Dataset Information

Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial.

ABSTRACT:

Background

Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity.

Methods

We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2).

Results

Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p < 0.001) and saturated fat intake (-1.6% energy, 95% CI -2.8 to -0. 3) at 28 weeks' gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery.

Conclusions

This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT.

Trial registration

Trial registration number

ISRCTN89971375.

SUBMITTER: Poston L

PROVIDER: S-EPMC3718630 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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Publications

Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial.

Poston Lucilla L Briley Annette L AL Barr Suzanne S Bell Ruth R Croker Helen H Coxon Kirstie K Essex Holly N HN Hunt Claire C Hayes Louise L Howard Louise M LM Khazaezadeh Nina N Kinnunen Tarja T Nelson Scott M SM Oteng-Ntim Eugene E Robson Stephen C SC Sattar Naveed N Seed Paul T PT Wardle Jane J Sanders Thomas A B TA Sandall Jane J

BMC pregnancy and childbirth 20130715

<h4>Background</h4>Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity.<h4>Methods</h4>We undertook a ...[more]

PMID: 23855708

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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.

Project description:BackgroundPregnancy is associated with widespread change in metabolism, which may be more marked in obese women. Whether lifestyle interventions in obese pregnant women improve pregnancy metabolic profiles remains unknown. Our objectives were to determine the magnitude of change in metabolic measures during obese pregnancy, to indirectly compare these to similar profiles in a general pregnant population, and to determine the impact of a lifestyle intervention on change in metabolic measures in obese pregnant women.MethodsData from a randomised controlled trial of 1158 obese (BMI ??30 kg/m2) pregnant women recruited from six UK inner-city obstetric departments were used. Women were randomised to either the UPBEAT intervention, a tailored complex lifestyle intervention focused on improving diet and physical activity, or standard antenatal care (control group). UPBEAT has been shown to improve diet and physical activity during pregnancy and up to 6-months postnatally in obese women and to reduce offspring adiposity at 6-months; it did not affect risk of gestational diabetes (the primary outcome). Change in the concentrations of 158 metabolic measures (129 lipids, 9 glycerides and phospholipids, and 20 low-molecular weight metabolites), quantified three times during pregnancy, were compared using multilevel models. The role of chance was assessed with a false discovery rate of 5% adjusted p values.ResultsAll very low-density lipoprotein (VLDL) particles increased by 1.5-3 standard deviation units (SD) whereas intermediate density lipoprotein and specific (large, medium and small) LDL particles increased by 1-2 SD, between 16 and 36 weeks' gestation. Triglycerides increased by 2-3 SD, with more modest changes in other metabolites. Indirect comparisons suggest that the magnitudes of change across pregnancy in these obese women were 2- to 3-fold larger than in unselected women (n = 4260 in cross-sectional and 583 in longitudinal analyses) from an independent, previously published, study. The intervention reduced the rate of increase in extremely large, very large, large and medium VLDL particles, particularly those containing triglycerides.ConclusionThere are marked changes in lipids and lipoproteins and more modest changes in other metabolites across pregnancy in obese women, with some evidence that this is more marked than in unselected pregnant women. The UPBEAT lifestyle intervention may contribute to a healthier metabolic profile in obese pregnant women, but our results require replication.Trial registrationUPBEAT was registered with Current Controlled Trials, ISRCTN89971375 , on July 23, 2008 (prior to recruitment).

Project description:BackgroundMaternal obesity and rapid infant weight gain have been associated with increased risk of obesity in childhood. Breastfeeding is suggested to be protective against childhood obesity, but no previous study has addressed the potential benefit of breastfeeding as a preventive method of childhood obesity amongst obese women. The primary aim of this study was to assess the relationship between mode of feeding and body composition, growth and eating behaviours in 6-month-old infants of obese women who participated in UPBEAT; a multi-centre randomised controlled trial comparing a lifestyle intervention of diet and physical activity to standard care during pregnancy.MethodsThree hundred and fifty-three mother and infant pairs attended a 6-months postpartum follow-up visit, during which they completed the Baby-Eating Behaviour Questionnaire, a parent-reported psychometric measure of appetite traits. Measures of infant body composition were also undertaken. As there was no effect of the antenatal intervention on infant feeding and appetite the study was treated as a cohort. Using regression analyses, we examined relationships between: 1) mode of feeding and body composition and growth; 2) mode of feeding and eating behaviour and 3) eating behaviour and body composition.ResultsFormula fed infants of obese women in comparison to those exclusively breastfed, demonstrated higher weight z-scores (mean difference 0.26; 95% confidence interval 0.01 to 0.52), higher rate of weight gain (0.04; 0.00 to 0.07) and greater catch-up growth (2.48; 1.31 to 4.71). There was also a lower enjoyment of food (p?=?0.002) amongst formula fed infants, following adjustment for confounders. Independent of the mode of feeding, a measure of infant appetite was associated with sum of skinfold thicknesses (? 0.66; 95% CI 0.12 to 1.21), calculated body fat percentage (0.83; 0.15 to 1.52), weight z-scores (0.21; 0.06 to 0.36) and catch-up growth (odds ratio 1.98; 1.21 to 3.21).ConclusionsIn obese women, exclusive breastfeeding was protective against increasing weight z-scores and trajectories of weight gain in their 6-month old infants. Measures of general appetite in early infancy were associated with measures of adiposity, weight and catch up growth independent of cord blood leptin concentrations and mode of early feeding.

