Identifying Personality Characteristics and Indicators of Psychological Well-Being Associated With Attrition in the Motivation Makes the Move! Physical Activity Intervention: Randomized Technology-Supported Trial.

BACKGROUND: Data attrition has been a common problem in longitudinal lifestyle interventions. The contributors to attrition in technology-supported physical activity interventions have not been thoroughly studied. OBJECTIVE: The present study examined the roles of personality characteristics and indicators of psychological well-being in data attrition within a technology-supported, longitudinal intervention study with overweight adults. METHODS: Participants (N=89) were adults from the Motivation Makes the Move! intervention study. Data attrition was studied after a 3-month follow-up. Participants' personality characteristics were studied using the Short Five self-report questionnaire. Psychological well-being indicators were assessed with the RAND 36-item health survey, Positive and Negative Affect Schedule, and Beck Depression Inventory. Logistic regression analyses were conducted to assess the risk of discontinuing the study. The analyses were adjusted for sex, age, study group, and educational status. RESULTS: At the 3-month follow-up, 65 of 89 participants (73% of the initial sample) had continued in the study. Participants' personality characteristics and indicators of psychological well-being were not associated with the risk of dropping out of the study (all P values >.05). The results remained the same after covariate controls. CONCLUSIONS: Participant attrition was not attributable to personality characteristics or psychological well-being in the Motivation Makes the Move! study conducted with overweight adults. As attrition remains a challenge within longitudinal, technology-supported lifestyle interventions, attention should be paid to the potentially dynamic natures of personality and psychological well-being, as well as other elements beyond these. TRIAL REGISTRATION: ClinicalTrials.gov NCT02686502; https://clinicaltrials.gov/ct2/show/NCT02686502.

Prevention of gestational diabetes with a prepregnancy lifestyle intervention - findings from a randomized controlled trial.

PURPOSE: Lifestyle intervention studies performed during pregnancy have shown inconsistent results in relation to prevention of gestational diabetes mellitus (GDM). Therefore, the aim of this study was to assess the effect of an intervention initiated already before pregnancy in prevention of GDM in high-risk women. PATIENTS AND METHODS: A randomized controlled trial was conducted in four Finnish maternity hospitals between the years 2008 and 2014. Altogether 228 high-risk women planning pregnancy were randomized to an intervention (n=116) or a control group (n=112). The risk factors were body mass index ≥30 kg/m2 (n=46), prior GDM (n=120), or both (n=62), without manifest diabetes at study inclusion. Trained study nurses provided individualized lifestyle counseling every 3 months in addition to a group session with a dietician. The control group received standard antenatal care. GDM was defined as one or more pathological glucose values in a 75 g 2-hour oral glucose tolerance test, performed between 12 and 16 weeks of gestation and if normal repeated between 24 and 28 weeks of gestation. RESULTS: Within 12 months, 67% of the women (n=72) in the intervention group and 63% of the women (n=71) in the control group (p=0.84) became pregnant. The cumulative incidence of GDM among the women available for the final analyses was 60% (n=39/65) in the intervention group and 54% (n=34/63) in the control group (p=0.49). GDM was diagnosed already before 20 weeks of gestation in 60% (n=44/73) of the cases. CONCLUSION: The preconceptional lifestyle intervention applied in the present study did not reduce the incidence of GDM.

Effect of a lifestyle intervention during pregnancy-findings from the Finnish gestational diabetes prevention trial (RADIEL).

OBJECTIVE: To assess the effect of lifestyle counseling on perinatal outcomes among women at high risk for gestational diabetes. STUDY DESIGN: A total of 492 women with obesity and/or prior gestational diabetes were allocated to intervention (four sessions of lifestyle counseling, n = 249) or usual care (n = 243) before 20 weeks' gestation. RESULT: Lifestyle indicators, gestational weight gain, or obstetric and perinatal outcomes did not differ between the two groups. An oral glucose tolerance test in the first half of pregnancy was pathological in 37.7% (n = 87/144) of intervention and 36.5% (n = 72/197) of control group women (p = 0.81). The total incidence of gestational diabetes diagnosed in the first or second half of pregnancy was 44.8% (107/239) in the intervention and 48.1% (111/231) in the control group (p = 0.48). CONCLUSIONS: The high prevalence of impaired glucose metabolism was observed already in early pregnancy, which may have contributed to the lack of effect of the intervention.

