Does Social Support Really Help to Eat a Low-Fat Diet? Main Effects and Gender Differences of Received Social Support within the Health Action Process Approach

BACKGROUND: Most theories of health-behavior change focus exclusively on individual self-regulation without taking social factors, such as social support, into account. This study's first aim was to systematically test the added value of received instrumental and emotional social support within the Health Action Process Approach (HAPA) in the context of dietary change. In the social support literature, gender effects emerge with regard to the effectiveness of social support. Thus, a second aim was the examination of gender differences in the association of social support with dietary behavior. METHODS: Participants were 252 overweight and obese individuals. At baseline and 12 months later, participants completed questionnaires on HAPA variables; diet-specific received social support and low-fat diet. RESULTS: For the prediction of intentions 12 months later, instrumental support was more beneficial for men than for women over and above individual self-regulation. In terms of dietary behavior at T2, a moderate main effect of instrumental support emerged. Moreover, received emotional social support was beneficial for men, but not for women in terms of a low-fat diet 12 months later. CONCLUSIONS: Effects of received instrumental social support found in this study provide new evidence for the added value of integrating social support into the HAPA.

Predicting Physical Activity in Adolescents: The Role of Compensatory Health Beliefs within the Health Action Process Approach

Objective: Compensatory health beliefs (CHBs), defined as beliefs that healthy behaviours can compensate for unhealthy behaviours, may be one possible factor hindering people in adopting a healthier lifestyle. This study examined the contribution of CHBs to the prediction of adolescents’ physical activity within the theoretical framework of the Health Action Process Approach (HAPA). Design: The study followed a prospective survey design with assessments at baseline (T1) and two weeks later (T2). Method: Questionnaire data on physical activity, HAPA variables and CHBs were obtained twice from 430 adolescents of four different Swiss schools. Multilevel modelling was applied. Results: CHBs added significantly to the prediction of intentions and change in intentions, in that higher CHBs were associated with lower intentions to be physically active at T2 and a reduction in intentions from T1 to T2. No effect of CHBs emerged for the prediction of self-reported levels of physical activity at T2 and change in physical activity from T1 to T2. Conclusion: Findings emphasise the relevance of examining CHBs in the context of an established health behaviour change model and suggest that CHBs are of particular importance in the process of intention formation.

The Process-Outcome Mindfulness Effects in Trainees (PrOMET) study: protocol of a pragmatic randomized controlled trial

Background Mindfulness has its origins in an Eastern Buddhist tradition that is over 2500 years old and can be defined as a specific form of attention that is non-judgmental, purposeful, and focused on the present moment. It has been well established in cognitive-behavior therapy in the last decades, while it has been investigated in manualized group settings such as mindfulness-based stress reduction and mindfulness-based cognitive therapy. However, there is scarce research evidence on the effects of mindfulness as a treatment element in individual therapy. Consequently, the demand to investigate mindfulness under effectiveness conditions in trainee therapists has been highlighted. Methods/Design To fill in this research gap, we designed the PrOMET Study. In our study, we will investigate the effects of brief, audiotape-presented, session-introducing interventions with mindfulness elements conducted by trainee therapists and their patients at the beginning of individual therapy sessions in a prospective, randomized, controlled design under naturalistic conditions with a total of 30 trainee therapists and 150 patients with depression and anxiety disorders in a large outpatient training center. We hypothesize that the primary outcomes of the session-introducing intervention with mindfulness elements will be positive effects on therapeutic alliance (Working Alliance Inventory) and general clinical symptomatology (Brief Symptom Checklist) in contrast to the session-introducing progressive muscle relaxation and treatment-as-usual control conditions. Treatment duration is 25 therapy sessions. Therapeutic alliance will be assessed on a session-to-session basis. Clinical symptomatology will be assessed at baseline, session 5, 15 and 25. We will conduct multilevel modeling to address the nested data structure. The secondary outcome measures include depression, anxiety, interpersonal functioning, mindful awareness, and mindfulness during the sessions. Discussion The study results could provide important practical implications because they could inform ideas on how to improve the clinical training of psychotherapists that could be implemented very easily; this is because there is no need for complex infrastructures or additional time concerning these brief session-introducing interventions with mindfulness elements that are directly implemented in the treatment sessions.

