Fruit, berry, and vegetable consumption and the risk of islet autoimmunity and type 1 diabetes in children-the Type 1 Diabetes Prediction and Prevention birth cohort study.

BACKGROUND: Prospective studies investigating the association among fruit, berry, and vegetable consumption and the risk of islet autoimmunity (IA) and type 1 diabetes (T1D) are few. OBJECTIVES: In this cohort study, we explored whether the consumption of fruits, berries, and vegetables is associated with the IA and T1D development in genetically susceptible children. METHODS: Food consumption data in the Finnish Type 1 Diabetes Prediction and Prevention (DIPP) cohort study were available from 5674 children born between September 1996 and September 2004 in the Oulu and Tampere University Hospitals. Diet was assessed with 3-d food records at the age of 3 and 6 mo and annually from 1 to 6 y. The association between food consumption and the risk of IA and T1D was analyzed using joint models adjusted for energy intake, sex, human leukocyte antigen (HLA) genotype, and a family history of diabetes. RESULTS: During the 6-y follow-up, 247 children (4.4%) developed IA and 94 (1.7%) T1D. Furthermore, 64 of 505 children with at least 1 repeatedly positive autoantibody (12.7%) progressed from islet autoantibody positivity to T1D. The consumption of cruciferous vegetables was associated with decreased risk of IA [hazard ratio (HR): 0.83; 95% credible intervals (CI): 0.72, 0.95, per 1 g/MJ increase in consumption] and the consumption of berries with decreased risk of T1D (0.60; 0.47, 0.89). The consumption of banana was associated with increased risk of IA (1.08; 1.04, 1.12) and T1D (1.11; 1.01, 1.21). Only the association between banana and IA remain significant after multiple testing correction. CONCLUSIONS: In children genetically at risk for T1D, the consumption of cruciferous vegetables was associated with decreased risk of IA and consumption of berries with decreased risk of T1D. In addition, the consumption of banana was associated with increased risk of IA and T1D.

Associations Between Engagement with the BitHabit Digital Lifestyle Intervention and Changes in Type 2 Diabetes Risk Factors.

Type 2 diabetes (T2D) can be prevented or delayed through a healthy lifestyle. Digital behavior change interventions (DBCIs) may offer cost-effective and scalable means to support lifestyle changes. This study investigated associations between user engagement with a habit-formation-based DBCI, the BitHabit app, and changes in T2D risk factors over 12 months in 963 participants at risk of T2D. User engagement was characterized by calculating use metrics from the BitHabit log data. User ratings were used as a subjective measure of engagement. The use metrics and user ratings were the strongest associated with improvements in diet quality. Weak positive associations were observed between the use metrics and changes in waist circumference and body mass index. No associations were found with changes in physical activity, fasting plasma glucose, or plasma glucose two hours after an oral glucose tolerance test. To conclude, increased use of the BitHabit app can have beneficial impacts on T2D risk factors, especially on diet quality.

Longitudinal consumption of fruits and vegetables and risk of asthma by 5 years of age.

BACKGROUND: Fruit and vegetable consumption has been linked to a decreased risk of asthma, but prospective evidence on longitudinal consumption in childhood is scarce. We aimed to investigate the association between fruit and vegetable consumption in childhood and the risk of asthma by the age of 5 years, and to explore the role of processing of fruits and vegetables in the Finnish Type 1 Diabetes Prediction and Prevention Allergy Study. METHODS: Child's food consumption was assessed by 3-day food records completed at the age of 3 and 6 months, and 1, 2, 3, 4, and 5 years, and asthma and allergies by a validated modified version of the ISAAC questionnaire at the age of 5 years. Consumption of processed and unprocessed fruits and vegetables was calculated. Joint models with a current value association structure for longitudinal and time-to-event data were used for statistical analyses. RESULTS: Of the 3053 children, 184 (6%) developed asthma by the age of 5 years. The risk of asthma was not associated with the consumption of all fruits and vegetables together (HR 1.00, 95%CI 0.99-1.01 per consumption of 1 g/MJ, adjusted for energy and other covariates), or with most subgroups. Weak inverse associations were seen between all leafy vegetables and asthma (HR = 0.87, 0.77-0.99), and unprocessed vegetables and nonatopic asthma (HR = 0.90, 95% CI 0.81-0.98). CONCLUSION: Total consumption of fruits and vegetables in childhood was not associated with the development of asthma by the age of 5 years. Weak inverse associations found for vegetables need to be confirmed or rejected in future studies.

