expectancies, acculturation, and ethnic identity)., Methods: This study is a 3-arm semi-pragmatic randomized controlled trial (RCT). Participants will be 1050 enrollees in the North Carolina State quitline (QuitlineNC) who self-identify as African American. Usual quitline care includes up to 4 proactive quit coaching calls, website access, and two-weeks of nicotine patch therapy. Eligible study participants will be randomized to receive (1) standard quitline services plus PTF (PTF); (2) quitline services plus a standard tobacco cessation DVD (attention control); or (3) quitline services alone (usual care). Assessments will be conducted at baseline, 3 and 6-months post-enrollment. The primary outcome will be biochemically verified 7 day ppa at 6-months. Generalized linear mixed models (GLMMs) and hierarchical logistic regression will be used to assess the effects of treatment group on cessation outcomes and to test potential moderators., Discussion: This study will answer questions regarding the implementation and effectiveness of integrating a culturally specific video intervention into a real-world, population-level tobacco intervention. It will also aid our understanding of individual-difference variables that are associated with success. If an incremental benefit is found, this trial will have implications for increasing the responsiveness of tobacco quitlines for African Americans, reducing tobacco cessation disparities, and best practices for improving minority health. In addition, the PTF intervention has the potential for widespread disseminated through quitlines, which are available across the United States., Trial Registration: Clinicaltrials.gov NCT03064971 . Registered on February 22, 2017.

Background: Understanding factors related to girls' body image discrepancy, which is the difference between self-perceived current or actual and ideal body size, is important for addressing body-related issues and preventing adverse sequelae. Two aims were to: 1) examine demographic differences in body image discrepancy; and 2) determine the association of body image discrepancy with weight status, percent body fat, physical activity, sedentary behavior, and cardiovascular (CV) fitness among young adolescent girls., Methods: The cross-sectional study included a secondary analysis of baseline data from a group randomized controlled trial including 1519 5th-8th grade girls in 24 U.S. schools. Girls completed physical activity and sedentary behavior surveys. To indicate perceived current/actual and ideal body image, girls selected from nine body figures the one that represented how they look now and another showing how they want to look. Girls wore accelerometers measuring physical activity. Height, weight, and percent body fat were assessed. The Progressive Aerobic CV Endurance Run was used to estimate CV fitness. Independent t-test, one- and two-way ANOVA, correlational analyses, and hierarchical linear regressions were performed., Results: The majority (67.5%; n = 1023) chose a smaller ideal than current/actual figure. White girls had higher body image discrepancy than Black girls (p = .035). Body image discrepancy increased with increasing weight status (F 3,1506  = 171.32, p < .001). Moderate-to-vigorous physical activity (MVPA) and vigorous physical activity were negatively correlated with body image discrepancy (r = -.10, p < .001; r = -.14, p < .001, respectively), but correlations were not significant after adjusting for race and body mass index (BMI), respectively. Body image discrepancy was moderately correlated with CV fitness (r = -.55, p < .001). After adjusting for demographics, percent body fat, but not CV fitness or MVPA, influenced body image discrepancy. Girls with higher percent body fat had higher body image discrepancy (p < .001)., Conclusion: This study provided important information to guide interventions for promoting a positive body image among girls., Trial Registration: ClinicalTrials.gov Identifier NCT01503333 , registration date: January 4, 2012.

Background: Rates of noncommunicable diseases (NCDs) such as type 2 diabetes are escalating in low and middle-income countries such as Brazil. Scalable primary care-based interventions are needed to improve self-management and clinical outcomes of adults with diabetes. This pilot study examines the feasibility, acceptability, and outcomes of training community health agents (CHAs) in Motivational Interviewing (MI)-based counseling for patients with poorly controlled diabetes in a primary care center in São Paulo, Brazil., Methods: Nineteen salaried CHAs participated in 32 h of training in MI and behavioral action planning. With support from booster training sessions, they used these skills in their regular monthly home visits over a 6 month period with 57 diabetes patients with baseline HbA1cs > 7.0%. The primary outcome was patients' reports of the quality of diabetes care as measured by the Portuguese version of the Patient Assessment of Chronic Illness Care (PACIC) scale. Secondary outcomes included changes in patients' reported diabetes self-management behaviors and in A1c, blood pressure, cholesterol and triglycerides. We also examined CHAs' fidelity to and experiences with the intervention., Results: Patients reported improvements over the 6 month period in quality of diabetes care received (PACIC score improved 33 (+/-19) to 68 (+/-21) (p < .001)). They reported increases in physical activity (p = .001), consumption of fruits and vegetables (p < .001) and medication adherence (p = .002), but no decreases in consumption of high-fat foods (p = .402) or sweets (p = .436). Participants had mean 6-month A1c levels 0.34% points lower than at baseline (p = .08) and improved mean LDL (-16.1 mg/dL, p = .005) and triglyceride levels (-38.725 mg/dL, p = .002). Of the 16 CHAs observed in fidelity assessments, 13 were categorized as medium- or high-performing on MI skills, while 3 were low-performing. CHAs expressed enthusiasm about learning new skills, and many described a shift from advice-giving to encouraging patients to define their own goals., Conclusion: In resource-scarce settings, it is essential to fully utilize existing primary care resources to stem the epidemic of diabetes and other NCDs. Our pilot results support the potential of training CHAs to incorporate effective diabetes self-management support into their routine patient encounters., Trial Registration: NCT02994095 12/14/2016 Registered retrospectively.

