Is a motivational interviewing based lifestyle intervention for obese pregnant women across Europe implemented as planned? Process evaluation of the DALI study

Background: Process evaluation is an essential part of designing and assessing complex interventions. The vitamin D and lifestyle intervention study (DALI) study is testing different strategies to prevent development of gestational diabetes mellitus among European obese pregnant women with a body mass index ≥29kg/m2. The intervention includes guidance on physical activity and/or healthy eating by a lifestyle coach trained in motivational interviewing (MI). The aim of this study was to assess the process elements: reach, dose delivered, fidelity and satisfaction and to investigate whether these process elements were associated with changes in gestational weight gain (GWG). Methods: Data on reach, dose delivered, fidelity, and satisfaction among 144 participants were collected. Weekly recruitment reports, notes from meetings, coach logs and evaluation questionnaires (n=110) were consulted. Fidelity of eight (out of twelve) lifestyle coach practitioners was assessed by analysing audio recorded counselling sessions using the MI treatment integrity scale. Furthermore, associations between process elements and GWG were assessed with linear regression analyses. Results: A total of 20% of the possible study population (reach) was included in this analysis. On average 4.0 (of the intended 5) face-to-face sessions were delivered. Mean MI fidelity almost reached \u27expert opinion\u27 threshold for the global scores, but was below \u27beginning proficiency\u27 for the behavioural counts. High variability in quality of MI between practitioners was identified. Participants were highly satisfied with the intervention, the lifestyle coach and the intervention materials. No significant associations were found between process elements and GWG. Conclusion: Overall, the intervention was well delivered and received by the study population, but did not comply with all the principles of MI. Ensuring audio recording of lifestyle sessions throughout the study would facilitate provision of individualized feedback to improve MI skills. A larger sample size is needed to confirm the lack of association between process elements and GWG. Trial registration: ISRCTN registry: ISRCTN70595832 ; Registered 12 December 2011

Cost-effectiveness of healthy eating and/or physical activity promotion in pregnant women at increased risk of gestational diabetes mellitus: Economic evaluation alongside the DALI study, a European multicenter randomized controlled trial

Background: Gestational diabetes mellitus (GDM) is associated with perinatal health risks to both mother and offspring, and represents a large economic burden. The DALI study is a multicenter randomized controlled trial, undertaken to add to the knowledge base on the effectiveness of interventions for pregnant women at increased risk for GDM. The purpose of this study was to evaluate the cost-effectiveness of the healthy eating and/or physical activity promotion intervention compared to usual care among pregnant women at increased risk of GDM from a societal perspective. Methods: An economic evaluation was performed alongside a European multicenter-randomized controlled trial. A total of 435 pregnant women at increased risk of GDM in primary and secondary care settings in nine European countries, were recruited and randomly allocated to a healthy eating and physical activity promotion intervention (HE + PA intervention), a healthy eating promotion intervention (HE intervention), or a physical activity promotion intervention (PA intervention). Main outcome measures were gestational weight gain, fasting glucose, insulin resistance (HOMA-IR), quality adjusted life years (QALYs), and societal costs. Results: Between-group total cost and effect differences were not significant, besides significantly less gestational weight gain in the HE + PA group compared with the usual care group at 35-37 weeks ( 2.3;95%CI:-3.7;-0.9). Cost-effectiveness acceptability curves indicated that the HE + PA intervention was the preferred intervention strategy. At 35-37 weeks, it depends on the decision-makers\u27 willingness to pay per kilogram reduction in gestational weight gain whether the HE + PA intervention is cost-effective for gestational weight gain, whereas it was not cost-effective for fasting glucose and HOMA-IR. After delivery, the HE + PA intervention was cost-effective for QALYs, which was predominantly caused by a large reduction in delivery-related costs. Conclusions: Healthy eating and physical activity promotion was found to be the preferred strategy for limiting gestational weight gain. As this intervention was cost-effective for QALYs after delivery, this study lends support for broad implementation

A reduction in sedentary behaviour in obese women during pregnancy reduces neonatal adiposity: the DALI randomised controlled trial

