Neuromuscular exercise and counseling for treating recurrent low back pain in female healthcare workers-Findings from a 24-month follow-up study of a randomized controlled trial.

BACKGROUND: Female healthcare workers have a high prevalence of low back pain (LBP)-related sickness absence. Here, we report findings of a 24-month follow-up of a previously published 6-month randomized controlled trial (RCT). METHODS: By adopting an RCT with 6 months of intervention and follow-up at 6, 12, and 24 months, we assessed the maintenance of changes in the effectiveness (LBP and fear of pain) of the interventions (neuromuscular exercise [NME], back-care counseling, both combined) using a generalized linear mixed model adjusted for baseline covariates. The incremental cost-effectiveness ratio was calculated in terms of quality-adjusted life years (QALY). A bootstrap technique was used to estimate the uncertainty around a cost-effectiveness acceptability curve. RESULTS: Of the 219 females, 71% had data at 24 months. Between 6 and 24 months, LBP intensity (primary outcome) remained low in all intervention arms (-20% to -48%) compared to the control (-10% to -16%). Pain interfering with work remained low in the combined and exercise arms for up to 24 months. At 24 months, the total costs were lowest in the combined arm (€484 vs. €613-948, p < 0.001), as were the number of back-related sickness absence days (0.16 vs. 1.14-3.26, p = 0.003). The analysis indicated a 95% probability of the combined arm to be cost-effective per QALY gained at €1120. CONCLUSIONS: Six months of weekly NME combined with four counseling sessions was cost-effective for treating LBP and the effect was maintained over 24 months. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01465698, 7/11/2011, prospective.

Economic burden of low physical activity and high sedentary behaviour in Finland.

BACKGROUND: Low physical activity and high sedentary behaviour are unquestionably relevant for public health while also increasing direct and indirect costs. METHODS: The authors examined the direct and indirect costs attributable to low physical activity and high sedentary behaviour in Finland in 2017. Costs related to major non-communicable diseases drawn from Finnish registries covered direct costs (outpatient visits, days of inpatient care, medication and institutional eldercare) and indirect costs (sickness-related absences, disability pensions, unemployment benefits, all-cause mortality and losses of income tax revenue). Prevalences of low physical activity and high sedentary behaviour (≥8 hours per 16 waking hours) were based on self-reports among adolescents or accelerometer data among adults and the elderly from three Finnish population studies: FINFIT 2017, Health 2011 and the Cardiovascular Risk in Young Finns Study. Cost calculations used adjusted population attributable fractions (PAF) and regression models. Total annual costs were obtained by multiplying PAF by the total costs of the given disease. RESULTS: The total costs of low physical activity in Finland in 2017 came to approximately €3.2 billion, of which direct costs accounted for €683 million and indirect ones for €2.5 billion. Costs attributable to high sedentary behaviour totalled roughly €1.5 billion. CONCLUSION: The findings suggest that low physical activity and high sedentary behaviour levels create substantial societal costs. Therefore, actions intended to increase physical activity and reduce excessive sedentary behaviour throughout life may yield not only better health but also considerable savings to society.

Effectiveness and cost-effectiveness of neuromuscular exercise and back care counseling in female healthcare workers with recurrent non-specific low back pain: a blinded four-arm randomized controlled trial.