Inter- and intraindividual associations between volitional processes and daily smoking during a quit attempt

Background: The Health Action Process Approach (HAPA) assumes that volitional processes are important for effective behavioral change. This study examined the associations of volitional predictors and daily smoking in quitters at the inter- and intraindividual level. Method: Overall, 105 smokers completed daily electronic questionnaires 10 days before and 21 days after a self-set quit date, assessing intentions, self-efficacy, planning, action control and numbers of cigarettes smoked. Findings: Multilevel analyses showed that mean levels of volitional predictors across the 32 days were negatively associated with numbers of cigarettes smoked. Moreover, on days with higher intentions, self-efficacy, planning and action control than usual, less cigarettes were smoked. These effects were stronger after the quit date than before the quit date. Intentions and action control emerged as most powerful predictors at the intraindividual level. Discussion: Findings emphasize the importance of volitional processes at the intraindividual level in the context of quitting smoking.

Predicting daily smoking around a quit date : Volitional processes at the inter- and intraindividual level

Background: The health action process approach (hapa) is a well-established model in predicting health behavior and assumes that volitional processes are important for effective behavioral change. however, only few studies have so far tested associations on the intraindividual level. thus, this study examined the inter- and intraindividual associations between volitional predictors and daily smoking around a quit attempt. method: overall, 105 smokers completed daily electronic questionnaires 10 days before and 21 days after a self-set quit date, including measures of intentions, self-efficacy, planning, action control and numbers of cigarettes smoked. multilevel analysis was applied. findings: at the interindividual level, higher mean levels of volitional predictors across the 32 days were associated with less numbers of cigarettes smoked. negative associations emerged also at the intraindividual level, indicating that on days with higher intentions, self-efficacy, planning and action control than usual, less cigarettes were smoked. moreover, these effects were stronger after the quit date than before the quit date. intentions and action control emerged as most powerful predictors at the intraindividual level. discussion: findings confirm assumptions of the hapa and emphasize the importance of volitional processes at the inter- and intraindividual level in the context of quitting smoking.

Social and cognitive predictors of fruit and vegetable intake among adolescents: The context of changes in body weight

Two studies investigated differences in the relationships between adolescents' fruit and vegetable intake (FVI) and the predictors specified in the Health Action Process Approach and Social-Cognitive Theory. Retrospective (Study 1; N = 502) and prospective (Study 2; N = 668) designs were applied. Among adolescents with overweight/obesity, intention was cross-sectionally associated with FVI (Study 1); no social or cognitive predictors explained FVI at 14-month follow-up (Study 2). The planning - FVI and self-efficacy - FVI relationships were stronger among adolescents who reduced their body weight to normal, compared to effects observed among those who maintained their body weight (Studies 1 and 2).

Dyadic action control in overweight and obese couples: Effectiveness of a randomized controlled trial to promote physical activity.

BACKGROUND: Enhancing physical activity in overweight and obese individuals is an important means to promote health in this target population. The Health Action Process Approach (HAPA), which was the theoretical framework of this study, focuses on individual self-regulation variables for successful health behavior change. One key self-regulation variable of this model is action control with its three subfacets awareness of intentions, self-monitoring and regulatory effort. The social context of individuals, however, is usually neglected in common health behavior change theories. In order to integrate social influences into the HAPA, this randomized controlled trial investigated the effectiveness of a dyadic conceptualization of action control for promoting physical activity. METHODS/DESIGN: This protocol describes the design of a single-blind randomized controlled trial, which comprises four experimental groups: a dyadic action control group, an individual action control group and two control groups. Participants of this study are overweight or obese, heterosexual adult couples who intend to increase their physical activity. Blocking as means of a gender-balanced randomization is used to allocate couples to conditions and partners to either being the target person of the intervention or to the partner condition. The ecological momentary intervention takes place in the first 14 days after baseline assessment and is followed by another 14 days diary phase without intervention. Follow-ups are one month and six months later. Subsequent to the six-months follow-up another 14 days diary phase takes place.The main outcome measures are self-reported and accelerometer-assessed physical activity. Secondary outcome measures are Body Mass Index (BMI), aerobic fitness and habitual physical activity. DISCUSSION: This is the first study examining a dyadic action control intervention in comparison to an individual action control condition and two control groups applying a single-blind randomized control trial. Challenges with running couples studies as well as advantages and disadvantages of certain design-related decisions are discussed. This RCT was funded by the Swiss National Science Foundation (PP00P1_133632/1) and was registered on 27/04/2012 at http://www.isrctn.com/ISRCTN15705531.