Background: The Health Care Climate Questionnaire measures patient perceptions of their clinician's autonomy supportive communication. We sought to evaluate the psychometric properties of a modified brief version of the Health Care Climate Questionnaire (mHCCQ) adapted for breast cancer patients., Methods: We surveyed 235 women aged 20-79 diagnosed with breast cancer within the previous 18 months at two cancer specialty centers using a print questionnaire. Patients completed the mHCCQ for their surgeon, medical oncologist, and radiation oncologist separately, as well as the overall treatment experience. Exploratory factor analysis (EFA) using principal components was used to explore the factor structure., Results: One hundred sixty out of 235 (68.1%) women completed the survey. Mean age was 57 years and time since diagnosis was 12.6 months. For surgeon, medical oncologist, and radiation oncologist ratings separately, as well as overall treatment, women rated 6 dimensions of perceived physician autonomy support. Exploratory factor analysis indicated a single factor solution for each clinician type and for the overall experience. Further, all six items were retained in each clinician subscore. Internal consistency was 0.93, 0.94, 0.97, and 0.92 for the overall, surgeon, medical oncologist, and radiation oncologist scales, respectively. Hierarchical factor analysis demonstrated that a summary score of the overall treatment experience accounts for only 52% of the total variance observed in ratings of autonomy support for the three provider types., Conclusions: These results describe the first use of the mHCCQ in cancer patients. Ratings of the overall treatment experience account for only half of the variance in ratings of autonomy support, suggesting that patients perceive and report differences in communication across provider types. Future research is needed to evaluate the relationship between physician communication practices and the quality of decision making, as well as other outcomes among cancer patients.

Background: Existing physical activity surveys have not been validated for use with low-income overweight and obese young mothers. This study aimed to validate the Pregnancy Infection and Nutrition 3 (PIN3) physical activity survey and to explore whether its validity varied by race/ethnicity and body mass index (BMI) category when including or excluding child and adult care activities in the target population., Methods: Participants were recruited from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and were asked to fill out the PIN3 survey and wear an Actigraph accelerometer. Validity was assessed (N = 42) using Spearman correlation coefficient., Results: Regardless of inclusion or exclusion of child and adult care activity, the PIN3 survey showed evidence of validity for moderate (correlation coefficients 0.33 [p = 0.03]; 0.40 [p = 0.08]) but not vigorous (-0.01 [p = 0.91]; -0.06 [p = 0.69]) physical activity. The mean minutes per week spent in moderate, vigorous and moderate-vigorous physical activity measured by the PIN3 were substantially higher than when measured by accelerometer, for example, 588 (PIN3) versus 148 (accelerometer) minutes per week. Also, correlations between self-reported and objective monitored activity varied substantially by race/ethnicity and BMI category, for example, 0.29 (p = 0.18) for overweight women versus 0.57 (p = 0.007) for obese women; 0.27 (p = 0.20) for African American versus 0.66 (p = 0.001) for white., Conclusions: The PIN3 survey may be adequate for many applications where quick and practical assessments are needed for moderate physical activity data in low-income overweight and obese young mothers. The substantial differences in mean minutes per week between the PIN3 and accelerometer may be due to over-reported physical activity by the study participants., Trial Registration: Clinical Trials Number: NCT01839708.