Aims/hypothesis: Offspring of obese women are at increased risk of features of the metabolic syndrome, including obesity and diabetes. Lifestyle intervention in pregnancy might reduce adverse effects of maternal obesity on neonatal adiposity. Methods: In the Vitamin D And Lifestyle Intervention for Gestational Diabetes Mellitus (GDM) Prevention (DALI) lifestyle trial, 436 women with a BMI ≥29 kg/m2 were randomly assigned to counselling on healthy eating (HE), physical activity (PA) or HE&PA, or to usual care (UC). In secondary analyses of the lifestyle trial, intervention effects on neonatal outcomes (head, abdominal, arm and leg circumferences and skinfold thicknesses, estimated fat mass, fat percentage, fat-free mass and cord blood leptin) were assessed using multilevel regression analyses. Mediation of intervention effects by lifestyle and gestational weight gain was assessed. Results: Outcomes were available from 334 neonates. A reduction in sum of skinfolds (−1.8 mm; 95% CI −3.5, −0.2; p = 0.03), fat mass (−63 g; 95% CI −124, −2; p = 0.04), fat percentage (−1.2%; 95% CI −2.4%, −0.04%; p = 0.04) and leptin (−3.80 μg/l; 95% CI −7.15, −0.45; p = 0.03) was found in the HE&PA group, and reduced leptin in female neonates in the PA group (−5.79 μg/l; 95% CI −11.43, −0.14; p = 0.05) compared with UC. Reduced sedentary time, but not gestational weight gain, mediated intervention effects on leptin in both the HE&PA and PA groups. Conclusions/interpretation: The HE&PA intervention resulted in reduced adiposity in neonates. Reduced sedentary time seemed to drive the intervention effect on cord blood leptin. Implications for future adiposity and diabetes risk of the offspring need to be elucidated. Trial registration: ISRCTN70595832

AURORA : bariatric surgery registration in women of reproductive age : a multicenter prospective cohort study

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AURORA : bariatric surgery registration in women of reproductive age : a multicenter prospective cohort study

Background: The expansion of the obesity epidemic is accompanied with an increase in bariatric procedures, in particular in women of reproductive age. The weight loss induced by the surgery is believed to reverse the negative impact of overweight and obesity on female reproduction, however, research is limited to in particular retrospective cohort studies and a growing number of small case-series and case-(control) studies. Methods/design: AURORA is a multicenter prospective cohort study. The main objective is to collect long-term data on reproductive outcomes before and after bariatric surgery and in a subsequent pregnancy. Women aged 18-45 years are invited to participate at 4 possible inclusion moments: 1) before surgery, 2) after surgery, 3) before 15 weeks of pregnancy and 4) in the immediate postpartum period (day 3-4). Depending on the time of inclusion, data are collected before surgery (T1), 3 weeks and 3, 6, 12 or x months after surgery (T2-T5) and during the first, second and third trimester of pregnancy (T6-T8), at delivery (T9) and 6 weeks and 6 months after delivery (T10-T11). Online questionnaires are send on the different measuring moments. Data are collected on contraception, menstrual cycle, sexuality, intention of becoming pregnant, diet, physical activity, lifestyle, psycho-social characteristics and dietary supplement intake. Fasting blood samples determine levels of vitamin A, D, E, K, B-1, B-12 and folate, albumin, total protein, coagulation parameters, magnesium, calcium, zinc and glucose. Participants are weighted every measuring moment. Fetal ultrasounds and pregnancy course and complications are reported every trimester of pregnancy. Breastfeeding is recorded and breast milk composition in the postpartum period is studied. Discussion: AURORA is a multicenter prospective cohort study extensively monitoring women before undergoing bariatric surgery until a subsequent pregnancy and postpartum period

Traumapotilaan golden hour Kainuun ensihoidossa : Tutkimus traumapotilaan golden hour:n toteutumisesta sekä siihen vaikuttavista tekijöistä Kainuun ensihoidossa