Pharmacogenetics of warfarin and healthcare costs - Real-world data analysis.

PURPOSE: Variants in CYP2C9 and VKORC1 genes have been associated with individuals' sensitivity to warfarin. The aim of this study was to investigate the differences of healthcare costs of genetically normal and genetically sensitive warfarin responder groups. METHODS: This was a retrospective study linking genotype data from three Finnish biobanks (THL Biobank, Auria Biobank, Helsinki Biobank) with healthcare encounter data of the Finnish Institute of Health and Welfare (THL), drug dispensation data from the Social Insurance Institution of Finland (Kela) and laboratory data from Finnish hospital districts and municipalities. We compared the normal and sensitive warfarin responder groups in terms of healthcare costs related to bleeding and thromboembolic events, INR tests and medication purchases. RESULTS: We found a trend towards increased bleeding-related hospital costs in the sensitive warfarin responder group (881 patients) when compared with the normal responders (1627 patients) with a per patient difference of 150.9 €/year (95% CI: -55.1, 414.6 €/year, p = 0.087). INR test costs were higher in the sensitive responder group with a difference of 7.2 €/year (95% CI: -1.5, 16.4 €/year, p = 0.047). Medication costs were significantly lower in the sensitive responder group with a difference of -14.4 €/year (95% CI: -15.8, -12.9 €/year, p < 0.001). CONCLUSIONS: The difference in the costs of bleeding-related hospitalization between genetically sensitive and normal warfarin responders may justify genotype-guided warfarin dosing. Further studies with larger sample sizes would be needed to verify the result.

Dietary fatty acid intake in childhood and the risk of islet autoimmunity and type 1 diabetes: the DIPP birth cohort study.

PURPOSE: The aim was to study the associations between dietary intake of fatty acids in childhood and the risk of islet autoimmunity and type 1 diabetes (T1D). METHODS: The prospective Finnish Type 1 Diabetes Prediction and Prevention (DIPP) Study included children with genetic susceptibility to T1D born between 1996 and 2004. Participants were followed up every 3 to 12 months up to 6 years for diet, islet autoantibodies, and T1D. Dietary intake of several fatty acids at the age of 3 months to 6 years was assessed 1-8 times per participant with a 3-day food record. Joint models adjusted for energy intake, sex, HLA genotype and familial diabetes were used to investigate the associations of longitudinal intake of fatty acids and the development of islet autoimmunity and T1D. RESULTS: During the 6-year follow-up, 247 (4.4%) children of 5626 developed islet autoimmunity and 94 (1.7%) children of 5674 developed T1D. Higher intake of monounsaturated fatty acids (HR 0.63; 95% CI 0.47, 0.82), arachidonic acid (0.69; 0.50, 0.94), total n-3 fatty acids (0.64; 0.48, 0.84), and long-chain n-3 fatty acids (0.14; 0.04, 0.43), was associated with a decreased risk of islet autoimmunity with and without energy adjustment. Higher intake of total fat (0.73; 0.53, 0.98), and saturated fatty acids (0.55; 0.33, 0.90) was associated with a decreased risk of T1D only when energy adjusted. CONCLUSION: Intake of several fatty acids was associated with a decreased risk of islet autoimmunity or T1D among high-risk children. Our findings support the idea that dietary factors, including n-3 fatty acids, may play a role in the disease process of T1D.