Volitional processes and daily smoking: Examining inter- and intraindividual associations around a quit attempt

The Health Action Process Approach (HAPA) assumes that volitional processes are important for effective behavioral change. However, intraindividual associations have not yet been tested in the context of smoking cessation. This study examined the inter- and intraindividual associations between volitional HAPA variables and daily smoking before and after a quit attempt. Overall, 100 smokers completed daily surveys on mobile phones from 10 days before until 21 days after a self-set quit date, including self-efficacy, action planning, action control, and numbers of cigarettes smoked. Negative associations between volitional variables and daily numbers of cigarettes smoked emerged at the inter- and intraindividual level. Except for interindividual action planning, associations were stronger after the quit date than before the quit date. Self-efficacy, planning and action control were identified as critical inter- and intraindividual processes in smoking cessation, particularly after a self-set quit attempt when actual behavior change is performed.

A Dyadic Action Control Trial in Overweight and Obese Couples (DYACTIC)

BACKGROUND: Enhancing physical activity in overweight and obese individuals is an important means to promote health in this target population. The Health Action Process Approach (HAPA), which was the theoretical framework of this study, focuses on individual self-regulation variables for successful health behavior change. One key self-regulation variable of this model is action control with its three subfacets awareness of intentions, self-monitoring and regulatory effort. The social context of individuals, however, is usually neglected in common health behavior change theories. In order to integrate social influences into the HAPA, this randomized controlled trial investigated the effectiveness of a dyadic conceptualization of action control for promoting physical activity. METHODS/DESIGN: This protocol describes the design of a single-blind randomized controlled trial, which comprises four experimental groups: a dyadic action control group, an individual action control group and two control groups. Participants of this study are overweight or obese, heterosexual adult couples who intend to increase their physical activity. Blocking as means of a gender-balanced randomization is used to allocate couples to conditions and partners to either being the target person of the intervention or to the partner condition. The ecological momentary intervention takes place in the first 14 days after baseline assessment and is followed by another 14 days diary phase without intervention. Follow-ups are one month and six months later. Subsequent to the six-months follow-up another 14 days diary phase takes place.The main outcome measures are self-reported and accelerometer-assessed physical activity. Secondary outcome measures are Body Mass Index (BMI), aerobic fitness and habitual physical activity. DISCUSSION: This is the first study examining a dyadic action control intervention in comparison to an individual action control condition and two control groups applying a single-blind randomized control trial. Challenges with running couples studies as well as advantages and disadvantages of certain design-related decisions are discussed. This RCT was funded by the Swiss National Science Foundation (PP00P1_133632/1) and was registered on 27/04/2012 at http://www.isrctn.com/ISRCTN15705531.

Psychological predictors of eco-driving: A longitudinal study

Eco-driving has well-known positive effects on fuel economy and greenhouse-gas emissions. Moreover, eco-driving reduces road-traffic noise, which is a serious threat to the health and well-being of many people. We investigated the psychological predictors of the adoption of eco-driving from the perspective of road-traffic noise abatement. The data came from 890 car drivers who participated in a longitudinal survey over four months. Specifically, we tested the effects of the intention to prevent road-traffic noise, variables derived from the theory of planned behavior (social norm, perceived behavioral control, and attitude), and variables derived from the health action process approach (implementation intention, maintenance self-efficacy, and action control) on the intention to practice eco-driving and on eco-driving behavior. The intention to prevent road-traffic noise was not linked to the intention to practice eco-driving. The strongest predictors of the intention to practice eco-driving were attitude and perceived behavioral control. The strongest predictor of eco-driving behavior was action control. The link between behavioral intention and behavior was weak, indicating that drivers have difficulties putting their intention to practice eco-driving into action. Therefore, intervention efforts should directly address and support the transition from intention to behavior. This could be accomplished by providing reminders, which help to maintain behavioral intention, and by providing behavior feedback, which helps car drivers to monitor their behavior.