Tutkimuksen tarkoituksena oli kuvailla Kainuun ensihoidon laatua traumapotilaiden hoidossa. Opinnäytetyömme on tehty yhteistyössä Kainuun sosiaali- ja terveydenhuollon kuntayhtymän ensihoidon kanssa. Tutkimuksen tavoitteena oli hyödyntää tutkimusta Kainuun ensihoidossa traumapotilaiden hoidon kehittämisessä. Tutkimuksemme on toteutettu kvantitatiivisena ja retrospektiivisena tutkimuksena. Aineiston keräämiseen käytimme valmista tiedonkeruupohjaa, johon keräsimme 391 ensihoitotehtävän tiedot. Analysoimme tutkimuksen tulokset Excel- ja SPSS-ohjelmilla. Tutkimuksen perusteella 50 % (N= 196) traumapotilaista pääsi kultaisen tunnin aikana lopulliseen hoitopaikkaan. Keskimäärin ensihoitajilla kului kohteessa 21 minuuttia, joka on yli suositellun 10 minuutin. Tutkimuksen mukaan 15 %:lla (N= 58) ensihoitotehtävistä kuljetus päästiin aloittamaan 10 minuutin sisällä. Tutkimuksessa kävi ilmi, että mitä enemmän kohteessa tehtiin hoitotoimenpiteitä, sitä pidempi kohteessa oloaika oli. Tutkimuksessa kävi ilmi, että ensihoitotehtävien kokonaisajasta suurin osa kului matkalla potilaan luokse ja potilaan kuljettamiseen hoitolaitokseen. Tämä selittyy Kainuun alueen pitkillä välimatkoilla. Ensihoitotehtävien kokonaisaika kasvoi huomattavasti, mikäli potilas jatkokuljetettiin Kainuun keskussairaalasta yliopistolliseen sairaalaan Ouluun. Ensihoitotehtävillä, joissa potilas jatkokuljetettiin, aikaa kului merkittävästi keskussairaalassa potilaan tilan stabilointiin ennen jat-kokuljetuksen aloittamista. Tutkimme myös vaikuttaako ensihoitotehtävien kokonaisaikaan eri viranomaisjohtajuudet. Tutkimuksen perusteella voidaan todeta, että poliisijohtoisilla ensihoitotehtävillä kohteessa oloaika oli keskimäärin kaikista lyhyin. Opinnäytetyötämme voidaan hyödyntää ensihoidon laadun kehittämiseksi Kainuun ensihoidossa sekä henkilöstön ammattitaidon ylläpitämiseksi. Tutkimustuloksia voidaan käyttää simulaatiokoulutuksen suunnittelun tukena, jolloin tunnistetaan mahdolliset kehittämishaasteet ensihoitajien toiminnassa. Traumapotilaiden lopullinen hoito tapahtuu aina sairaalassa, jossa on mahdollista saada mm. leikkaushoitoa. Jotta traumapotilas saa parasta mahdollista hoitoa, tulee ensihoidossa pyrkiä mahdollisimman nopeaan kuljetukseen, jolla pyritään turvaamaan traumapotilaan nopea sairaalahoitoon pääsy.Purpose of this study was to describe the quality of emergency care in Kainuu in trauma patients care. Our thesis is made in co-operation with emergency care centre of Kainuu. Objective of the study was to exploit research in developing of care for trauma patients in emergency care of Kainuu. Our study is implemented as a quantitative and retrospective research. For collecting the material, we used ready data collection sheet which we gathered the information of 391 alarms. We analyzed the result of the research by using Excel- and SPSS-programs. Based on the study 50% (N= 196) of trauma patients were transported in the final sequel care facility during the golden hour. Paramedics spent approximately 21 minutes on scene which is over than the recommended 10 minutes. According to the study in 15% (N= 58) of the alarms transportation was achieved to start within 10 minutes. The study showed that the on-scene time was the longer the more procedures were accomplished in the destination. The study also showed that most of the time on the alarms were spent by travelling to the patient and transporting the patient to care facility. This is explained by the long distances of the area of Kainuu. The total time of alarms was highly increased if the patient was sequel transported from central Hospital of Kainuu to University Hospital in Oulu. In alarms which the patient was sequel transported, significant amount of time was spent in central Hospital stabilizing the patient before continuing the transport. We also investigated if authority leaderships affect to the total time spent on alarms. The study lightened out that in those alarms which was lead by police, the on-scene time was averagely shortest. Our thesis can be utilized in developing the quality of emergency care in Kainuu and maintaining the professionality of personnel. Results of the study can be used as a support of simulation education which allows to identify the possible developing challenges in the action of paramedics. The final care of trauma patients always occurs at hospital where multiple procedures are availa-ble. To guarantee that the patient receives best care, must emergency care always strive to quick transportation which secures that patients gets quickly the care they need

