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Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomized controlled trial.

ABSTRACT: BACKGROUND: The global obesity epidemic has led to increased attention on pregnancy, a period when women are at risk of gaining excessive weight. Excessive gestational weight gain is associated with numerous complications, for both mother and child. Though the problem is widespread, few studies have examined the effect of a lifestyle intervention in pregnancy designed to limit maternal weight gain. The Fit for Delivery study will explore the effectiveness of nutritional counseling coupled with exercise classes compared with standard prenatal care. The aims of the study are to examine the effect of the intervention on maternal weight gain, newborn birth weight, glucose regulation, complications of pregnancy and delivery, and maternal weight retention up to 12 months postpartum. METHODS/DESIGN: Fit for Delivery is a randomized controlled trial that will include 600 women expecting their first child. To be eligible, women must be 18 years of age or older, of less than 20 weeks gestational age, with a singleton pregnancy, and have a Body Mass Index (BMI) ? 19 kg/m2. The women will be randomly allocated to either an intervention group or a control group. The control group will receive standard prenatal care. The intervention group will, in addition, receive nutritional counseling by phone, access to twice-weekly exercise sessions, and information on healthy eating and physical activity provided in pamphlets, evening meetings and an interactive website. Both groups will be monitored by weighing (including bioimpedance measurements of percent body fat), blood tests, self-report questionnaires and hospital record review. DISCUSSION: Weight gained in pregnancy affects the health of both the mother and her unborn child, and simple models for efficient intervention are in high demand. The Fit for Delivery intervention provides concrete advice on limiting energy intake and practical training in increasing physical activity. This lifestyle intervention is simple, reproducible, and inexpensive. The design of the study reflects the realities of clinical practice, where patients are free to choose whether or not they respond to health initiatives. If we find measurable health benefits associated with the intervention, it may be an easily adopted supplement to routine prenatal care, in the prevention of obesity. TRIAL REGISTRATION: ClinicalTrial.gov, NCT01001689.

SUBMITTER: Sagedal LR

PROVIDER: S-EPMC3577450 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomized controlled trial.

Sagedal Linda Reme LR Øverby Nina C NC Lohne-Seiler Hilde H Bere Elling E Torstveit Monica K MK Henriksen Tore T Vistad Ingvild I

BMC public health 20130213

<h4>Background</h4>The global obesity epidemic has led to increased attention on pregnancy, a period when women are at risk of gaining excessive weight. Excessive gestational weight gain is associated with numerous complications, for both mother and child. Though the problem is widespread, few studies have examined the effect of a lifestyle intervention in pregnancy designed to limit maternal weight gain. The Fit for Delivery study will explore the effectiveness of nutritional counseling coupled ...[more]

PMID: 23406306

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Project description:BACKGROUND:To develop effective health promotional and preventive prenatal programs, it is important to understand perceived barriers to leisure-time physical activity during pregnancy, including exercise and sport participation. The aims of the present study was 1) to assess the effect of prenatal lifestyle intervention on the perceived barrier to leisure-time physical activity during pregnancy and the first year after delivery and 2) identify the most important perceived barriers to leisure-time physical activity at multiple time points during and after pregnancy. METHODS:This secondary analysis was part of the Norwegian Fit for Delivery study, a combined lifestyle intervention evaluated in a blinded, randomized controlled trial. Healthy, nulliparous women with singleton pregnancy of ?20 gestational weeks, age???18 years and body mass index ?19 kg/m2 were recruited via healthcare clinics in southern Norway, including urban and rural settings. Participants were randomized to either twice-weekly supervised exercise sessions and nutritional counselling (n?=?303) or standard prenatal care (n?=?303). The principal analysis was based on the participants who completed the standardized questionnaire assessing their perceived barriers to leisure-time physical activity at inclusion (gestational week 16, n?=?589) and following intervention (gestational week 36, n?=?509), as well as six months (n?=?470) and 12 months (n?=?424) postpartum. RESULTS:Following intervention (gestation week 35.4?±?1.0), a significant between-group difference in perceived barriers to leisure-time physical activity was found with respect to time constraints: "... I do not have the time" (intervention: 22 vs. control: 38, p?=?0.030), mother-child safety concerns: "... afraid to harm the baby" (intervention: 8 vs. control: 25, p?=?0.002) and self-efficacy: "... I do not believe/think that I can do it" (intervention: 3 vs. control: 10, p?=?0.050). No positive effect was seen at postpartum follow-up. Intrapersonal factors (lack of time, energy and interest) were the most frequently perceived barriers, and consistent over time among all participants. CONCLUSION:The intervention had effect on intrapersonal perceived barriers in pregnancy, but not in the postpartum period. Perceived barriers to leisure-time physical activity were similar from early pregnancy to 12 months postpartum. TRIAL REGISTRATION:ClinicalTrials.gov: NCT01001689 , registered July 2, 2009.