Association between CES1 rs2244613 and the pharmacokinetics and safety of dabigatran: Meta-analysis and quantitative trait loci analysis.

Objective: To date, the influence of the carboxylesterase 1 (CES1) rs2244613 genotype on the pharmacokinetics (PKs) and safety of dabigatran remains controversial. Hence, a systematic review was performed to study the association between CES1 rs2244613 genotype and the PKs and safety of dabigatran and CES1 relative expression. Methods: In addition to the three English databases (Web of Science, PubMed, and Embase), two Chinese databases (CNKI and Wanfang) were thoroughly revised. The mean differences (MD) and corresponding 95% confidence intervals (CI) were applied to evaluate the differences in PKs between the CES1 rs2244613 genotype. Odds ratio (OR) was used to study the risk for bleeding events between the CES1 rs2244613 genotypes. Subsequent expression quantitative trait loci (eQTL) analyses were performed to evaluate genotype-specific expressions in human tissues. Results: Ten studies (n = 2,777) were included. CES1 rs2244613 G allele carriers exhibited significantly lower dabigatran trough concentrations compared to T allele carriers (MD: -8.00 ng/mL; 95% CI: -15.08 to -0.92; p = 0.03). The risk for bleeding events was significantly lower in carriers of the G allele compared to T allele carriers (OR: 0.65; 95% CI: 0.44-0.96; p = 0.03). Subsequent eQTL analysis showed significant genome-wide expressions in two human tissues, whole blood (p = 5.1 × 10-10) and liver (p = 6.2 × 10-43). Conclusion: Our meta-analysis indicated a definite relation between the CES1 rs2244613 genotype and tolerability variations or pharmacokinetic fluctuations. The carriers of T allele showed higher dabigatran concentrations; therefore, they would benefit from a dose reduction. Systematic review registration: [https://inplasy.com/inplasy-2022-6-0027/], identifier [NPLASY202260027].

Integrating data from multiple Finnish biobanks and national health-care registers for retrospective studies: Practical experiences.

Aim: This case study aimed to investigate the process of integrating resources of multiple biobanks and health-care registers, especially addressing data permit application, time schedules, co-operation of stakeholders, data exchange and data quality. Methods: We investigated the process in the context of a retrospective study: Pharmacogenomics of antithrombotic drugs (PreMed study). The study involved linking the genotype data of three Finnish biobanks (Auria Biobank, Helsinki Biobank and THL Biobank) with register data on medicine dispensations, health-care encounters and laboratory results. Results: We managed to collect a cohort of 7005 genotyped individuals, thereby achieving the statistical power requirements of the study. The data collection process took 16 months, exceeding our original estimate by seven months. The main delays were caused by the congested data permit approval service to access national register data on health-care encounters. Comparison of hospital data lakes and national registers revealed differences, especially concerning medication data. Genetic variant frequencies were in line with earlier data reported for the European population. The yearly number of international normalised ratio (INR) tests showed stable behaviour over time. Conclusions: A large cohort, consisting of versatile individual-level phenotype and genotype data, can be constructed by integrating data from several biobanks and health data registers in Finland. Co-operation with biobanks is straightforward. However, long time periods need to be reserved when biobank resources are linked with national register data. There is a need for efforts to define general, harmonised co-operation practices and data exchange methods for enabling efficient collection of data from multiple sources.

A gamified mobile health intervention for children in day surgery care: Protocol for a randomized controlled trial.

AIMS: To describe a study protocol for a randomized controlled trial which will evaluate the effectiveness of a gamified mobile health intervention for children in whole day surgery care. DESIGN: A study protocol for a two-arm randomized controlled trial. METHODS: Participants will be randomly assigned to the intervention group (N = 62), in which patients receive routine care and play a mobile game designed for children or the control group (N = 62), in which patients receive routine care, including a mobile phone application that supports parents during the care path. The primary outcome is children's pre-operative anxiety, while the secondary outcome measures included fear and postoperative pain, along with parental satisfaction and anxiety. Data collection started in August 2020. RESULTS: The results of the ongoing randomized controlled trial will determine whether the developed gamified mobile health intervention can be recommended for hospital use, and whether it could be used to educate children about their surgical treatment to decrease anxiety.