DALI:Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial - study protocol

BACKGROUND: Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women. METHODS/DESIGN: Pregnant women at risk of GDM (BMI 65 29 (kg/m(2))) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucose<5.1 mmol; 1 hour glucose <10.0 mmol; 2 hour glucose <8.5 mmol) and randomized to one of the 8 intervention arms using a 2 7 (2 7 2) factorial design: (1) healthy eating (HE), 2) physical activity (PA), 3) HE+PA, 4) control, 5) HE+PA+vitamin D, 6) HE+PA+placebo, 7) vitamin D alone, 8) placebo alone), pre-stratified for each site. In total, 880 women will be included with 110 women allocated to each arm. Between entry and 35 weeks of gestation, women allocated to a lifestyle intervention will receive 5 face-to-face, and 4 telephone coaching sessions, based on the principles of motivational interviewing. The lifestyle intervention includes a discussion about the risks of GDM, a weight gain target <5 kg and either 7 healthy eating 'messages' and/or 5 physical activity 'messages' depending on randomization. Fidelity is monitored by the use of a personal digital assistance (PDA) system. Participants randomized to the vitamin D intervention receive either 1600 IU vitamin D or placebo for daily intake until delivery. Data is collected at baseline measurement, at 24-28 weeks, 35-37 weeks of gestation and after delivery. Primary outcome measures are gestational weight gain, fasting glucose and insulin sensitivity, with a range of obstetric secondary outcome measures including birth weight. DISCUSSION: DALI is a unique Europe-wide randomised controlled trial, which will gain insight into preventive measures against the development of GDM in overweight and obese women

Mediators of lifestyle behaviour changes in obese pregnant women. Secondary analyses from the DALI lifestyle randomised controlled trial

A better understanding of what drives behaviour change in obese pregnant overweight women is needed to improve the effectiveness of lifestyle interventions in this group at risk for gestational diabetes (GDM). Therefore, we assessed which factors mediated behaviour change in the Vitamin D and Lifestyle Intervention for GDM Prevention (DALI) Lifestyle Study. A total of 436 women, with pre-pregnancy body mass index ≥29 kg/m 2 , ≤19 + 6 weeks of gestation and without GDM, were randomised for counselling based on motivational interviewing (MI) on healthy eating and physical activity, healthy eating alone, physical activity alone, or to a usual care group. Lifestyle was measured at baseline, and at 24–28 and 35–37 weeks of gestation. Outcome expectancy, risk perception, task self-efficacy and social support were measured at those same time points and considered as possible mediators of intervention effects on lifestyle. All three interventions resulted in increased positive outcome expectancy for GDM reduction, perceived risk to the baby and increased task self-efficacy. The latter mediated intervention effects on physical activity and reduced sugared drink consumption. In conclusion, our MI intervention was successful in increasing task self-efficacy, which was related to improved health behaviours

Cost-effectiveness of healthy eating and/or physical activity promotion in pregnant women at increased risk of gestational diabetes mellitus

__Background:__ Gestational diabetes mellitus (GDM) is associated with perinatal health risks to both mother and offspring, and represents a large economic burden. The DALI study is a multicenter randomized controlled trial, undertaken to add to the knowledge base on the effectiveness of interventions for pregnant women at increased risk for GDM. The purpose of this study was to evaluate the cost-effectiveness of the healthy eating and/or physical activity promotion intervention compared to usual care among pregnant women at increased risk of GDM from a societal perspective. __Methods:__ An economic evaluation was performed alongside a European multicenter-randomized controlled trial. A total of 435 pregnant women at increased risk of GDM in primary and secondary care settings in nine European countries, were recruited and randomly allocated to a healthy eating and physical activity promotion intervention (HE + PA intervention), a healthy eating promotion intervention (HE intervention), or a physical activity promotion intervention (PA intervention). Main outcome measures were gestational weight gain, fasting glucose, insulin resistance (HOMA-IR), quality adjusted life years (QALYs), and societal costs. __Results:__ Between-group total cost and effect differences were not significant, besides significantly less gestational weight gain in the HE + PA group compared with the usual care group at 35-37 weeks ( 2.3;95%CI:-3.7;-0.9). Cost-effectiveness acceptability curves indicated that the HE + PA intervention was the preferred intervention strategy. At 35-37 weeks, it depends on the decision-makers' willingness to pay per kilogram reduction in gestational weight gain whether the HE + PA intervention is cost-effective for gestational weight gain, whereas it was not cost-effective for fasting glucose and HOMA-IR. After delivery, the HE + PA intervention was cost-effective for QALYs, which was predominantly caused by