Altered cardiorespiratory response to exercise in overweight and obese women with polycystic ovary syndrome.

In polycystic ovary syndrome (PCOS), cardiovascular risk is increased. Peak O2 uptake (V˙O2peak) predicts the cardiovascular risk. We were the first to examine the contribution of systemic O2 delivery and arteriovenous O2 difference to V˙O2peak in overweight and obese women with PCOS. Fifteen overweight or obese PCOS women and 15 age-, anthropometry-, and physical activity-matched control women performed a maximal incremental cycling exercise test. Alveolar gas exchange (volume turbine and mass spectrometry), arterial O2 saturation (pulse oximetry), and cardiac output (CO) (impedance cardiography) were monitored. Hb concentration was determined. Arterial O2 content and arteriovenous O2 difference (C(a-v)O2) (Fick equation) were calculated. Insulin resistance was evaluated by homeostasis model assessment (HOMA-IR). PCOS women had lower V˙O2peak than controls (40 ± 6 vs. 46 ± 5 mL/min/kg fat-free mass [FFM], P = 0.011). Arterial O2 content was similarly maintained in the groups throughout the exercise test (P > 0.05). Linear regression analysis revealed a pronounced response of CO to increasing V˙O2 in PCOS women during the exercise test: A ∆CO/∆V˙O2 slope was steeper in PCOS women than in controls (ß = 5.84 vs. ß = 5.21, P = 0.004). Eventually, the groups attained similar peak CO and peak CO scaled to FFM (P > 0.05). Instead, C(a-v)O2 at peak exercise was lower in PCOS women than in controls (13.2 ± 1.6 vs. 14.8 ± 2.4 mL O2/100 mL blood, P = 0.044). HOMA-IR was similar in the groups (P > 0.05). The altered cardiorespiratory responses to exercise in overweight and obese PCOS women indicate that PCOS per se is associated with alterations in peripheral adjustments to exercise rather than with limitations of systemic O2 delivery.

Heterogeneity of maternal characteristics and impact on gestational diabetes (GDM) risk-Implications for universal GDM screening?

OBJECTIVE: To study the incidence of gestational diabetes mellitus (GDM) in relation to phenotypic characteristics and gestational weight gain (GWG) among women at high risk for GDM. MATERIALS AND METHODS: This is a secondary analysis of a GDM prevention study (RADIEL), a randomized controlled trial conducted in Finland. 269 women with a history of GDM and/or a pre-pregnancy body mass index (BMI) ≥ 30 kg/m(2) were enrolled before 20 weeks of gestation and divided into four groups according to parity, BMI and previous history of GDM. The main outcome was incidence of GDM. RESULTS: There was a significant difference in incidence of GDM between the groups (p < 0.001). Women with a history of GDM and BMI <30 kg/m(2) showed the highest incidence (35.9%). At baseline they had fewer metabolic risk factors and by the second trimester they gained more weight. There was no interaction between GWG and GDM outcome and no significant difference in the prevalence of diabetes-associated antibodies. CONCLUSION: Despite a healthier metabolic profile at baseline the non-obese women with a history of GDM displayed a markedly higher cumulative incidence of GDM. GWG and the presence of diabetes-associated antibodies were not associated with GDM occurrence among these high-risk women. Key message Despite a healthier metabolic profile at baseline the non-obese women with previous gestational diabetes mellitus display a markedly higher cumulative incidence of gestational diabetes mellitus.

Gestational Diabetes Mellitus Can Be Prevented by Lifestyle Intervention: The Finnish Gestational Diabetes Prevention Study (RADIEL): A Randomized Controlled Trial.