Frequency of Self-Weighing and Weight Change: Cohort Study With 10,000 Smart Scale Users.

BACKGROUND: Frequent self-weighing is associated with successful weight loss and weight maintenance during and after weight loss interventions. Less is known about self-weighing behaviors and associated weight change in free-living settings. OBJECTIVE: This study aimed to investigate the association between the frequency of self-weighing and changes in body weight in a large international cohort of smart scale users. METHODS: This was an observational cohort study with 10,000 randomly selected smart scale users who had used the scale for at least 1 year. Longitudinal weight measurement data were analyzed. The association between the frequency of self-weighing and weight change over the follow-up was investigated among normal weight, overweight, and obese users using Pearson's correlation coefficient and linear models. The association between the frequency of self-weighing and temporal weight change was analyzed using linear mixed effects models. RESULTS: The eligible sample consisted of 9768 participants (6515/9768, 66.7% men; mean age 41.5 years; mean BMI 26.8 kg/m2). Of the participants, 4003 (4003/9768, 41.0%), 3748 (3748/9768, 38.4%), and 2017 (2017/9768, 20.6%) were normal weight, overweight, and obese, respectively. During the mean follow-up time of 1085 days, the mean weight change was -0.59 kg, and the mean percentage of days with a self-weigh was 39.98%, which equals 2.8 self-weighs per week. The percentage of self-weighing days correlated inversely with weight change, r=-0.111 (P<.001). Among normal weight, overweight, and obese individuals, the correlations were r=-0.100 (P<.001), r=-0.125 (P<.001), and r=-0.148 (P<.001), respectively. Of all participants, 72.5% (7085/9768) had at least one period of ≥30 days without weight measurements. During the break, weight increased, and weight gains were more pronounced among overweight and obese individuals: 0.58 kg in the normal weight group, 0.93 kg in the overweight group, and 1.37 kg in the obese group (P<.001). CONCLUSIONS: Frequent self-weighing was associated with favorable weight loss outcomes also in an uncontrolled, free-living setting, regardless of specific weight loss interventions. The beneficial associations of regular self-weighing were more pronounced for overweight or obese individuals.

Pharmacogenetics of Bleeding and Thromboembolic Events in Direct Oral Anticoagulant Users.

This study aimed to analyze associations between genetic variants and the occurrence of clinical outcomes in dabigatran, apixaban, and rivaroxaban users. This was a retrospective real-world study linking genotype data of three Finnish biobanks with national register data on drug dispensations and healthcare encounters. We investigated several single-nucleotide variants (SNVs) in the ABCG2, ABCB1, CES1, and CYP3A5 genes potentially associated with bleeding or thromboembolic events in direct oral anticoagulant (DOAC) users based on earlier research. We used Cox regression models to compare the incidence of clinical outcomes between carriers and noncarriers of the SNVs or haplotypes. In total, 1,806 patients on apixaban, dabigatran, or rivaroxaban were studied. The ABCB1 c.3435C>T (p.Ile1145=, rs1045642) SNV (hazard ratio (HR) 0.42, 95% confidence interval (CI), 0.18-0.98, P = 0.044) and 1236T-2677T-3435T (rs1128503-rs2032582-rs1045642) haplotype (HR 0.44, 95% CI, 0.20-0.95, P = 0.036) were associated with a reduced risk for thromboembolic outcomes, and the 1236C-2677G-3435C (HR 2.55, 95% CI, 1.03-6.36, P = 0.044) and 1236T-2677G-3435C (HR 5.88, 95% CI, 2.35-14.72, P < 0.001) haplotypes with an increased risk for thromboembolic outcomes in rivaroxaban users. The ABCB1 c.2482-2236G>A (rs4148738) SNV associated with a lower risk for bleeding events (HR 0.37, 95% CI, 0.16-0.89, P = 0.025) in apixaban users. ABCB1 variants are potential factors affecting thromboembolic events in rivaroxaban users and bleeding events in apixaban users. Studies with larger numbers of patients are warranted for comprehensive assessment of the pharmacogenetic associations of DOACs and their relevance for clinical practice.

