Dataset Information

Effects of a preconception lifestyle intervention in obese infertile women on diet and physical activity; A secondary analysis of a randomized controlled trial.

ABSTRACT:

Background

Lifestyle changes are notoriously difficult. Since women who intend to become pregnant are more susceptible to lifestyle advice, interventions during this time window might be more effective than interventions during any other period in life. We here report the effects of the first large preconception lifestyle intervention RCT on diet and physical activity in obese infertile women.

Methods

In total, 577 women were randomized between a six-month lifestyle intervention program (intervention group; N = 290) or prompt infertility treatment (control group; N = 287). Self-reported dietary behaviors and physical activity were assessed at baseline, three, six and twelve months after randomization. Mixed models were used to analyze differences between groups.

Results

Compared to the control group, the intervention group reduced their intake of sugary drinks at three months (-0.5 glasses/day [95% C.I. = -0.9;-0.2]), of savory snacks at three (-2.4 handful/week [-3.4;-1.4]) and at six months (-1.4 handful/week [-2.6;-0.2]), and of sweet snacks at three (-2.2 portion/week [-3.3;-1.0]) and twelve months after randomization (-1.9 portion/week [-3.5;-0.4]). Also, the intervention group was more moderate to vigorous physically active at three months after randomization compared to the control group (169.0 minutes/week [6.0; 332.1]).

Conclusion

Our study showed that obese infertile women who followed a six-month preconception lifestyle intervention program decreased their intake of high caloric snacks and beverages, and increased their physical activity. These changes in lifestyle may not only improve women's health but their offspring's health too.

SUBMITTER: van Elten TM

PROVIDER: S-EPMC6221548 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

Effects of a preconception lifestyle intervention in obese infertile women on diet and physical activity; A secondary analysis of a randomized controlled trial.

van Elten Tessa M TM Karsten Matty D A MDA Geelen Anouk A van Oers Anne M AM van Poppel Mireille N M MNM Groen Henk H Gemke Reinoud J B J RJBJ Mol Ben Willem BW Mutsaerts Meike A Q MAQ Roseboom Tessa J TJ Hoek Annemieke A

PloS one 20181107 11

<h4>Background</h4>Lifestyle changes are notoriously difficult. Since women who intend to become pregnant are more susceptible to lifestyle advice, interventions during this time window might be more effective than interventions during any other period in life. We here report the effects of the first large preconception lifestyle intervention RCT on diet and physical activity in obese infertile women.<h4>Methods</h4>In total, 577 women were randomized between a six-month lifestyle intervention p ...[more]

PMID: 30403756

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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.

Project description:BACKGROUND:The prevalence of obesity, an important cardiometabolic risk factor, is rising in women. Lifestyle improvements are the first step in treatment of obesity, but the success depends on factors like timing and motivation. Women are especially receptive to advice about lifestyle before and during pregnancy. Therefore, we hypothesize that the pre-pregnancy period provides the perfect window of opportunity to improve cardiometabolic health and quality of life of obese infertile women, by means of a lifestyle intervention. METHODS AND FINDINGS:Between 2009-2012, 577 infertile women between 18 and 39 years of age, with a Body Mass Index of ? 29 kg/m2, were randomized to a six month lifestyle intervention preceding infertility treatment, or to direct infertility treatment. The goal of the intervention was 5-10% weight loss or a BMI < 29 kg/m2. Cardiometabolic outcomes included weight, waist- and hip circumference, body mass index, systolic and diastolic blood pressure, fasting glucose and insulin, HOMA-IR, hs-CRP, lipids and metabolic syndrome. All outcomes were measured by research nurses at randomization, 3 and 6 months. Self-reported quality of life was also measured at 12 months. Three participants withdrew their informed consent, and 63 participants discontinued the intervention program. Intention to treat analysis was conducted. Mixed effects regression models analyses were performed. Results are displayed as estimated mean differences between intervention and control group. Weight (-3.1 kg 95% CI: -4.0 to -2.2 kg; P < .001), waist circumference (-2.4 cm 95% CI: -3.6 to -1.1 cm; P < .001), hip circumference (-3.0 95% CI: -4.2 to -1.9 cm; P < .001), BMI (-1.2 kg/m2 95% CI: -1.5 to -0.8 kg/m2; P < .001), systolic blood pressure (-2.8 mmHg 95% CI: -5.0 to -0.7 mmHg; P = .01) and HOMA-IR (-0.5 95% CI: -0.8 to -0.1; P = .01) were lower in the intervention group compared to controls. Hs-CRP and lipids did not differ between groups. The odds ratio for metabolic syndrome in the intervention group was 0.53 (95% CI: 0.33 to 0.85; P < .01) compared to controls. Physical QoL scores were higher in the lifestyle intervention group (2.2 95% CI: 0.9 to 3.5; P = .001) while mental QoL scores did not differ. CONCLUSIONS:In obese infertile women, a lifestyle intervention prior to infertility treatment improves cardiometabolic health and self-reported physical quality of life (LIFEstyle study: Netherlands Trial Register: NTR1530).