OBJECTIVE: To assess whether gestational diabetes mellitus (GDM) can be prevented by a moderate lifestyle intervention in pregnant women who are at high risk for the disease. RESEARCH DESIGN AND METHODS: Two hundred ninety-three women with a history of GDM and/or a prepregnancy BMI of ≥30 kg/m(2) were enrolled in the study at <20 weeks of gestation and were randomly allocated to the intervention group (n = 155) or the control group (n = 138). Each subject in the intervention group received individualized counseling on diet, physical activity, and weight control from trained study nurses, and had one group meeting with a dietitian. The control group received standard antenatal care. The diagnosis of GDM was based on a 75-g, 2-h oral glucose tolerance test at 24-28 weeks of gestation. RESULTS: A total of 269 women were included in the analyses. The incidence of GDM was 13.9% in the intervention group and 21.6% in the control group ([95% CI 0.40-0.98%]; P = 0.044, after adjustment for age, prepregnancy BMI, previous GDM status, and the number of weeks of gestation). Gestational weight gain was lower in the intervention group (-0.58 kg [95% CI -1.12 to -0.04 kg]; adjusted P = 0.037). Women in the intervention group increased their leisure time physical activity more and improved their dietary quality compared with women in the control group. CONCLUSIONS: A moderate individualized lifestyle intervention reduced the incidence of GDM by 39% in high-risk pregnant women. These findings may have major health consequences for both the mother and the child.

Elevated serum squalene and cholesterol synthesis markers in pregnant obese women with gestational diabetes mellitus.

We examined serum cholesterol synthesis and absorption markers and their association with neonatal birth weight in obese pregnancies affected by gestational diabetes mellitus (GDM). Pregnant women at risk for GDM (BMI >30 kg/m²) were enrolled from maternity clinics in Finland. GDM was determined from the results of an oral glucose tolerance test. Serum samples were collected at six time-points, one in each trimester of pregnancy, and at 6 weeks, 6 months, and 12 months postpartum. Analysis of serum squalene and noncholesterol sterols by gas-liquid chromatography revealed that in subjects with GDM (n = 22), the serum Δ8-cholestenol concentration and lathosterol/sitosterol ratio were higher (P < 0.05) than in the controls (n = 30) in the first trimester, reflecting increased cholesterol synthesis. Also, subjects with GDM had an increased ratio of squalene to cholesterol (100 × µmol/mmol of cholesterol) in the second (11.5 ± 0.5 vs. 9.1 ± 0.5, P < 0.01) and third (12.1 ± 0.8 vs. 10.0 ± 0.7, P < 0.05) trimester. In GDM, the second trimester maternal serum squalene concentration correlated with neonatal birth weight (r = 0.70, P < 0.001). In conclusion, in obesity, GDM associated with elevated serum markers of cholesterol synthesis. Correlation of maternal serum squalene with neonatal birth weight suggests a potential contribution of maternal cholesterol synthesis to newborn weight in GDM.

Prevention of gestational diabetes through lifestyle intervention: study design and methods of a Finnish randomized controlled multicenter trial (RADIEL).

BACKGROUND: Maternal overweight, obesity and consequently the incidence of gestational diabetes are increasing rapidly worldwide. The objective of the study was to assess the efficacy and cost-effectiveness of a combined diet and physical activity intervention implemented before, during and after pregnancy in a primary health care setting for preventing gestational diabetes, later type 2 diabetes and other metabolic consequences. METHODS: RADIEL is a randomized controlled multi-center intervention trial in women at high risk for diabetes (a previous history of gestational diabetes or prepregnancy BMI ≥30 kg/m2). Participants planning pregnancy or in the first half of pregnancy were parallel-group randomized into an intervention arm which received lifestyle counseling and a control arm which received usual care given at their local antenatal clinics. All participants visited a study nurse every three months before and during pregnancy, and at 6 weeks, 6 and 12 months postpartum. Measurements and laboratory tests were performed on all participants with special focus on dietary and exercise habits and metabolic markers.Of the 728 women [mean age 32.5 years (SD 4.7); median parity 1 (range 0-9)] considered to be eligible for the study 235 were non-pregnant and 493 pregnant [mean gestational age 13 (range 6 to 18) weeks] at the time of enrollment. The proportion of nulliparous women was 29.8% (n = 217). Out of all participants, 79.6% of the non-pregnant and 40.4% of the pregnant women had previous gestational diabetes and 20.4% of the non-pregnant and 59.6% of the pregnant women were recruited because of a prepregnancy BMI ≥30 kg/m2. Mean BMI at first visit was 30.1 kg/m2 (SD 6.2) in the non-pregnant and 32.7 kg/m2 (SD 5.6) in the pregnant group. DISCUSSION: To our knowledge, this is the first randomized lifestyle intervention trial, which includes, besides the pregnancy period, both the prepregnancy and the postpartum period. This study design also provides an opportunity to focus upon the health of the next generation. The study is expected to produce novel information on the optimal timing and setting of interventions and for allocating resources to prevent obesity and diabetes in women of reproductive age.