BACKGROUND: Registered healthcare workers worldwide have a high prevalence of work-related musculoskeletal disorders, particularly of the back. Multidisciplinary interventions among these workers have improved fear avoidance beliefs, but not low back pain (LBP) and related sickness absences, cost-effectiveness studies are scarce. Our purpose was to investigate the effectiveness and cost-effectiveness of three intervention-arms (combined neuromuscular exercise and back care counselling or either alone) compared with non-treatment. METHODS: We randomly assigned female healthcare workers with recurrent non-specific LBP to one of four study-arms: Combined neuromuscular exercise and back care counseling; Exercise; Counseling; and no intervention Control. We assessed the effectiveness of the interventions on intensity of LBP, pain interfering with work and fear avoidance beliefs against the Control, and calculated the incremental cost-effectiveness ratios for sickness absence and QALY. RESULTS: We conducted three sub-studies in consecutive years of 2011, 2012, and 2013 to reach an adequate sample size. All together 219 women were randomized within each sub-study, of whom 74 and 68% had adequate questionnaire data at 6 and 12 months, respectively. No adverse events occurred. Compliance rates varied between intervention-arms. After 12 months, the Combined-arm showed reduced intensity of LBP (p = 0.006; effect size 0.70, confidence interval 0.23 to 1.17) and pain interfering with work (p = 0.011) compared with the Control-arm. Work-related fear of pain was reduced in both the Combined- (p = 0.003) and Exercise-arm (p = 0.002). Physical activity-related fear was reduced only in the Exercise-arm (p = 0.008). During the study period (0-12 months) mean total costs were lowest in the Combined-arm (€476 vs. €1062-€1992, p < 0.001) as were the mean number of sickness absence days (0.15 vs. 2.29-4.17, p = 0.025). None of the intervention-arms was cost-effective for sickness absence. There was 85% probability of exercise-arm being cost-effective if willing to pay €3550 for QALY gained. CONCLUSIONS: Exercise once a week for 6 months combined with five sessions of back care counseling after working hours in real-life settings effectively reduced the intensity of LBP, work interference due to LBP, and fear of pain, but was not cost-effective. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01465698 November 7, 2011 (prospective).

Metabolic syndrome in Finnish women 7†years after a gestational diabetes prevention trial.

BACKGROUND: Risk for developing metabolic syndrome (MeS) after delivery is high among women with gestational diabetes mellitus (GDM), but little is known about development of MeS among women with risk factors for GDM during pregnancy. In the present study, we studied the prevalence of MeS 7 years postpartum among women with GDM risk factors during pregnancy, women with early GDM diagnosis and women without GDM risk factors. We also analysed the early pregnancy risk factors associated with MeS. METHODS: A Finnish cluster randomised controlled GDM prevention trial was conducted in 2007-2009. The prevalence of MeS according to International Diabetes Federation criteria was determined in the follow-up study 7 years after original trial. Eligible participants (n=289) in 4 study groups (intervention (n=83) and usual care (n=87) with GDM risk factors; early GDM (n=51), and healthy control without GDM risk factors (n=68)) were evaluated for MeS. Binary logistic regression models were used to analyse risk factors associated with MeS. RESULTS: 7 years postpartum, the MeS prevalence was 14% (95% CI 8% to 25%) in the intervention group; 15% (CI 8% to 25%) in the usual care group; 50% (CI 35% to 65%) in the early GDM group and 7% (CI 2% to 18%) in the healthy control group. OR for MeS in women with GDM risk factors did not differ from the healthy control group. Body mass index (BMI)-adjusted OR for MeS was 9.18 (CI 1.82 to 46.20) in the early GDM group compared with the healthy control group. Increased prepregnancy BMI was associated with MeS (OR, 1.17, CI 1.08 to 1.28, adjusted for group). CONCLUSIONS: Increased prepregnancy BMI and early GDM diagnosis were the strongest risk factors for developing MeS 7 years postpartum. Overweight and obese women and especially those with early GDM should be monitored and counselled for cardiometabolic risk factors after delivery.

Evaluation of the Effects of Physical Activity, Cardiorespiratory Condition, and Neuromuscular Fitness on Direct Healthcare Costs and Sickness-Related Absence Among Nursing Personnel With Recurrent Nonspecific Low Back Pain.

STUDY DESIGN: A cross-sectional study, part of a randomized controlled trial. OBJECTIVE: To evaluate the association of physical activity, cardiorespiratory fitness, and neuromuscular fitness with direct healthcare costs and sickness-related absence among nursing personnel with nonspecific low back pain. SUMMARY OF BACKGROUND DATA: Low back pain creates a huge economic burden due to increased sick leave and use of healthcare services. METHODS: Female nursing personnel with nonspecific low back pain were included (n = 219). Physical activity was assessed with accelerometry and a questionnaire. In addition, measurements of cardiorespiratory and muscular fitness were conducted. Direct costs and sickness-related absence for a 6-month period were collected retrospectively by questionnaire. Health care utilization and absence from work were analyzed with a general linear model. RESULTS: The mean total costs were 80.5% lower among women who met physical activity recommendations than inactive women. Those with a higher mean daily intensity level of 10-minute activity sessions showed lower total costs than women in the lowest tertile (middle: 64.0% of the lowest; highest: 54.3% of the lowest). Women with good cardiorespiratory fitness (the highest tertile) as measured with the 6-minute-walk test (based on walking distance) had 77.0% lower total costs when compared with the lowest tertile. Women in the highest third for the modified push-up test had 84.0% lower total costs than those with the poorest results (the bottom tertile). CONCLUSION: High cardiorespiratory and muscular fitness and meeting physical activity recommendations for aerobic and muscular fitness were strongly associated with lower total costs among nursing personnel with pain-related disorders of recurrent nonspecific low back pain. Actions to increase physical activity and muscle conditioning may significantly save on healthcare costs and decrease sick-leave costs due to low back pain.

