Effect of a lifestyle intervention in obese infertile women on cardiometabolic health and quality of life: A randomized controlled trial

摘要

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. As women are especially receptive to lifestyle advice before and during pregnancy, this intervention could be more successful than lifestyle interventions at any other time in the lifespan. Moreover, if successful, this intervention could not only affect cardiovascular health of women but that of their offspring as well. 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: Between 2009-2012, 577 infertile women between 18 and 39 years of age, with a Body Mass Index of ≥ 29 kg/m~2, were randomized to a six month lifestyle intervention preceding infertility treatment, or to prompt infertility treatment (LIFEstyle study: Netherlands Trial Register: NTR1530). The goal of the intervention was 5-10% weight loss or a BMI < 29kg/m~2. 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. Mixed effects regression models analyses were performed. Results: Results are displayed as estimated mean differences between intervention and control group. Weight (-3.1 kg 95% CI: -4.0 - -2.2kg; P<.001), waist circumference (-2.4cm 95% CI: -3.6 - -1.1 cm; P < .001), hip circumference (-3.0 95% CI: -4.2 --1.9cm; P<.001), BMI (-1.2kg/m~2 95% CI: -1.5 - -0.8kg/m~2; P<.001), systolic blood pressure (-2.8mmHg 95% CI: -5.0 --0.7mmHg; P = .01) and HOMA-IR (-0.5 95% CI: -0.8 - -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: 0.33-0.85; P < .01) compared to controls. Physical QoL scores were higher in the lifestyle intervention group (2.2 95% CI: 0.9-3.5; 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. We are currently assessing the long term effects of the intervention on health of the women and the children that were conceived during this trial (http://www.WOMB-project.eu).