The HEPHAISTOS study: compliance and adherence with a novel orthotic device for calf muscle unloading.

The present manuscript seeks to discuss methodological aspects regarding the application of the novel unloading orthosis 'HEPHAISTOS' that has been specifically developed to study physiological effects of muscular unloading without altering the impact of gravitational loading. The 'HEPHAISTOS' has been applied in an ambulatory clinical interventional study. During gait, the 'HEPHAISTOS' significantly reduces activation and force production of calf muscles while it completely retains body mass-related force on the tibia. Eleven healthy male subjects participated in the study and followed their normal everyday lives while wearing the orthosis. Several measurement sessions have been performed to investigate the time course of structural and functional adaptations during intervention and recovery. Follow-up measurements were performed for one year after the intervention. In consideration of the experiences of a unique ambulant unloading study, organizational and methodological recommendations are discussed in this manuscript. Activity monitoring data obtained with portable accelerometers reveal unchanged gait activities and good subject compliance throughout the intervention. Moreover, electromyography (EMG) and motion data investigating gait properties on reambulation day are illustrated. These data show that during the initial steps following removal of 'HEPHAISTOS', gait was significantly asynchronous indicating an acutely altered motor control in the unloaded lower leg muscles.

Behavior change in a lifestyle intervention for type 2 diabetes prevention in Dutch primary care: opportunities for intervention content.

BACKGROUND: Despite the favorable effects of behavior change interventions on diabetes risk, lifestyle modification is a complicated process. In this study we therefore investigated opportunities for refining a lifestyle intervention for type 2 diabetes prevention, based on participant perceptions of behavior change progress. METHODS: A 30 month intervention was performed in Dutch primary care among high-risk individuals (FINDRISC-score ≥ 13) and was compared to usual care. Participant perceptions of behavior change progress for losing weight, dietary modification, and increasing physical activity were assessed after18 months with questionnaires. Based on the response, participants were categorized as 'planners', 'initiators' or 'achievers' and frequencies were evaluated in both study groups. Furthermore, participants reported on barriers for lifestyle change. RESULTS: In both groups, around 80% of all participants (intervention: N = 370; usual care: N = 322) planned change. Except for reducing fat intake (p = 0.08), the number of initiators was significantly higher in the intervention group than in usual care. The percentage of achievers was high for the dietary and exercise objectives (intervention: 81-95%; usual care: 83-93%), but was lower for losing weight (intervention: 67%; usual care: 62%). Important motivational barriers were 'I already meet the standards' and 'I'm satisfied with my current behavior'. Temptation to snack, product taste and lack of time were important volitional barriers. CONCLUSIONS: The results suggest that the intervention supports participants to bridge the gap between motivation and action. Several opportunities for intervention refinement are however revealed, including more stringent criteria for participant inclusion, tools for (self)-monitoring of health, emphasis on the 'small-step-approach', and more attention for stimulus control. TRIAL REGISTRATION: Netherlands Trial Register: NTR1082.

Implementation of a lifestyle intervention for type 2 diabetes prevention in Dutch primary care: opportunities for intervention delivery.

BACKGROUND: As in clinical practice resources may be limited compared to experimental settings, translation of evidence-based lifestyle interventions into daily life settings is challenging. In this study we therefore evaluated the implementation of the APHRODITE lifestyle intervention for the prevention of type 2 diabetes in Dutch primary care. Based on this evaluation we discuss opportunities for refining intervention delivery. METHODS: A 2.5-year intervention was performed in 14 general practices in the Netherlands among individuals at high risk for type 2 diabetes (FINDRISC-score ≥ 13) (n = 479) and was compared to usual care (n = 446). Intervention consisted of individual lifestyle counselling by nurse practitioners (n = 24) and GPs (n = 48) and group-consultations. Drop-out and attendance were registered during the programme. After the intervention, satisfaction with the programme and perceived implementation barriers were assessed with questionnaires. RESULTS: Drop-out was modest (intervention: 14.6 %; usual care: 13.2 %) and attendance at individual consultations was high (intervention: 80-97 %; usual care: 86-94 %). Providers were confident about diabetes prevention by lifestyle intervention in primary care. Participants were more satisfied with counselling from nurse practitioners than from GPs. A major part of the GPs reported low self-efficacy regarding dietary guidance. Lack of counselling time (60 %), participant motivation (12 %), and financial reimbursement (11 %) were regarded by providers as important barriers for intervention implementation. CONCLUSIONS: High participant compliance and a positive attitude of providers make primary care a suitable setting for diabetes prevention by lifestyle counselling. Results support a role for the nurse practitioner as the key player in guiding lifestyle modification. Further research is needed on strategies that could increase cost-effectiveness, such as more stringent criteria for participant inclusion, group-counselling, more tailor-made counselling and integration of screening and / or interventions for different disorders.