Effectiveness and Cost-Effectiveness of a Cluster-Randomized Prenatal Lifestyle Counseling Trial: A Seven-Year Follow-Up.

There is a link between the pregnancy and its long-term influence on health and susceptibility to future chronic disease both in mother and offspring. The objective was to determine whether individual counseling on physical activity and diet and weight gain at five antenatal visits can prevent type 2 diabetes mellitus (T2DM) and overweight or improve glycemic parameters, among all at-risk-mothers and their children. Another objective was to evaluate whether gestational lifestyle intervention was cost-effective as measured with mother's sickness absence and quality-adjusted life years (QALY). This study was a seven-year follow-up study for women, who were enrolled to the antenatal cluster-randomized controlled trial (RCT). Analysis of the outcome included all women whose outcome was available, in addition with subgroup analysis including women adherent to all lifestyle aims. A total of 173 women with their children participated to the study, representing 43% (173/399) of the women who finished the original RCT. Main outcome measures were: T2DM based on medication use or fasting blood glucose or oral glucose tolerance test (OGTT), body mass index (BMI), glycosylated hemoglobin (HbA1c). None of the women were diagnosed to have T2DM. HbA1c or fasting blood glucose differences were not found among mothers or children. Differences in BMI were non-significant among mothers (Intervention 27.3, Usual care 28.1 kg/m2, p = 0.33) and children (I 21.3 vs U 22.5 kg/m2, p = 0.07). Children's BMI was significantly lower among adherent group (I 20.5 vs U 22.5, p = 0.04). The mean total cost per person was 30.6% lower in the intervention group than in the usual care group (I €2,944 vs. U €4,243; p = 0.74). Intervention was cost-effective in terms of sickness absence but not in QALY gained i.e. if society is willing to pay additional €100 per one avoided sickness absence day; there is a 90% probability of the intervention arm to be cost-effective. Long-term effectiveness of antenatal lifestyle counseling was not shown, in spite of possible effect on children's BMI. Cost-effectiveness of the intervention in terms of sickness absence may have larger societal impact.

Cost-effectiveness of physical activity among women with menopause symptoms: findings from a randomised controlled trial.

Menopause is a period that may predispose one to a decrease in muscle strength, cardiorespiratory fitness, and quality of life. A study was carried out to evaluate the cost-effectiveness of physical activity among women displaying symptoms of menopause. The cost-effectiveness analysis was based on data from a six-month randomised controlled trial (n = 151). The women in the intervention group engaged in an unsupervised session of at least 50 minutes of physical activity four times a week. The control group continued their physical activity as before. An incremental cost-effectiveness ratio (ICER) was calculated in terms of maximal oxygen consumption, lean muscle mass, and quality-adjusted life years (QALYs) gained. A bootstrap technique was utilised to estimate uncertainty around the point estimate for ICER associated with the intervention. The mean total cost in the intervention group was €1,307 (SEM: €311) and in the control group was €1,253 (SEM: €279, p = 0.10) per person. The mean intervention cost was €208 per person. After six months of the behaviour-change intervention, the ICER was €63 for a 1 ml/kg/min improvement in cardiorespiratory fitness, the additional cost per one-gram increase in lean muscle mass was €126, and the cost per QALY gained was €46. According to the findings, physical activity among menopausal women was cost-effective for cardiorespiratory fitness, for lean muscle mass, and for QALYs gained, since the intervention was more effective than the actions within the control group and the additional effects of physical activity were gained at a very low price. From the societal perspective, the intervention used may promote ability to work and thereby save on further costs associated with early retirement or disability pension if the physical-activity level remains at least the same as during the intervention.