Using human rights for sexual and reproductive health: improving legal and regulatory frameworks

This paper describes the development of a tool that uses human rights concepts and methods to improve relevant laws, regulations and policies related to sexual and reproductive health. This tool aims to improve awareness and understanding of States' human rights obligations. It includes a method for systematically examining the status of vulnerable groups, involving non-health sectors, fostering a genuine process of civil society participation and developing recommendations to address regulatory and policy barriers to sexual and reproductive health with a clear assignment of responsibility. Strong leadership from the ministry of health, with support from the World Health Organization or other international partners, and the serious engagement of all involved in this process can strengthen the links between human rights and sexual and reproductive health, and contribute to national achievement of the highest attainable standard of health.

Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool

With the publication of the quality guideline ICH Q9 "Quality Risk Management" by the International Conference on Harmonization, risk management has already become a standard requirement during the life cycle of a pharmaceutical product. Failure mode and effect analysis (FMEA) is a powerful risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to biopharmaceutical processes brings about some difficulties. The proposal presented here is intended to serve as a brief but nevertheless comprehensive and detailed guideline on how to conduct a biopharmaceutical process FMEA. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. The application for such a biopharmaceutical process FMEA is widespread. It can be useful whenever a biopharmaceutical manufacturing process is developed or scaled-up, or when it is transferred to a different manufacturing site. It may also be conducted during substantial optimization of an existing process or the development of a second-generation process. According to their resulting risk ratings, process parameters can be ranked for importance and important variables for process development, characterization, or validation can be identified. LAY ABSTRACT: Health authorities around the world ask pharmaceutical companies to manage risk during development and manufacturing of pharmaceuticals. The so-called failure mode and effect analysis (FMEA) is an established risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to pharmaceutical processes that use modern biotechnology (biopharmaceutical processes) brings about some difficulties, because those biopharmaceutical processes differ from processes in mechanical and electrical industries. The proposal presented here explains how a biopharmaceutical process FMEA can be conducted. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. With the help of this guideline, different details of the manufacturing process can be ranked according to their potential risks, and this can help pharmaceutical companies to identify aspects with high potential risks and to react accordingly to improve the safety of medicines.

Evidence Based Development of a Novel Lateral Fibula Plate (VariAx Fibula) Using a Real CT Bone Data Based Optimization Process During Device Development

Development of novel implants in orthopaedic trauma surgery is based on limited datasets of cadaver trials or artificial bone models. A method has been developed whereby implants can be constructed in an evidence based method founded on a large anatomic database consisting of more than 2.000 datasets of bones extracted from CT scans. The aim of this study was the development and clinical application of an anatomically pre-contoured plate for the treatment of distal fibular fractures based on the anatomical database. 48 Caucasian and Asian bone models (left and right) from the database were used for the preliminary optimization process and validation of the fibula plate. The implant was constructed to fit bilaterally in a lateral position of the fibula. Then a biomechanical comparison of the designed implant to the current gold standard in the treatment of distal fibular fractures (locking 1/3 tubular plate) was conducted. Finally, a clinical surveillance study to evaluate the grade of implant fit achieved was performed. The results showed that with a virtual anatomic database it was possible to design a fibula plate with an optimized fit for a large proportion of the population. Biomechanical testing showed the novel fibula plate to be superior to 1/3 tubular plates in 4-point bending tests. The clinical application showed a very high degree of primary implant fit. Only in a small minority of cases further intra-operative implant bending was necessary. Therefore, the goal to develop an implant for the treatment of distal fibular fractures based on the evidence of a large anatomical database could be attained. Biomechanical testing showed good results regarding the stability and the clinical application confirmed the high grade of anatomical fit.