Project description:The effectiveness of prenatal lifestyle intervention to prevent gestational diabetes and improve maternal glucose metabolism remains to be established. The Norwegian Fit for Delivery (NFFD) randomized, controlled trial studied the effect of a combined lifestyle intervention provided to a general population, and found significantly lower gestational weight gain among intervention participants but no improvement in obstetrical outcomes or the proportion of large infants. The aim of the present study is to examine the effect of the NFFD intervention on glucose metabolism, including an assessment of the subgroups of normal-weight and overweight/obese participants.Healthy, non-diabetic women expecting their first child, with pre-pregnancy body mass index (BMI) ?19 kg/m2, age ? 18 years and a singleton pregnancy of ?20 gestational-weeks were enrolled from healthcare clinics in southern Norway. Gestational weight gain was the primary endpoint. Participants (n = 606) were individually randomized to intervention (two dietary consultations and access to twice-weekly exercise groups) or control group (routine prenatal care). The effect of intervention on glucose metabolism was a secondary endpoint, measuring glucose (fasting and 2-h following 75-g glucose load), insulin, homeostatic assessment of insulin resistance (HOMA-IR) and leptin levels at gestational-week 30.Blood samples from 557 (91.9%) women were analyzed. For the total group, intervention resulted in reduced insulin (adj. Mean diff -0.91 mU/l, p = 0.045) and leptin levels (adj. Mean diff -207 pmol/l, p = 0.021) compared to routine care, while glucose levels were unchanged. However, the effect of intervention on both fasting and 2-h glucose was modified by pre-pregnancy BMI (interaction p = 0.030 and p = 0.039, respectively). For overweight/obese women (n = 158), intervention was associated with increased risk of at least one glucose measurement exceeding International Association of Pregnancy and Diabetes Study Group thresholds (33.7% vs. 13.9%, adj. OR 3.89, p = 0.004).The Norwegian Fit for Delivery intervention lowered neither glucose levels nor GDM incidence, despite reductions in insulin and leptin. Prenatal combined lifestyle interventions designed for a general population may be unsuited to reduce GDM risk, particularly among overweight/obese women, who may require earlier and more targeted interventions.ClinicalTrials.gov ID NCT01001689 , registered July 2, 2009, confirmed completed October 26, 2009 (retrospectively registered).