Alterations of sympathetic nervous system, coagulation and platelet function in gestational diabetes.

Gestational diabetes is associated with increased risk for venous thromboembolism. Activation of sympathetic nervous system affects blood coagulation, fibrinolysis and platelet activation by several mechanisms. We aimed to study the relationship of sympathetic nervous system, coagulation and platelet function in gestational diabetes. Forty-one white women with gestational diabetes, 22 healthy pregnant and 14 nonpregnant controls were studied. We assayed serial nocturnal (at 12 p.m., 4 a.m. and 7 a.m.) changes of the adrenergic transmitter noradrenaline, coagulation variables and platelet activation with PFA-100. Plasma noradrenaline increased from 4 to 7 a.m. in both pregnant groups. During the same time period, prothrombin time (PT) shortened in gestational diabetes compared with healthy pregnant and nonpregnant controls. In gestational diabetes, nocturnal FVIII:C levels were lower compared with normal pregnancy and also variables associated with von Willebrand factor tended to be lower. Platelet activity increased at midnight in pregnant women compared with nonpregnant women without differences between gestational diabetes and normal pregnancy. Gestational diabetes is associated with concomitant early morning sympathetic stimulation and activation of extrinsic coagulation pathway (shortened PT). Decreased FVIII:C may refer to compensatory anticoagulatory mechanism. These alterations could reflect increased risk of pregnancy-related thromboembolism in gestational diabetes.

Decreased variation of inflammatory markers in gestational diabetes.

BACKGROUND: Gestational diabetes is a prediabetic state. Sub-clinical inflammation may play a role in the transition from gestational diabetes to type 2 diabetes; the role of the autonomic nervous system as a mediating system has been raised. We aimed to study the association of the sympathetic nervous system and sub-clinical inflammation in women with gestational diabetes. METHODS: We studied 41 Caucasian women with gestational diabetes and 22 healthy pregnant and 14 non-pregnant controls. We assayed plasma noradrenaline, insulin, C-reactive protein, interleukin-6, insulin growth factor-1, serum amyloid A, steroid hormone-binding globulin, α-1 acid glycoprotein and cortisol at 2400, 0400 and 0700 h. RESULTS: No differences existed in the concentrations of inflammatory markers between gestational diabetes and normal pregnancy but women with gestational diabetes showed loss of variation in C-reactive protein and serum amyloid A. Levels of hormone-binding globulin were lower in hypertensive compared with normotensive women with gestational diabetes at all time points and lowest at midnight when α-1 acid glycoprotein levels were higher in hypertensive women. CONCLUSIONS: Gestational diabetes is associated with loss of natural variation of C-reactive protein and serum amyloid A, suggesting altered modulation of inflammation. Hypertension in gestational diabetes seems not to be associated with higher levels of inflammatory markers other than α-1 acid glycoprotein.

Central sympatholytic therapy has anti-inflammatory properties in hypertensive postmenopausal women.

OBJECTIVE: Postmenopausal phase expresses many unfavourable physiological changes that lead to increased risk for cardiovascular disease. We compared the effect of two sympatholytic antihypertensive drug treatments, the centrally acting imidazoline receptor-1 agonist moxonidine and peripherally acting beta-blocking agent atenolol on sensitive inflammatory markers in overweight postmenopausal women with diastolic hypertension. METHODS: This was a multicentre, multinational double-blinded, prospective study comparing moxonidine (0.3 mg twice daily) with atenolol (50 mg once daily) in 87 hypertensive postmenopausal overweight women who were not taking hormone therapy. Sensitive C-reactive protein, IL-6, TNFalpha, TNFalpha-RII and adiponectin were determined in the beginning of the study and after 8 weeks of medical treatment. RESULTS: TNFalpha increased in atenolol and decreased in moxonidine group (P = 0.0004 between the groups). Adiponectin concentration decreased dramatically in atenonol but did not change in moxonidine treatment group (P < 0.0001 between the groups). In logistic regression analysis only treatment group showed an independent effect on changes in adiponectin and TNFalpha concentrations. CONCLUSION: We believe that centrally acting sympatholytic agent moxonidine is beneficial in the treatment of postmenopausal women with hypertension by reducing inflammatory cytokine TNFalpha without changing protective adiponectin level.