Pharmacogenetics of Anticoagulation and Clinical Events in Warfarin-Treated Patients: A Register-Based Cohort Study with Biobank Data and National Health Registries in Finland.

PURPOSE: To assess the association between VKORC1 and CYP2C9 variants and the incidence of adverse drug reactions in warfarin-treated patients in a real-world setting. MATERIALS AND METHODS: This was a register-based cohort study (PreMed) linking data from Finnish biobanks, national health registries and patient records between January 1st 2007 and June 30th 2018. The inclusion criteria were: 1) ≥18 years of age, 2) CYP2C9 and VKORC1 genotype information available, 3) a diagnosis of a cardiovascular disease, 4) at least one warfarin purchase, 5) regular INR tests. Eligible individuals were divided into two warfarin sensitivity groups; normal responders, and sensitive and highly sensitive responders based on their VKORC1 and CYP2C9 genotypes. The incidences of clinical events were compared between the groups using Cox regression models. RESULTS: The cohort consisted of 2508 participants (45% women, mean age of 69 years), of whom 65% were categorized as normal responders and 35% sensitive or highly sensitive responders. Compared to normal responders, sensitive and highly sensitive responders had fewer INR tests below 2 (median: 33.3% vs 43.8%, 95% CI: -13.3%, -10.0%) and more above 3 (median: 18.2% vs 6.7%, 95% Cl: 8.3%, 10.8%). The incidence (per 100 patient-years) of bleeding outcomes was 5.4 for normal responders and 5.6 for the sensitive and highly sensitive responder group (HR=1.03, 95% CI: 0.74, 1.44). The incidence of thromboembolic outcomes was 4.9 and 7.8, respectively (HR=1.48, 95% CI: 1.08, 2.03). CONCLUSION: In a real-world setting, genetically sensitive and highly sensitive responders to warfarin had more high INR tests and required a lower daily dose of warfarin than normal responders. However, the risk for bleeding events was not increased in sensitive and highly sensitive responders. Interestingly, the risk of thromboembolic outcomes was lower in normal responders compared to the sensitive and highly sensitive responders. TRIAL REGISTRATION: NCT04001166.

Characterization and Correction of Bias Due to Nonparticipation and the Degree of Loyalty in Large-Scale Finnish Loyalty Card Data on Grocery Purchases: Cohort Study.