Physical activity and health-related quality of life during pregnancy: a secondary analysis of a cluster-randomised trial.

The aim of the study was to evaluate the role of physical activity before and during pregnancy on health-related quality of life (HRQoL). Data from the cluster-randomised gestational diabetes mellitus primary prevention trial conducted in maternity clinics were utilised in a secondary analysis. The cases considered were pregnant women who reported engaging in at least 150 min of moderate-intensity leisure-time physical activity per week (active women) (N = 80), and the controls were women below these recommendations (less active) (N = 258). All participants had at least one risk factor for gestational diabetes mellitus. Their HRQoL was evaluated via the validated generic instrument 15D, with HRQoL at the end of pregnancy examined in relation to changes in physical activity during pregnancy. Logistic regression models addressed age, parity, education, and pre-pregnancy body mass index. At the end of pregnancy, the expected HRQoL was higher (tobit regression coefficient 0.022, 95 % CI 0.003-0.042) among active women than less active women. Active women also had greater mobility (OR 1.98, 95 % CI 1.04-3.78), ability to handle their usual activities (OR 2.22, 95 % CI 1.29-3.81), and vitality (OR 2.08, 95 % CI 1.22-3.54) than did less active women. Active women reported higher-quality sleep (OR 2.11, 95 % CI 1.03-4.30) throughout pregnancy as compared to less active women. Meeting of the physical activity guidelines before pregnancy was associated with better overall HRQoL and components thereof related to physical activity.

Cost-effectiveness of lifestyle counselling as primary prevention of gestational diabetes mellitus: findings from a cluster-randomised trial.

AIMS: The aim was to evaluate the cost-effectiveness of primary prevention of gestational diabetes mellitus (GDM) through intensified counselling on physical activity, diet, and appropriate weight gain among the risk group. MATERIALS AND METHODS: The cost-effectiveness analysis was based on data from a cluster-randomised controlled GDM prevention trial carried out in primary health-care maternity clinics in Finland. Women (n = 399) with at least one risk factor for GDM were included. The incremental cost-effectiveness ratio (ICER) was calculated in terms of birth weight, 15D, and perceived health as measured with a visual analogue scale (VAS). A bootstrap technique for cluster-randomised samples was used to estimate uncertainty around a cost-effectiveness acceptability curve. RESULTS: The mean total cost in the intervention group was €7,763 (standard deviation (SD): €4,511) and in the usual-care group was €6,994 (SD: €4,326, p = 0.14). The mean intervention cost was €141. The difference for costs in the birth-weight group was €753 (95% CI: -250 to 1,818) and in effects for birth weight was 115 g (95% CI: 15 to 222). The ICER for birth weight was almost €7, with 86.7% of bootstrap pairs located in the north-east quadrant, indicating that the intervention was more effective and more expensive in birth weight terms than the usual care was. The data show an 86.7% probability that each gram of birth weight avoided requires an additional cost of €7. CONCLUSIONS: Intervention was effective for birth weight but was not cost-effective for birth weight, 15D, or VAS when compared to the usual care. TRIAL REGISTRATION: ISRCTN 33885819.

Is intensive counseling in maternity care feasible and effective in promoting physical activity among women at risk for gestational diabetes? Secondary analysis of a cluster randomized NELLI study in Finland.