Use of insulin glargine during pregnancy.

BACKGROUND: Good metabolic control maintained throughout pregnancy reduces maternal and fetal complications in diabetic women. The long-acting insulin analogue glargine has 24-h persistence and a peakless action profile, and could contribute to more stable daily plasma glucose levels and improved glycemic control. We evaluated the metabolic control associated with insulin glargine during pregnancy in comparison with conventional basal insulin therapy. METHODS: Retrospective case-control analysis of glycemic control and pregnancy complications in 100 type 1 diabetic pregnancies with intermediate-acting NPH insulin or insulin glargine prior to conception and throughout pregnancy. RESULTS: Overall,glycemic control was not different between the groups, though the decrease in HbA1c from the first to the third trimester was greater with insulin glargine (0.8 versus 0.3%, p=0.04). The rate of hypoglycemia was comparable. CONCLUSIONS: Our findings suggest that, as regards metabolic control, insulin glargine in women with type 1 diabetes is comparable with NPH insulin as basal insulin therapy. No adverse effects were associated with glargine use at the time of conception and during pregnancy.

Insulin resistance and sympathetic overactivity in women.

Insulin sensitivity decreases for the first time in females at the time of menarche. A much more profound decrease in insulin sensitivity is observed at the end of pregnancy. This physiological insulin resistance is not accompanied by a rise in overall sympathetic activity as reflected in plasma noradrenaline levels, but there is evidence of moderate sympathetic overactivity in muscle and the heart. Pre-eclampsia is characterized by increased insulin resistance, sympathetic overactivity and a particular lipid profile. Thus it is the first manifestation of metabolic syndrome. Women with a history of pre-eclampsia have persistent insulin resistance after pregnancy associated with increased sympathetic activity of the cardiovascular system, and coronary artery disease later in life. Aging is accompanied by a greater increase in sympathetic traffic in women than in men, and inflammation (measured via C-reactive protein) seems to be more strongly related to metabolic syndrome in women than in men. The clinical relevance of these observations remains to be shown. As the key factors of metabolic syndrome, such as insulin resistance and sympathetic overactivity, are closely inter-related, treatment should be aimed at cutting the vicious circle at many points: lifestyle modification (diet, increasing exercise) as a basis of therapy, use of insulin sensitizers (e.g. metformin) to decrease insulin resistance, central sympatholytics (e.g. moxonidine), and AT-receptor blockers or angiotensin-converting enzyme (ACE) inhibitors to overcome sympathetic overactivity, hypertension and inflammation.

50gram oral glucose challenge test combined with risk factor-based screening for gestational diabetes.

OBJECTIVE: Our aim was to study whether universal screening of all pregnant women by Oral Glucose Challenge Test (OGCT) would identify a higher number of women with Gestational Diabetes (GDM) than risk factor based screening. STUDY DESIGN: A 50 g OGCT test was performed prospectively in 532 unselected women at 26-28 weeks of gestation. The 1-h venous plasma glucose concentration of >7.3 mmol/l was considered as a positive screening result. Patients with a positive OGCT underwent a 75 g 2-h OGTT, which was used as the actual diagnostic test for GDM. When two or all three of the glucose concentrations in OGTT (measured at fasting state and 1 and 2 h after the 75 g glucose load) were above the 97.5th percentile the patient was considered as having GDM. In addition, women with risk factors for GDM also underwent a 75 g OGTT regardless of the result of the OGCT. RESULTS: A positive 50 g OGCT was obtained in 123 (23%) of the women. In 15 (12%) of these, a diagnosis of GDM was established by the subsequent OGTT. Out of the 409 remaining women with a normal OGCT, 148 (36%) had risk factors for GDM. An OGTT performed in these patients identified 4 additional women with a GDM. Seventy-nine percent of GDM was thus found with 50g OGCT without regarding risk factors. Forty-seven percent of the women with GDM would have been missed in screening by risk factors only. CONCLUSIONS: In our population 50 g OGCT appears to identify a higher number of GDM than risk factor based screening. Combined with risk factor screening a few more cases of GDM would be found.