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Representativeness of participants in a lifestyle intervention study in obese pregnant women - the difference between study participants and non-participants.

ABSTRACT: To examine the representativeness of participants attending a lifestyle intervention study addressing obese pregnant women.Retrospective comparison of baseline data, attendance to oral glucose tolerance test (OGTT) during pregnancy, and pregnancy outcome in eligible women stratified according to study participation. Of 750 eligible women with a self-reported BMI > 30 kg/m(2), and a live singleton pregnancy, 510 were eligible for inclusion and 425 were randomized to either active intervention (n= 284) or to standard obstetric care (n= 141) including two standard OGTT. The 85 women who declined participation or were excluded due to competing diseases and 240 women who did not respond to the initial invitation received the same standard care.The randomized women had similar BMI but a lower parity and age, and were more frequently non-smokers, born in Denmark and married or cohabitating with their partner than the non-participants. Women participating in the trial had a higher compliance to the second OGTT compared to non-participants, also after correcting for age and nationality. There was no difference in pregnancy outcome, i.e., fetal weight and length, gestational age as well as mode of delivery.Women declining participation in a randomized lifestyle intervention study in pregnancy have characteristics indicating they are those who might benefit the most from lifestyle intervention.

SUBMITTER: Gesche J

PROVIDER: S-EPMC5644893 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Representativeness of participants in a lifestyle intervention study in obese pregnant women - the difference between study participants and non-participants.

Gesche Joanna J Renault Kristina K Nørgaard Kirsten K Nilas Lisbeth L

Obesity facts 20141125 6

<h4>Objective</h4>To examine the representativeness of participants attending a lifestyle intervention study addressing obese pregnant women.<h4>Methods</h4>Retrospective comparison of baseline data, attendance to oral glucose tolerance test (OGTT) during pregnancy, and pregnancy outcome in eligible women stratified according to study participation. Of 750 eligible women with a self-reported BMI > 30 kg/m(2), and a live singleton pregnancy, 510 were eligible for inclusion and 425 were randomized ...[more]

PMID: 25428213

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Project description:BackgroundThe Mighty Mums antenatal lifestyle intervention is a person-centered behavioral intervention focusing on nutrition and physical activity for pregnant women with obesity (body mass index [BMI] ≥30). The aim of this study was to evaluate the costs and clinical outcomes of adding the Mighty Mums intervention to standard antenatal care.MethodsParticipants in the intervention group (n = 434) received motivational talks with their midwife and a selection of physical and/or nutritional activities in addition to antenatal care. Control participants (n = 867) from adjacent geographic areas received standard antenatal care. Costs for staff, unit costs for specific activities, and registered costs for specialized antenatal care were analyzed for associations with gestational weight gain and self-reported health. Results are reported for the intention-to-treat (ITT) population and a per protocol (PP) population identified by participation in the intervention. Analyses included bootstrapped linear regressions adjusted for background characteristics that differed significantly between groups.ResultsThe average costs were SEK 9727 higher (95% confidence interval [CI]: 6677 to 12,777) among participants in the intervention group than in the control ITT population and SEK 8655 (95% CI 4586 to 12,724) higher than in the PP population. The cost increase per 1 kg reduction in gestational weight gain was SEK 12,369 in the ITT population and SEK 7209 for the PP population.ConclusionParticipation in the Mighty Mums intervention was associated with higher costs, but also reduced gestational weight gain. The cost per kilogram reduction in gestational weight gain was low, particularly in the PP population. A future decision to implement this behavioral intervention in standard care should take into account society's willingness to pay per unit reduction in gestational weight gain.Trial registrationThe study is registered at ClinicalTrials.gov , Identifier: NCT03147079 .

