Physical activity promotion in the primary care setting in pre- and type 2 diabetes - the Sophia step study, an RCT.

BACKGROUND: Physical activity prevents or delays progression of impaired glucose tolerance in high-risk individuals. Physical activity promotion should serve as a basis in diabetes care. It is necessary to develop and evaluate health-promoting methods that are feasible as well as cost-effective within diabetes care. The aim of Sophia Step Study is to evaluate the impact of a multi-component and a single component physical activity intervention aiming at improving HbA1c (primary outcome) and other metabolic and cardiovascular risk factors, physical activity levels and overall health in patients with pre- and type 2 diabetes. METHODS/DESIGN: Sophia Step Study is a randomized controlled trial and participants are randomly assigned to either a multi-component intervention group (A), a pedometer group (B) or a control group (C). In total, 310 patients will be included and followed for 24 months. Group A participants are offered pedometers and a website to register steps, physical activity on prescription with yearly follow-ups, motivational interviewing (10 occasions) and group consultations (including walks, 12 occasions). Group B participants are offered pedometers and a website to register steps. Group C are offered usual care. The theoretical framework underpinning the interventions is the Health Belief Model, the Stages of Change Model, and the Social Cognitive Theory. Both the multi-component intervention (group A) and the pedometer intervention (group B) are using several techniques for behavior change such as self-monitoring, goal setting, feedback and relapse prevention. Measurements are made at week 0, 8, 12, 16, month 6, 9, 12, 18 and 24, including metabolic and cardiovascular biomarkers (HbA1c as primary health outcome), accelerometry and daily steps. Furthermore, questionnaires were used to evaluate dietary intake, physical activity, perceived ability to perform physical activity, perceived support for being active, quality of life, anxiety, depression, well-being, perceived treatment, perceived stress and diabetes self- efficacy. DISCUSSION: This study will show if a multi-component intervention using pedometers with group- and individual consultations is more effective than a single- component intervention using pedometers alone, in increasing physical activity and improving HbA1c, other metabolic and cardiovascular risk factors, physical activity levels and overall health in patients with pre- and type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02374788 . Registered 28 January 2015.

Evaluation of insulin initiation on resource utilization and direct costs of treatment over 12 months in patients with type 2 diabetes in Europe: results from INSTIGATE and TREAT observational studies.

OBJECTIVES: To describe the changes in resource utilization in seven European countries (Germany, Greece, Portugal, Romania, Sweden, Spain, and Turkey) and direct costs in four European countries (Germany, Spain, Sweden, and Greece) over the first 12 months of insulin treatment in patients with type 2 diabetes mellitus (T2DM). METHODS: INSTIGATE and TREAT (2005-2010) were non-interventional, prospective, observational studies in patients with T2DM and initiating insulin for the first time. A 6-month retrospective data capture was conducted at baseline (insulin initiation) followed by prospective data collections at ∼3, 6, and 12 months. Statistical analyses were descriptive; estimated costs are presented as nominal values. RESULTS: This study presents data for 1450 patients. Overall, in the first 6 months after insulin initiation, the use and cost of blood glucose monitoring and insulin increased, while the cost of oral diabetic medication decreased. Contributors to total direct costs differed between countries. Ranges of total mean direct costs over the 6-month period before insulin initiation were €489.10-€658.50 (Greece-Spain); 0-6 months after insulin initiation, €573.40-€1084.70 (Greece-Spain); and 6-12 months after insulin initiation, €495.80-€859.30 (Greece-Germany). Thus, the mean cost of treatment increased in all countries in the first 6 months after insulin initiation and then returned to baseline except in Germany. LIMITATIONS: Overall, 15% of patients were lost to follow-up over 12 months. Costs were not pro-rated to account for variation of visits. Participating centres may not have been fully representative of all levels of care. CONCLUSIONS: Contributors to total cost differed between countries, potentially reflecting local clinical practice patterns and insulin regimens. In each country, mean direct total costs of T2DM care increased during the first 6 months after insulin initiation and decreased thereafter.

Nutritional status using mini nutritional assessment and subjective global assessment predict mortality in geriatric patients.

OBJECTIVES: To evaluate the clinical assessment of nutritional status and mortality in geriatric patients. DESIGN: Prospective follow-up study. SETTING: Acute geriatric inpatient ward. PARTICIPANTS: Eighty-three consecutive acute geriatric patients (mean age +/- standard deviation = 83 +/- 7; 68% women). MEASUREMENTS: Patients were classified as (1) having protein-energy malnutrition (PEM), (2) having moderate PEM or being at risk for PEM, or (3) being well nourished according to Subjective Global Assessment (SGA) and Mini Nutritional Assessment (MNA). Body mass index ((BMI) kg/m2), arm anthropometry, and handgrip strength were determined. In a subgroup of patients (n = 39), body composition was analyzed using dual energy x-ray absorption and bioelectrical impedance. Three-year mortality data were obtained from the Swedish population records. RESULTS: Twenty percent and 26% of the patients were classified as having PEM based on SGA and MNA, respectively, whereas 43% and 56%, respectively, were classified as having moderate PEM or being at risk for PEM. Objective measures, such as BMI, arm anthropometry, handgrip, and body fat were 20% to 50% lower in the malnourished group than in the well-nourished subjects (P <.05). Moreover, mortality was higher in those classified as being malnourished, ranging from 40% after 1 year to 80% after 3 years, compared with 20% after 1 year (P =.03-0.17) and 50% after 3 years (P <.01) in patients classified as being well nourished. CONCLUSION: Fewer than one-third of newly admitted geriatric patients had a normal nutritional status according to SGA and MNA. BMI, arm anthropometry, body fat mass, and handgrip strength were reduced, and 1-, 2-, and 3-year mortality was higher in patients classified as malnourished. The present data justify the use of SGA and MNA for the assessment of nutritional status in geriatric patients.