BACKGROUND: Women who are physically active during early pregnancy have notably lower odds of developing gestational diabetes than do inactive women. The purpose of the intervention was to examine whether intensified physical activity (PA) counseling in Finnish maternity care is feasible and effective in promoting leisure-time PA (LTPA) among pregnant women at risk of gestational diabetes. METHODS: Fourteen municipalities were randomized to intervention (INT) and usual care group (UC). Nurses in INT integrated five PA counseling sessions into routine maternity visits and offered monthly group meetings on PA instructed by physiotherapists. In UC conventional practices were continued. Feasibility evaluation included safety (incidence of PA-related adverse events; questionnaire), realization (timing and duration of sessions, number of sessions missed, attendance at group meetings; systematic record-keeping of the nurses and physiotherapists) and applicability (nurses' views; telephone interview). Effectiveness outcomes were weekly frequency and duration of total and intensity-specific LTPA and meeting PA recommendation for health self-reported at 8-12 (baseline), 26-28 and 36-37 weeks' gestation. Multilevel analysis with adjustments was used in testing for between-group differences in PA changes. RESULTS: The decrease in the weekly days of total and moderate-to-vigorous-intensity LTPA was smaller in INT (N = 219) than in UC (N = 180) from baseline to the first follow-up (0.1 vs. -1.2, p = 0.040 and -0.2 vs. -1.3, p = 0.016). A similar trend was seen in meeting the PA recommendation (-11%-points vs. -28%-points, p = 0.06). INT did not experience more adverse events classified as warning signs to terminate exercise than UC, counseling was implemented as planned and viewed positively by the nurses. CONCLUSIONS: Intensified counseling had no effects on the duration of total or intensity-specific weekly LTPA. However, it was able to reduce the decrease in the weekly frequency of total and moderate-to-vigorous-intensity LTPA from baseline to the end of second trimester and was feasibly embedded into routine practices. TR

Health care costs associated with gestational diabetes mellitus among high-risk women--results from a randomised trial.

BACKGROUND: The costs of gestational diabetes mellitus (GDM) screening have been frequently reported, but total GDM-related health care costs compared to the health care costs of women without GDM have not been reported. The aim of this study was to analyse GDM-related health care costs among women with an elevated risk of GDM. METHODS: The study was based on a cluster-randomised GDM prevention trial (N = 848) carried out at maternity clinics, combined with data from the Finnish Medical Birth Register and Care Registers for Social Welfare and Health Care. Costs of outpatient visits to primary and secondary care, cost of inpatient hospital care before and after delivery, the use of insulin, delivery costs and babies' stay in the neonatal intensive care unit were analysed. Women who developed GDM were compared to those who were not diagnosed with GDM. RESULTS: Total mean health care costs adjusted for age, body mass index and education were 25.1% higher among women diagnosed with GDM (€6,432 vs. €5,143, p < 0.001) than among women without GDM. The cost of inpatient visits was 44% higher and neonatal intensive care unit use was 49% higher in the GDM group than among women without GDM. The delivery costs were the largest single component in both groups. CONCLUSIONS: A confirmed GDM diagnosis was associated with a significant increase in total health care costs. Effective lifestyle counselling by primary health care providers may offer a means of reducing the high costs of secondary care.

Primary prevention of gestational diabetes mellitus and large-for-gestational-age newborns by lifestyle counseling: a cluster-randomized controlled trial.