Background: Breast cancer patients face several preference-sensitive treatment decisions. Feelings such as regret or having had inadequate information about these decisions can significantly alter patient perceptions of recovery and recurrence. Numerous objective measures of decision quality (e.g., knowledge assessments, values concordance measures) have been developed; there are far fewer measures of subjective decision quality and little consensus regarding how the construct should be assessed. The current study explores the psychometric properties of a new subjective quality decision measure for breast cancer treatment that could be used for other preference sensitive decisions., Methods: 320 women aged 20-79 diagnosed with AJCC stage 0 - III breast cancer were surveyed at two cancer specialty centers. Decision quality was assessed with single items representing six dimensions: regret, satisfaction, and fit as well as perceived adequacy of information, time, and involvement. Women rated decision quality for their overall treatment experience and surgery, chemotherapy, and radiation decisions separately. Principle components was used to explore factor structure. After scales were formed, internal consistency was computed using Cronbach's alpha. The association of each of the four final scales with patient characteristics scores was examined by Pearson correlation., Results: For overall breast cancer treatment as well as surgery, chemotherapy, and radiation decisions, the six items yielded a single factor solution. Factor loadings of the six decision items were all above .45 across the overall and treatment-specific scales, with the exception of "Right for You" for chemotherapy and radiation. Internal consistency was 0.77, 0.85, 0.82, and 0.78 for the overall, surgery, chemotherapy, and radiation decision quality scales, respectively., Conclusions: Our measure of subjective appraisal of breast cancer treatment decisions includes 5 related elements; regret and satisfaction as well as perceived adequacy of information, time, and involvement. Future research is needed to establish norms for the measure as is further psychometric testing, particularly to examine how it is associated with outcomes such as quality of life, psychological coping and objective decision quality.

Background: Over 45% of American women 20-39 years old are at risk for type 2 diabetes, cardiovascular disease, and other health conditions because they are overweight or obese. The prevalence of overweight and obesity is disproportionately high among low-income women. This paper describes the study design and rationale of a community based intervention (Mothers In Motion, MIM) aimed to prevent weight gain among low-income overweight and obese mothers 18-39 years old by promoting stress management, healthy eating, and physical activity., Methods/design: Peer recruiters approach participants from 5 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in Michigan. The MIM delivers theory-based, culturally-sensitive intervention messages via a combination of DVDs and peer support group teleconferences (PSGTs). The DVD features African American and white overweight and obese WIC mothers who participated in a healthy lifestyle intervention patterned after MIM. The PSGTs are led by paraprofessionals from Michigan State University Extension and WIC providers in Michigan who are trained in motivational interviewing and group facilitation skills. Participants are randomly assigned to an intervention (n=350) or comparison group (n=175). The intervention group receives a 16-week intervention on a weekly or bi-weekly basis. Participants are asked to watch 10 MIM DVD chapters at home and join 10 PSGT sessions by phone. The comparison group receives printed educational materials. The primary outcome is body weight. Secondary outcomes include dietary fat, fruit, and vegetable intake; physical activity; stress, and affect. Mediators are self-efficacy, emotional coping response, social support, and autonomous motivation. Telephone interviews and in-person data collection at WIC offices occur at 3 time points: baseline, immediately, and 3 months after the 16-week intervention., Discussion: If MIM shows effectiveness, it could have a favorable impact on public health and community programs. The DVDs and PSGTs will be disseminated in WIC, Extension, clinical practice that promote healthy lifestyles for similar target audiences to make a broad contribution to the prevention of weight gain in low-income mothers. Also, our methodology can be adapted by researchers and community stakeholders to help other low-income populations prevent weight gain., Trial Registration: Clinical Trials Number: NCT01839708.

Background: African American smokers experience disproportionately higher rates of tobacco-related illnesses compared to Caucasians. It has been suggested that interventions targeted to specific racial/ethnic groups (i.e., culturally specific) are needed; however, the literature examining the efficacy of culturally specific interventions is equivocal. Moreover, there are few descriptions of methods used to create these interventions. The main aim of this study is to test the efficacy of a culturally specific smoking cessation intervention among African Americans., Methods/design: A 2-arm randomized controlled trial (RCT) will be conducted to assess the efficacy of a culturally specific group cognitive behavioral therapy (CBT), compared to standard group CBT among treatment-seeking smokers from the community. Participants in both conditions receive the transdermal nicotine patch (TNP) for 8-weeks. We intend to randomize at least 247 adult smokers who self-identify as African American into the trial. Enrolled participants are block randomized into one of two groups: Standard group CBT (control) or a culturally specific group CBT (CS-CBT). Groups are matched for time and attention, and consist of eight sessions. The primary outcome variable is 7-day point prevalence abstinence (7-day ppa). Smoking status is assessed at the end-of-counseling (EOC), and 3, 6, and 12-month follow-ups, with self-reported abstinence verified by saliva cotinine. We hypothesize that the CS-CBT condition will produce significantly greater smoking cessation rates compared to the control condition. We also expect that this effect will be moderated by acculturation and ethnic identity, such that the CS-CBT will show the greatest effect on cessation among participants who are less acculturated and have greater ethnic identity., Discussion: Answering the fundamental question of whether culturally specific interventions lead to incremental efficacy over established, evidence-based approaches is of utmost importance. This study will have implications for the development and implementation of smoking cessation interventions among African Americans and other racial/ethnic minority groups., Trial Registration: NCT01811758.