Project description:Lifestyle modification is recommended in women with polycystic ovary syndrome (PCOS) prior to conception but there are few randomized trials to support its implementation or benefit.This study aimed to determine the relative efficacy of preconception intervention on reproductive and metabolic abnormalities in overweight/obese women with PCOS.This was a randomized controlled trial of preconception and infertility treatment at Academic Health Centers in women with infertility due to PCOS, age 18-40 y and body mass index 27-42 kg/m(2).Women were randomly assigned to receive either 16 weeks of 1) continuous oral contraceptive pills (OCPs) (ethinyl estradiol 20 mcg/1 mg norethindrone acetate) ("OCP"); 2) lifestyle modification consisting of caloric restriction with meal replacements, weight loss medication (either sibutramine, or orlistat), and increased physical activity to promote a 7% weight loss ("Lifestyle"); or 3) combined treatment with both OCP and lifestyle modification ("Combined"). After preconception intervention, women underwent standardized ovulation induction with clomiphene citrate and timed intercourse for four cycles. Pregnancies were followed with trimester visits until delivery.Weight, ovulation, and live birth were measured.We consented 216 and randomly assigned 149 women (Lifestyle: n = 50; OCP: n = 49; Combined: n = 50). We achieved significant weight loss with both Lifestyle (mean weight loss, -6.2%; 95% confidence interval (CI), -7.4--5.0; and Combined (mean weight loss, -6.4%; 95% CI, -7.6--5.2) compared with baseline and OCP (both P < .001). There was a significant increase in the prevalence of metabolic syndrome at the end of preconception treatment compared with baseline within OCP (odds ratio [OR, 2.47; 95% CI, 1.42-4.27) whereas no change in metabolic syndrome was detected in the Lifestyle (OR, 1.18; 95% CI, 0.63-2.19) or Combined (OR, 0.72; 95% CI, 0.44-1.17) groups. Cumulative ovulation rates were superior after weight loss: OCP, 46%; Lifestyle, 60%; and Combined, 67% (P < .05). Live birth rates were OCP, 12%; Lifestyle, 26%; and Combined, 24% (P = .13).A preconception weight loss intervention eliminates the adverse metabolic oral contraceptive effects and, compared with oral contraceptive pretreatment, leads to higher ovulation rates.