Project description:The proportion of women entering pregnancy overweight or obese has been rising and, in turn, is associated with adverse maternal and fetal outcomes. Gestational weight gain (GWG) exceeding Institute of Medicine (IOM) guidelines further increases health risks and has been independently associated with postpartum weight retention. Hispanic women are disproportionately affected by overweight and obesity, but have had limited access to interventions that promote healthy lifestyles due to cultural, socioeconomic, and language barriers. Therefore, the overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce excess GWG, increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.Overweight/obese Hispanic women are recruited in early pregnancy and randomly assigned to a Lifestyle Intervention (n = 150) or a Comparison Health and Wellness (control) intervention (n = 150). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) are used to deliver the intervention from early pregnancy (12 weeks gestation) to 6 months postpartum, with follow-up to 1 year postpartum. Targets of the intervention are to achieve IOM Guidelines for GWG and postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies to address the specific social, cultural, and economic challenges faced by low-income Hispanic women. Assessments are conducted at baseline (~10 weeks gestation), mid pregnancy (24-28 weeks gestation), late pregnancy (32-34 weeks gestation) and postpartum at 6-weeks, 6-months, and 12-months by bicultural and bilingual personnel blinded to the intervention arm. Efficacy is assessed via GWG, postpartum weight loss, and biomarkers of glycemic control, insulin resistance, and cardiovascular disease risk factors. Changes in physical activity and diet are measured via 7-day accelerometer data and 24-h dietary recalls at each assessment time period.Hispanic women are the fastest growing minority group in the U.S. and are disproportionately affected by overweight and obesity. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations.NCT01868230 May 29, 2013.

Project description:BackgroundLifestyle interventions for obese pregnant women have been widely researched but little is known about predictors of low adherence or poor outcomes. This study evaluated the prospective associations between elevated symptoms of antenatal depression and gestational diabetes, adherence and gestational weight gain in a large RCT of a behavioural intervention for obese pregnant women. The effect of the intervention on symptoms of depression at follow-up was also examined.MethodsThe UPBEAT RCT randomised 1555 obese pregnant women to receive a dietary and physical activity lifestyle intervention or standard care. Symptoms of antenatal depression were assessed with the Edinburgh Postnatal Depression Scale at baseline (15+?0-18+?6 weeks' gestation) and follow-up (27+?0-28+?6 weeks' gestation). Gestational diabetes was assessed with an oral glucose tolerance test at 27+?0-28+?6 weeks' gestation. Adherence was pre-defined as receiving at least 5 of 8 intervention sessions. Gestational weight gain was calculated as the difference between pre-pregnancy weight (estimated as measured baseline weight minus 1.25 kg) and last measured weight at 34+?0-36+?0 weeks' gestation. Due to substantial missing data in certain variables, multiple imputation was used to impute missing data. Women who were no longer pregnant at 27+?0-28+?6 weeks' gestation were excluded from the sample for these analyses.ResultsOne thousand five-hundered twenty-six women were included in these analyses following multiple imputation; 797 (52.2%) had complete data. 13.4% had elevated symptoms of antenatal depression at baseline. There was no evidence for associations between antenatal depression status and gestational diabetes (adjusted OR 0.80, 95%CI 0.52 to 1.22, p?=?0.30), adherence (adjusted OR 1.16, 95%CI 0.63 to 2.15, p?=?0.63) or gestational weight gain (adjusted regression coefficient 0.52, 95%CI -0.26 to 1.29, p?=?0.19). The intervention was not associated with change in depressive symptoms at follow-up (regression coefficient 0.003, 95%CI -0.49 to 0.49, p?=?0.99). Similar results were obtained in complete case analyses.ConclusionsElevated symptoms of antenatal depression did not predict gestational diabetes, adherence or gestational weight gain in this large RCT of a lifestyle intervention for obese pregnant women. The intervention also did not influence symptoms of depression at follow-up. Obese pregnant women with elevated symptoms of depression should not be excluded from lifestyle interventions.Trial registrationISRCTN89971375 . Registered 28 November 2008.

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Representativeness of participants in a lifestyle intervention study in obese pregnant women - the difference between study participants and non-participants.

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Representativeness of participants in a lifestyle intervention study in obese pregnant women - the difference between study participants and non-participants.

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