BACKGROUND: To date, the evaluation of diet has mostly been based on questionnaires and diaries that have their limitations in terms of being time and resource intensive, and a tendency toward social desirability. Loyalty card data obtained in retailing provides timely and objective information on diet-related behaviors. In Finland, the market is highly concentrated, which provides a unique opportunity to investigate diet through grocery purchases. OBJECTIVE: The aims of this study were as follows: (1) to investigate and quantify the selection bias in large-scale (n=47,066) loyalty card (LoCard) data and correct the bias by developing weighting schemes and (2) to investigate how the degree of loyalty relates to food purchases. METHODS: Members of a loyalty card program from a large retailer in Finland were contacted via email and invited to take part in the study, which involved consenting to the release of their grocery purchase data for research purposes. Participants' sociodemographic background was obtained through a web-based questionnaire and was compared to that of the general Finnish adult population obtained via Statistics Finland. To match the distributions of sociodemographic variables, poststratification weights were constructed by using the raking method. The degree of loyalty was self-estimated on a 5-point rating scale. RESULTS: On comparing our study sample with the general Finnish adult population, in our sample, there were more women (65.25%, 30,696/47,045 vs 51.12%, 2,273,139/4,446,869), individuals with higher education (56.91%, 20,684/36,348 vs 32.21%, 1,432,276/4,446,869), and employed individuals (60.53%, 22,086/36,487 vs 52.35%, 2,327,730/4,446,869). Additionally, in our sample, there was underrepresentation of individuals aged under 30 years (14.44%, 6,791/47,045 vs 18.04%, 802,295/4,446,869) and over 70 years (7.94%, 3,735/47,045 vs 18.20%, 809,317/4,446,869), as well as retired individuals (23.51%, 8,578/36,487 vs 31.82%, 1,414,785/4,446,869). Food purchases differed by the degree of loyalty, with higher shares of vegetable, red meat & processed meat, and fat spread purchases in the higher loyalty groups. CONCLUSIONS: Individuals who consented to the use of their loyalty card data for research purposes tended to diverge from the general Finnish adult population. However, the high volume of data enabled the inclusion of sociodemographically diverse subgroups and successful correction of the differences found in the distributions of sociodemographic variables. In addition, it seems that food purchases differ according to the degree of loyalty, which should be taken into account when researching loyalty card data. Despite the limitations, loyalty card data provide a cost-effective approach to reach large groups of people, including hard-to-reach population subgroups.

The digital patient journey solution for patients undergoing elective hip and knee arthroplasty: Protocol for a pragmatic randomized controlled trial.

AIM: To describe a randomized controlled trial (RCT) protocol that will evaluate the effectiveness of a digital patient journey (DPJ) solution in improving the outcomes of patients undergoing total hip and knee arthroplasty. BACKGROUND: There is an urgent need for novel technologies to ensure sustainability, improve patient experience, and empower patients in their own care by providing information, support, and control. DESIGN: A pragmatic RCT with two parallel arms. METHODS: The participants randomized assigned to the intervention arm (N = 33) will receive access to the DPJ solution. The participants in the control arm (N = 33) will receive conventional care, which is provided face to face by using paper-based methods. The group allocations will be blinded from the study nurse during the recruitment and baseline measures, as well as from the outcome assessors. Patients with total hip arthroplasty will be followed up for 8-12 weeks, whereas patients with total knee arthroplasty will be followed up for 6-8 weeks. The primary outcome is health-related quality of life, measured by the EuroQol EQ-5D-5L scale. Secondary outcomes include functional recovery, pain, patient experience, and self-efficacy. The first results are expected to be submitted for publication in 2020. IMPACT: This study will provide information on the health effects and cost benefits of using the DPJ solution to support a patient's preparation for surgery and postdischarge surgical care. If the DPJ solution is found to be effective, its implementation into clinical practice could lead to further improvements in patient outcomes. If the DPJ solution is found to be cost effective for the hospital, it could be used to improve hospital resource efficiency.

Correlation between symptoms and functioning in psychiatric patients and temporal patterns of medication refills derived from pharmacy prescription claims.

OBJECTIVES:: Pharmacy dispensing claims data provide longitudinal records of prescriptions and refill events. Previous studies in psychiatric patients have utilised these data to derive indicators of medication adherence based on information regarding the amount of medication supplied and its dosage. An alternative approach was developed in which the regularity of medication refill events was analysed as a potential indicator of psychiatric patient symptoms and functioning. METHODS:: A method to quantify the regularity of medication refills was developed and subsequently used to investigate how the resulting regularity index (RI), derived from retrospective prescription refill records, correlated with symptomatic and functional assessments of 89 psychiatric patients after adjusting for covariates. RESULTS:: A two-step hierarchical regression model indicated that variances explained by prior hospitalisation and the RI were significant for patient scores on the Kessler 10 Psychological Distress Scale (K10), standard beta value 0.22, p < 0.05, for the SF-12 MC, standard beta value -0.31, p < 0.01, and the Work and Social Adjustment Scale (WSAS), standard beta value 0.31, p < 0.01. CONCLUSIONS:: This method to quantify the regularity of medication refills using prescription supply date alone may provide valuable information about patients' symptoms and functioning.