BACKGROUND: Our objective was to examine whether gestational diabetes mellitus (GDM) or newborns' high birthweight can be prevented by lifestyle counseling in pregnant women at high risk of GDM. METHOD AND FINDINGS: We conducted a cluster-randomized trial, the NELLI study, in 14 municipalities in Finland, where 2,271 women were screened by oral glucose tolerance test (OGTT) at 8-12 wk gestation. Euglycemic (n = 399) women with at least one GDM risk factor (body mass index [BMI] ≥ 25 kg/m(2), glucose intolerance or newborn's macrosomia (≥ 4,500 g) in any earlier pregnancy, family history of diabetes, age ≥ 40 y) were included. The intervention included individual intensified counseling on physical activity and diet and weight gain at five antenatal visits. Primary outcomes were incidence of GDM as assessed by OGTT (maternal outcome) and newborns' birthweight adjusted for gestational age (neonatal outcome). Secondary outcomes were maternal weight gain and the need for insulin treatment during pregnancy. Adherence to the intervention was evaluated on the basis of changes in physical activity (weekly metabolic equivalent task (MET) minutes) and diet (intake of total fat, saturated and polyunsaturated fatty acids, saccharose, and fiber). Multilevel analyses took into account cluster, maternity clinic, and nurse level influences in addition to age, education, parity, and prepregnancy BMI. 15.8% (34/216) of women in the intervention group and 12.4% (22/179) in the usual care group developed GDM (absolute effect size 1.36, 95% confidence interval [CI] 0.71-2.62, p = 0.36). Neonatal birthweight was lower in the intervention than in the usual care group (absolute effect size -133 g, 95% CI -231 to -35, p = 0.008) as was proportion of large-for-gestational-age (LGA) newborns (26/216, 12.1% versus 34/179, 19.7%, p = 0.042). Women in the intervention group increased their intake of dietary fiber (adjusted coefficient 1.83, 95% CI 0.30-3.25, p = 0.023) and polyunsaturated fatty acids (adjusted coefficient 0.37, 95% CI 0.16-0.57, p < 0.001), decreased their intake of saturated fatty acids (adjusted coefficient -0.63, 95% CI -1.12 to -0.15, p = 0.01) and intake of saccharose (adjusted coefficient -0.83, 95% CI -1.55 to -0.11, p  =  0.023), and had a tendency to a smaller decrease in MET minutes/week for at least moderate intensity activity (adjusted coefficient 91, 95% CI -37 to 219, p = 0.17) than women in the usual care group. In subgroup analysis, adherent women in the intervention group (n = 55/229) had decreased risk of GDM (27.3% versus 33.0%, p = 0.43) and LGA newborns (7.3% versus 19.5%, p = 0.03) compared to women in the usual care group. CONCLUSIONS: The intervention was effective in controlling birthweight of the newborns, but failed to have an effect on maternal GDM. TRIAL REGISTRATION: Current Controlled Trials ISRCTN33885819. Please see later in the article for the Editors' Summary.

Cost of gestational diabetes-related antenatal visits in health care based on the Finnish Medical Birth Register.

The aim was to evaluate frequency and costs of antenatal health care visits related to risk of gestational diabetes (GDM) using Birth Register. Costs among all GDM risk groups were 10-41% larger than non-risk groups. Primary health care is needed to reduce special health care costs related to GDM.

Prevention of gestational diabetes: design of a cluster-randomized controlled trial and one-year follow-up.

BACKGROUND: Annual prevalence of gestational diabetes mellitus (GDM) is 12.5% among Finnish pregnant women. The prevalence is expected to rise with the increasing overweight among women before pregnancy. Physical activity and diet are both known to have favourable effects on insulin resistance and possibly on the risk of GDM. We aimed to investigate, whether GDM can be prevented by counseling on diet, physical activity and gestational weight gain during pregnancy. METHODS/DESIGN: A cluster-randomized controlled trial was conducted in 14 municipalities in the southern part of Finland. Pairwise randomization was performed in order to take into account socioeconomic differences. Recruited women were at 8-12 weeks' gestation and fulfilled at least one of the following criteria: body mass index>or=25 kg/m2, history of earlier gestational glucose intolerance or macrosomic newborn (>4500 g), age>or=40 years, first or second degree relative with history of type 1 or 2 diabetes. Main exclusion criterion was pathological oral glucose tolerance test (OGTT) at 8-12 weeks' gestation. The trial included one counseling session on physical activity at 8-12 weeks' gestation and one for diet at 16-18 weeks' gestation, and three to four booster sessions during other routine visits. In the control clinics women received usual care. Information on height, weight gain and other gestational factors was obtained from maternity cards. Physical activity, dietary intake and quality of life were followed by questionnaires during pregnancy and at 1-year postpartum. Blood samples for lipid status, hormones, insulin and OGTT were taken at 8-12 and 26-28 weeks' gestation and 1 year postpartum. Workability and return to work were elicited by a questionnaire at 1- year postpartum. Linkage to the national birth register of years 2007-2009 will provide information on perinatal complications and GDM incidence among the non-participants of the study. Cost-effectiveness evaluation will be based on quality-adjusted life years. This study has received ethical approval from the Ethical board of Pirkanmaa Hospital District. DISCUSSION: The study will provide information on the effectiveness and cost-effectiveness of gestational physical activity and dietary counseling on prevention of GDM in a risk group of women. Also information on the prevalence of GDM and postpartum metabolic syndrome will be gained. Results on maintaining the possible health behaviour changes are important in order to prevent chronic diseases such as cardiovascular disease and diabetes. TRIAL REGISTRATION: The trial is registered ISRCTN 33885819.