Project description:BACKGROUND:The preconceptional period may be an optimal window of opportunity to improve lifestyle. We previously showed that a 6?month preconception lifestyle intervention among women with obesity and infertility was successful in decreasing the intake of high caloric snacks and beverages, increasing physical activity and in reducing weight in the short term. We now report the effects of the preconception lifestyle intervention on diet, physical activity and body mass index (BMI) at 5.5?years (range?=?3.7-7.0?years) after the intervention. METHODS:We followed women who participated in the LIFEstyle study, a multicentre RCT in which women with obesity and infertility were assigned to a six-month lifestyle intervention program or prompt infertility treatment (N?=?577). Diet and physical activity 5.5?years later were assessed with an 173-item food frequency questionnaire (N?=?175) and Actigraph triaxial accelerometers (N?=?155), respectively. BMI was calculated from self-reported weight and previously measured height (N?=?179). Dietary intake, physical activity, and BMI in the intervention and control group were compared using multivariate regression models. Additionally, dietary intake, physical activity and BMI of women allocated to the intervention arm with successful weight loss during the intervention (i.e. BMI?<?29?kg/m2 or???5% weight loss), unsuccessful weight loss and the control group were compared with ANCOVA. RESULTS:Although BMI did not differ between the intervention and control group 5.5?years after the intervention (-?0.5?kg/m2 [-?2.0;1.1]; P?=?0.56), the intervention group did report a lower energy intake (-?216?kcal/day [-?417;-16]; P?=?0.04). Women in the intervention arm who successfully lost weight during the intervention had a significantly lower BMI at follow-up compared to women in the intervention arm who did not lose weight successfully (-?3.4?kg/m2 [-?6.3;-0.6]; P?=?0.01), and they reported a significantly lower energy intake compared to the control group (-?301?kcal [-?589;-14]; P?=?0.04). Macronutrient intake, diet quality, and physical activity did not differ between the intervention and control group, irrespective of successful weight loss during the intervention. CONCLUSIONS:In our study population, a preconception lifestyle intervention led to reduced energy intake 5.5?years later. Additionally, women allocated to the intervention group who were successful in losing weight during the intervention also had a lower BMI at follow-up. This shows the potential sustainable effect of a preconception lifestyle intervention. TRIAL REGISTRATION:This trial was registered on 16 November 2008 in the Dutch trial register; clinical trial registry number NTR1530 .

Project description:BackgroundObesity in infertile women increases the costs of fertility treatments, reduces their effectiveness and increases significantly the risks of many complications of pregnancy and for the newborn. Studies suggest that even a modest loss of 5-10 % of body weight can restore ovulation. However, there are gaps in knowledge regarding the benefits and cost-effectiveness of a lifestyle modification program targeting obese infertile women and integrated into the fertility clinics. This study will evaluate clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women. We hypothesize that the intervention will: 1) improve fertility, efficacy of fertility treatments, and health of mothers and their children; and 2) reduce the cost per live birth, including costs of fertility treatments and pregnancy outcomes.Methods/designObese infertile women (age: 18-40 years; BMI ≥30 kg/m(2) or ≥27 kg/m(2) with polycystic ovary syndrome) will be randomised to either a lifestyle intervention followed by standard fertility treatments after 6 months if no conception has been achieved (intervention group) or standard fertility treatments only (control group). The intervention and/or follow-up will last for a maximum of 18 months or up to the end of pregnancy. Evaluation visits will be planned every 6 months where different outcome measures will be assessed. The primary outcome will be live-birth rates at 18 months. The secondary outcomes will be sub-divided into four categories: lifestyle and anthropometric, fertility, pregnancy complications, and neonatal outcomes. Outcomes and costs will be also compared to similar women seen in three fertility clinics across Canada. Qualitative data will also be collected from both professionals and obese infertile women.DiscussionThis study will generate new knowledge about the implementation, impacts and costs of a lifestyle management program in obese infertile women. This information will be relevant for decision-makers and health care professionals, and should be generalizable to North American fertility clinics.Trial registrationClinicalTrials.gov NCT01483612. Registered 25 November 2011.

Dataset Information

Effects of a preconception lifestyle intervention in obese infertile women on diet and physical activity; A secondary analysis of a randomized controlled trial.

Background

Methods

Results

Conclusion

Publications

Effects of a preconception lifestyle intervention in obese infertile women on diet and physical activity; A secondary analysis of a randomized controlled trial.

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