Background: Increasing moderate to vigorous physical activity among urban girls of low socioeconomic status is both a challenge and a public health priority. Physical activity interventions targeting exclusively girls remain limited, and maintenance of moderate to vigorous physical activity during the post-intervention period has been difficult to maintain. The main aim of the 5-year "Girls on the Move" group randomized trial is to evaluate the efficacy of a comprehensive school-based intervention in increasing girls' minutes of moderate to vigorous physical activity and improving cardiovascular fitness, body mass index, and percent body fat immediately post-intervention (after 17 weeks) and at 9-month post-intervention follow-up (9 months after end of intervention)., Methods/design: A total of 24 urban middle schools in the Midwestern U.S. will be randomized to either receive the intervention or serve as a control (N = 1200 girls). The intervention, based on the Health Promotion Model and Self-Determination Theory, will include: (1) two face-to-face motivational, individually tailored counseling sessions with a registered nurse, one at the beginning and the other at the end of the intervention period; (2) an interactive Internet-based session during which each girl receives individually tailored motivational and feedback messages via iPad at 11 weeks (shortly after midpoint of intervention); and (3) a 90-minute after-school physical activity club. Racially diverse, low-active, 10- to 14-year-old 5th to 8th-grade girls will complete questionnaires and physical measures at baseline and post-intervention (n = 50 per school). Minutes of moderate to vigorous physical activity will be assessed with accelerometers. Cardiovascular fitness will be assessed by estimating VO2 max with PACER (Progressive Aerobic Cardiovascular Endurance Run) scores. Height and weight will be assessed to calculate body mass index. Percent body fat will be estimated with a foot-to-foot bioelectric impedance scale. Linear mixed effects regression analyses will be performed to assess intervention effects., Discussion: This multi-component approach is expected to improve girls' moderate to vigorous physical activity and related physical outcomes., Trial Registration: ClinicalTrials.gov Identifier NCT01503333.

Background: Smoking, poor diet, and physical inactivity account for as much as 60% of cancer risk. Latinos experience profound disparities in health behaviors, as well as the cancers associated with them. Currently, there is a dearth of controlled trials addressing these health behaviors among Latinos. Further, to the best of our knowledge, no studies address all three behaviors simultaneously, are culturally sensitive, and are guided by formative work with the target population. Latinos represent 14% of the U.S. population and are the fastest growing minority group in the country. Efforts to intervene on these important lifestyle factors among Latinos may accelerate the elimination of cancer-related health disparities., Methods/design: The proposed study will evaluate the efficacy of an evidence-based and theoretically-driven Motivation And Problem Solving (MAPS) intervention, adapted and culturally-tailored for reducing cancer risk related to smoking, poor diet, and physical inactivity among high-risk Mexican-origin smokers who are overweight/obese (n = 400). Participants will be randomly assigned to one of two groups: Health Education (HE) or MAPS (HE + up to 18 MAPS counseling calls over 18 months). Primary outcomes are smoking status, servings of fruits and vegetables, and both self-reported and objectively measured physical activity. Outcome assessments will occur at baseline, 6 months, 12 months, and 18 months., Discussion: The current study will contribute to a very limited evidence base on multiple risk factor intervention studies on Mexican-origin individuals and has the potential to inform both future research and practice related to reducing cancer risk disparities. An effective program targeting multiple cancer risk behaviors modeled after chronic care programs has the potential to make a large public health impact because of the dearth of evidence-based interventions for Latinos and the extended period of support that is provided in such a program., Trial Registration: National Institutes of Health Clinical Trials Registry # NCT01504919.

Background: Although the current Clinical Practice Guideline recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition., Methods/design: A sample of adult community resident smokers (N = 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing's effect on cessation., Discussion: This trial will provide the most rigorous evaluation to date of Motivational Interviewing's efficacy for encouraging unmotivated smokers to make a quit attempt. It will also provide effect-size estimates of MI's impact on smoking cessation to inform future clinical trials and inform the Clinical Practice Guideline., Trial Registration: ClinicalTrials.gov NCT01188018.