Shifts in the Enjoyment of Healthy and Unhealthy Behaviors Affect Short- and Long-Term Postbariatric Weight Loss†.

Objective: To investigate whether bariatric patients experience changes in the enjoyment of health-promoting behaviors, and how those changes relate to weight loss success. Materials and Methods: Online lifestyle survey for bariatric patients ≥18 years old who had undergone gastric bypass or sleeve gastrectomy ≥1 year earlier. Changes in the enjoyment of eating behaviors and exercise were surveyed, and associations with weight loss success were analyzed. The role of obtaining external support since surgery was investigated. Results: Of 877 respondents, 475 were eligible (95% women, 53.3 ± 9.0 years, body mass index 34.2 ± 8.0 kg/m2), of whom 21%, 36%, and 43% had had surgery 12-24, 24-60, and >60 months earlier, respectively. Postsurgery, patients enjoyed eating healthy foods more (63%), exercise more (46%), eating junk food less (66%), and overeating less (95%). Increased enjoyment of healthy foods and exercise were only associated with weight loss success among patients with surgery ≥24 months previously. While obtaining external support was associated with successful weight loss overall, external support correlated with enjoying healthy food and exercise more in patients who had had their surgery at least 60 months previously. Discussion: Learning to enjoy health-promoting behaviors after bariatric surgery may not coincide with improved weight loss outcomes before 2 years have passed. † This article is a revised version of a previously published article that was withdrawn due to a large number of reporting and formatting errors. This version was published on June 26, 2018. For further details, see the official withdrawal notice at http://online.liebertpub.com/doi/full/10.1089/bari.2016.0036.withdraw or on page 94 in volume 13, number 2, 2018 of the Journal.

Telemonitoring and Mobile Phone-Based Health Coaching Among Finnish Diabetic and Heart Disease Patients: Randomized Controlled Trial.

BACKGROUND: There is a strong will and need to find alternative models of health care delivery driven by the ever-increasing burden of chronic diseases. OBJECTIVE: The purpose of this 1-year trial was to study whether a structured mobile phone-based health coaching program, which was supported by a remote monitoring system, could be used to improve the health-related quality of life (HRQL) and/or the clinical measures of type 2 diabetes and heart disease patients. METHODS: A randomized controlled trial was conducted among type 2 diabetes patients and heart disease patients of the South Karelia Social and Health Care District. Patients were recruited by sending invitations to randomly selected patients using the electronic health records system. Health coaches called patients every 4 to 6 weeks and patients were encouraged to self-monitor their weight, blood pressure, blood glucose (diabetics), and steps (heart disease patients) once per week. The primary outcome was HRQL measured by the Short Form (36) Health Survey (SF-36) and glycosylated hemoglobin (HbA1c) among diabetic patients. The clinical measures assessed were blood pressure, weight, waist circumference, and lipid levels. RESULTS: A total of 267 heart patients and 250 diabetes patients started in the trial, of which 246 and 225 patients concluded the end-point assessments, respectively. Withdrawal from the study was associated with the patients' unfamiliarity with mobile phones­of the 41 dropouts, 85% (11/13) of the heart disease patients and 88% (14/16) of the diabetes patients were familiar with mobile phones, whereas the corresponding percentages were 97.1% (231/238) and 98.6% (208/211), respectively, among the rest of the patients (P=.02 and P=.004). Withdrawal was also associated with heart disease patients' comorbidities­40% (8/20) of the dropouts had at least one comorbidity, whereas the corresponding percentage was 18.9% (47/249) among the rest of the patients (P=.02). The intervention showed no statistically significant benefits over the current practice with regard to health-related quality of life­heart disease patients: beta=0.730 (P=.36) for the physical component score and beta=-0.608 (P=.62) for the mental component score; diabetes patients: beta=0.875 (P=.85) for the physical component score and beta=-0.770 (P=.52) for the mental component score. There was a significant difference in waist circumference in the type 2 diabetes group (beta=-1.711, P=.01). There were no differences in any other outcome variables. CONCLUSIONS: A health coaching program supported with telemonitoring did not improve heart disease patients' or diabetes patients' quality of life or their clinical condition. There were indications that the intervention had a differential effect on heart patients and diabetes patients. Diabetes patients may be more prone to benefit from this kind of intervention. This should not be neglected when developing new ways for self-management of chronic diseases. TRIAL REGISTRATION: ClinicalTrials.gov NCT01310491; http://clinicaltrials.gov/ct2/show/NCT01310491 (Archived by WebCite at http://www.webcitation.org/6Z8l5FwAM).