Project description:ObjectivesTo assess, in terms of self-efficacy in weight management, the effectiveness of the SLIM lifestyle intervention among overweight or obese women during pregnancy and after delivery, and further to exploit machine learning and event mining approaches to build personalized models. Additionally, the aim is to evaluate the implementation of the SLIM intervention.MethodsThis prospective trial, which is a non-randomized, quasi-experimental, pre-post intervention, includes an embedded mixed-method process evaluation. The SLIM Intervention is delivered by public health nurses (n = 9) working in maternity clinics. The public health nurses recruited overweight women (n = 54) at their first antenatal visit using convenience sampling. The core components of the intervention i.e. health technology, motivational interviewing, feedback, and goal setting, are utilized in antenatal visits in maternity clinics starting from gestational week 15 or less and continuing to 12 weeks after delivery. Mixed effect models are used to evaluate change over time in self-efficacy, weight management and weight change. Simple mediation models are used to assess calories consumed and moderate to vigorous physical activity (MVPA) as mediators between self-efficacy and weight change. Signal processing and machine learning techniques are exploited to extract events from the data collected via the Oura ring and smartphone-based questionnaires.DiscussionThe SLIM intervention was developed in collaboration with overweight women and public health nurses working in maternity clinics. This study evaluates the effectiveness of the intervention among overweight women in increasing self-efficacy and achieving a healthy weight; thus, impacting the healthy lifestyle and long-term health of the whole family. The long-term objective is to contribute to women's health by supporting weight-management through behavior change via interventions conducted in maternity clinics.Trial registrationThe trial was registered at the Clinicaltrials.gov register platform (ID NCT04826861) on 17 March 2021.

Project description:BackgroundMaternal antenatal depression is associated with offspring psychological disorders, but obesity is also widely implicated in maternal depression and neurodevelopment. In pregnant women with obesity we explored interrelationships between antenatal depressive symptom trajectories and multiple exposures implicated in fetal neurodevelopment which could explain these associations, as a prelude to exploring associations with infant mental health.MethodsThe UK Pregnancies Better Eating and Activity Trial (UPBEAT) recruited multi-ethnic pregnant women with obesity (BMI >= 30kg/m2) between March 2009 and June 2014 from 8 UK sites and 1369 were included to model longitudinal antenatal depressive symptoms from Edinburgh Postnatal Depression Scale (EPDS) scores using Latent Class Growth Analysis. Classes were compared on maternal baseline demography, biomarkers of metabolism, inflammation and placental function, infection, diet and by pregnancy and birth outcomes. Odds ratios, mean differences and 95% Confidence Intervals were calculated using robust auxiliary modelling techniques.FindingsThe chosen model produced four classes: "Not Depressed" (n=575 [42%], "reference"), "Mild" (n=523 [37·5%]), "Moderate" (n=219 [16%]) and "Severe" (n=62 [4·5%]) symptom trajectories. Socio-economic deprivation and ethnic diversity were greater in Severe and Moderate classes. Dietary glycaemic load and saturated fat intake were higher in Severe and Moderate classes (at 17 and 27 weeks). Higher Interleukin-6, glycoprotein acetyls (17 weeks), glucose (34 weeks) and lower placental growth factor (PlGF, 17 and 27 weeks) was found in the Severe class. PlGF was lower in the Moderate class (27 weeks). Infection was least likely in the Not Depressed class across gestation. Risks of preterm birth were associated with Severe depressive symptoms (aOR 3·05[1·11 to 8·36]).InterpretationComprehensive phenotyping exposes important fetal exposures implicated in adverse neurodevelopment, differing by depression class. This study expands substantially on causal models of suboptimal fetal neurodevelopment and offers potential new targets for intervention in obese pregnant women.FundingJNS was funded by a PhD studentship from the National Institute for Health Research (NIHR) Biomedical Research Centre based at Guy's and St Thomas' NHS Foundation Trust and King's College London. UPBEAT was supported by the European Union's 7th Framework Programme (FP7/2007-2013), project EarlyNutrition; grant agreement no. 289346 and the National Institute for Health Research (NIHR) (UK) Programme Grants for Applied Research Programme (RP-0407-10452), Medical Research Council UK Project Grant (MR/L002477/1). Support was also provided by the Chief Scientist Office Scotland, Guy's and St Thomas' Charity and Tommy's Charity (Registered charity no. 1060508). LP and SLW are funded by Tommy's Charity.

Dataset Information

Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Trial registration number

Publications

Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial.

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