Clinical interventions can be developed through two distinct pathways. In the first, which we call top-down, a well-articulated theory drives the development of the intervention, whereas in the case of a bottom-up approach, clinical experience, more so than a dedicated theoretical perspective, drives the intervention. Using this dialectic, this paper discusses Self-Determination Theory (SDT) 12 and Motivational Interviewing (MI) 3 as prototypical examples of a top-down and bottom-up approaches, respectively. We sketch the different starting points, foci and developmental processes of SDT and MI, but equally note the complementary character and the potential for systematic integration between both approaches. Nevertheless, for a deeper integration to take place, we contend that MI researchers might want to embrace autonomy as a fundamental basic process underlying therapeutic change and we discuss the advantages of doing so.

Background: A large proportion of adults fail to meet public health guidelines for physical activity as well as fruit, vegetable and fat intake. Interventions are needed to improve these health behaviors. Both computer tailoring and motivational interviewing have shown themselves to be promising techniques for health behavior change. The Vitalum project aims to compare the efficacy of these techniques in improving the health behaviors of adults aged 45-70. This paper describes the design of the Vitalum study., Methods/design: Dutch general medical practices (N = 23) were recruited via a registration network or by personal invitation. The participants were then enrolled through these general practices using an invitational letter. They (n = 2,881) received a written baseline questionnaire to assess health behaviors, and potential psychosocial and socio-demographic behavioral determinants. A power analysis indicated that 1,600 participants who were failing to meet the guidelines for physical activity and either fruit or vegetable consumption were needed. Eligible participants were stratified based on hypertension status and randomized into one of four intervention groups: tailored print communication, telephone motivational interviewing, combined, and control. The first two groups either received four letters or took part in four interviews, whereas the combined group received two letters and took part in two interviews in turns at 5, 13, 30 and 43 weeks after returning the baseline questionnaire. Each letter and interview focused on physical activity or nutrition behavior. The participants also took part in a telephone survey 25 weeks after baseline to gather new information for tailoring. There were two follow-up questionnaires, at 47 and 73 weeks after baseline, to measure short- and long-term effects. The control group received a tailored letter after the last posttest. The process, efficacy and cost-effectiveness of the interventions will be examined by means of multilevel mixed regression, cost-effectiveness analyses and process evaluation., Discussion: The Vitalum study simultaneously evaluates the efficacy of tailored print communication and telephone motivational interviewing, and their combined use for multiple behaviors and people with different motivational stages and education levels. The results can be used by policymakers to contribute to evidence-based prevention of chronic diseases., Trial Registration: Dutch Trial Register NTR1068.

Background: The study of health behavior change, including nutrition and physical activity behaviors, has been rooted in a cognitive-rational paradigm. Change is conceptualized as a linear, deterministic process where individuals weigh pros and cons, and at the point at which the benefits outweigh the cost change occurs. Consistent with this paradigm, the associated statistical models have almost exclusively assumed a linear relationship between psychosocial predictors and behavior. Such a perspective however, fails to account for non-linear, quantum influences on human thought and action. Consider why after years of false starts and failed attempts, a person succeeds at increasing their physical activity, eating healthier or losing weight. Or, why after years of success a person relapses. This paper discusses a competing view of health behavior change that was presented at the 2006 annual ISBNPA meeting in Boston., Discussion: Rather than viewing behavior change from a linear perspective it can be viewed as a quantum event that can be understood through the lens of Chaos Theory and Complex Dynamic Systems. Key principles of Chaos Theory and Complex Dynamic Systems relevant to understanding health behavior change include: 1) Chaotic systems can be mathematically modeled but are nearly impossible to predict; 2) Chaotic systems are sensitive to initial conditions; 3) Complex Systems involve multiple component parts that interact in a nonlinear fashion; and 4) The results of Complex Systems are often greater than the sum of their parts. Accordingly, small changes in knowledge, attitude, efficacy, etc may dramatically alter motivation and behavioral outcomes. And the interaction of such variables can yield almost infinite potential patterns of motivation and behavior change. In the linear paradigm unaccounted for variance is generally relegated to the catch all "error" term, when in fact such "error" may represent the chaotic component of the process. The linear and chaotic paradigms are however, not mutually exclusive, as behavior change may include both chaotic and cognitive processes. Studies of addiction suggest that many decisions to change are quantum rather than planned events; motivation arrives as opposed to being planned. Moreover, changes made through quantum processes appear more enduring than those that involve more rational, planned processes. How such processes may apply to nutrition and physical activity behavior and related interventions merits examination.