Use of home telemonitoring to support multidisciplinary care of heart failure patients in Finland: randomized controlled trial.

BACKGROUND: Heart failure (HF) patients suffer from frequent and repeated hospitalizations, causing a substantial economic burden on society. Hospitalizations can be reduced considerably by better compliance with self-care. Home telemonitoring has the potential to boost patients' compliance with self-care, although the results are still contradictory. OBJECTIVE: A randomized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization. METHODS: HF patients were eligible whose left ventricular ejection fraction was lower than 35%, NYHA functional class ≥2, and who needed regular follow-up. Patients in the telemonitoring group (n=47) measured their body weight, blood pressure, and pulse and answered symptom-related questions on a weekly basis, reporting their values to the heart failure nurse using a mobile phone app. The heart failure nurse followed the status of patients weekly and if necessary contacted the patient. The primary outcome was the number of HF-related hospital days. Control patients (n=47) received multidisciplinary treatment according to standard practices. Patients' clinical status, use of health care resources, adherence, and user experience from the patients' and the health care professionals' perspective were studied. RESULTS: Adherence, calculated as a proportion of weekly submitted self-measurements, was close to 90%. No difference was found in the number of HF-related hospital days (incidence rate ratio [IRR]=0.812, P=.351), which was the primary outcome. The intervention group used more health care resources: they paid an increased number of visits to the nurse (IRR=1.73, P<.001), spent more time at the nurse reception (mean difference of 48.7 minutes, P<.001), and there was a greater number of telephone contacts between the nurse and intervention patients (IRR=3.82, P<.001 for nurse-induced contacts and IRR=1.63, P=.049 for patient-induced contacts). There were no statistically significant differences in patients' clinical health status or in their self-care behavior. The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the study. CONCLUSIONS: Home telemonitoring did not reduce the number of patients' HF-related hospital days and did not improve the patients' clinical condition. Patients in the telemonitoring group contacted the Cardiology Outpatient Clinic more frequently, and on this way increased the use of health care resources. TRIAL REGISTRATION: Clinicaltrials.gov NCT01759368; http://clinicaltrials.gov/show/NCT01759368 (Archived by WebCite at http://www.webcitation.org/6UFxiCk8Z).

Are breaks in daily self-weighing associated with weight gain?

Regular self-weighing is linked to successful weight loss and maintenance. However, an individual's self-weighing frequency typically varies over time. This study examined temporal associations between time differences of consecutive weight measurements and the corresponding weight changes by analysing longitudinal self-weighing data, including 2,838 weight observations from 40 individuals attending a health-promoting programme. The relationship between temporal weighing frequency and corresponding weight change was studied primarily using a linear mixed effects model. Weight change between consecutive weight measurements was associated with the corresponding time difference (ß = 0.021% per day, p<0.001). Weight loss took place during periods of daily self-weighing, whereas breaks longer than one month posed a risk of weight gain. The findings emphasize that missing data in weight management studies with a weight-monitoring component may be associated with non-adherence to the weight loss programme and an early sign of weight gain.