Project description:Abstract Background Interactions between polymorphisms of the melatonin receptor 1B gene (MTNR1B) and lifestyle intervention for gestational diabetes have been described. Whether these are specific for physical activity or healthy eating intervention is unknown. Objectives To assess the interaction between MTNR1B rs10830962 and rs10830963 polymorphisms and lifestyle interventions during pregnancy. Methods Women with a BMI of ≥ 29 kg/m2 (n = 436) received counseling on healthy eating (HE), physical activity (PA) or both. The control group received usual care. The analysis had a factorial design with comparison of HE versus no HE and PA versus no PA. Maternal outcomes at 24-28 weeks were gestational weight gain (GWG), maternal fasting glucose, insulin, insulin resistance (HOMA-IR), and development of GDM. Interaction between receiving either HE or PA intervention and genotypes of both rs10830962 and rs10830963 was assessed using multilevel regression analysis. Results GDM risk was increased in women homozygous for the G allele of rs10830962 or rs10830963 (OR 2.60 [95% CI 1.34, 5.06] and 2.83 [1.24, 6.47], respectively). Significant interactions between rs10830962 and interventions were found: In women homozygous for the G allele, but not in the other genotypes, the PA intervention reduced maternal fasting insulin (beta -0.16 [95%CI -0.33, 0.02], p = 0.08) and HOMA-IR (-0.17 [-0.35, 0.01], p = 0.06). In heterozygous women, HE intervention had no effect, whereas in women homozygous for the C allele, HE intervention reduced GWG (-1.6 kg [-2.4, -0.8]). Discussion In women homozygous for the risk allele of MTNR1B rs10830962, GDM risk was increased and PA intervention might be more beneficial than HE intervention for reducing maternal insulin resistance. Key messages In women homozygous for the risk allele of MTNR1B rs10830962, risk of gestational diabetes was increased. For these women, PA intervention might be more beneficial than HE intervention for reducing maternal insulin resistance.

Project description:BackgroundWomen with obesity and infertility are counseled to lose weight prior to conception and infertility treatment to improve pregnancy rates and birth outcomes, although confirmatory evidence from randomized trials is lacking. We assessed whether a preconception intensive lifestyle intervention with acute weight loss is superior to a weight neutral intervention at achieving a healthy live birth.Methods and findingsIn this open-label, randomized controlled study (FIT-PLESE), 379 women with obesity (BMI ≥ 30 kg/m2) and unexplained infertility were randomly assigned in a 1:1 ratio to 2 preconception lifestyle modification groups lasting 16 weeks, between July 2015 and July 2018 (final follow-up September 2019) followed by infertility therapy. The primary outcome was the healthy live birth (term infant of normal weight without major anomalies) incidence. This was conducted at 9 academic health centers across the United States. The intensive group underwent increased physical activity and weight loss (target 7%) through meal replacements and medication (Orlistat) compared to a standard group with increased physical activity alone without weight loss. This was followed by standardized empiric infertility treatment consisting of 3 cycles of ovarian stimulation/intrauterine insemination. Outcomes of any resulting pregnancy were tracked. Among 191 women randomized to standard lifestyle group, 40 dropped out of the study before conception; among 188 women randomized to intensive lifestyle group, 31 dropped out of the study before conception. All the randomized women were included in the intent-to-treat analysis for primary outcome of a healthy live birth. There were no significant differences in the incidence of healthy live births [standard 29/191(15.2%), intensive 23/188(12.2%), rate ratio 0.81 (0.48 to 1.34), P = 0.40]. Intensive had significant weight loss compared to standard (-6.6 ± 5.4% versus -0.3 ± 3.2%, P < 0.001). There were improvements in metabolic health, including a marked decrease in incidence of the metabolic syndrome (baseline to 16 weeks: standard: 53.6% to 49.4%, intensive 52.8% to 32.2%, P = 0.003). Gastrointestinal side effects were significantly more common in intensive. There was a higher, but nonsignificant, first trimester pregnancy loss in the intensive group (33.3% versus 23.7% in standard, 95% rate ratio 1.40, 95% confidence interval [CI]: 0.79 to 2.50). The main limitations of the study are the limited power of the study to detect rare complications and the design difficulty in finding an adequate time matched control intervention, as the standard exercise intervention may have potentially been helpful or harmful.ConclusionsA preconception intensive lifestyle intervention for weight loss did not improve fertility or birth outcomes compared to an exercise intervention without targeted weight loss. Improvement in metabolic health may not translate into improved female fecundity.Trial registrationClinicalTrials.gov NCT02432209.

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Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomized controlled trial.

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Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomized controlled trial.

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