In a cluster-randomized trial, Riitta Luoto and colleagues find that counseling on diet and activity can reduce the birthweight of babies born to women at risk of developing gestational diabetes mellitus (GDM), but fail to find an effect on GDM.

BackgroundRegistered 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.MethodsWe 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.ResultsWe 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.ConclusionsExercise 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 registrationClinicalTrials.gov, NCT01465698 November 7, 2011 (prospective).Electronic supplementary materialThe online version of this article (10.1186/s12889-018-6293-9) contains supplementary material, which is available to authorized users.

BackgroundAnnual 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/DesignA 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 ≥ 25 kg/m2, history of earlier gestational glucose intolerance or macrosomic newborn (> 4500 g), age ≥ 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.DiscussionThe 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 registrationThe trial is registered ISRCTN 33885819

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.

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.