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Cost-utility analysis of a randomized controlled weight loss trial among lactating overweight/obese women.

ABSTRACT: Overweight and obesity among young, adult women are increasing problems in Sweden as in many other countries. The postpartum period may be a good opportunity to improve eating habits and lose weight in a sustainable manner. The aim was to make a cost-utility analysis of a dietary behavior modification treatment alongside usual care, compared to usual care alone, among lactating overweight and obese women.This study was a cost-utility analysis based on a randomized controlled and longitudinal clinical diet intervention. Between 2007-2010, 68 women living in Sweden were, after baseline measurement at 8-12 weeks postpartum, randomly assigned to a 12-week dietary behavior modification treatment or control group. Inclusion criteria were: self-reported pre-pregnancy body mass index (BMI) 25-35 kg/m2, non-smoker, singleton term delivery, birth weight?>?2500 g, intention to breastfeed for 6 mo and no diseases (mother and child). The women in the intervention group received 1.5 hour of individual counseling at study start and 1 hour at follow-up home visits after 6 weeks of intervention, with support through cell phone text messages every two wk. Dietary intervention aimed to reduce dietary intake by 500 kcal/day. The control group received usual care. Weight results have previously been reported. Here we report on analyses carried out during 2012-2013 of cost per quality adjusted life years (QALY), based on the changes in quality of life measured by EQ-5D-3 L and SF-6D. Likelihood of cost-effectiveness was calculated using Net Monetary Benefit method.Based on conservative assumptions of no remaining effect after 1 year follow-up, the diet intervention was cost-effective. Costs per gained QALY were 8 643 - 9 758 USD. The likelihood for cost-effectiveness, considering a willingness to pay 50 000 USD for a QALY, was 87-93%.The diet intervention is cost-effective.ClinicalTrials.gov Identifier: NCT01343238 Registered April 27, 2011.The regional ethics committee in Gothenburg, Sweden, approved the study on November 15, 2006.

SUBMITTER: Hagberg LA

PROVIDER: S-EPMC3910238 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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Cost-utility analysis of a randomized controlled weight loss trial among lactating overweight/obese women.

Hagberg Lars A LA Brekke Hilde K HK Bertz Fredrik F Winkvist Anna A

BMC public health 20140115

<h4>Background</h4>Overweight and obesity among young, adult women are increasing problems in Sweden as in many other countries. The postpartum period may be a good opportunity to improve eating habits and lose weight in a sustainable manner. The aim was to make a cost-utility analysis of a dietary behavior modification treatment alongside usual care, compared to usual care alone, among lactating overweight and obese women.<h4>Methods</h4>This study was a cost-utility analysis based on a randomi ...[more]

PMID: 24428802

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Project description:ObjectiveAs there is significant heterogeneity in the weight loss response to pharmacotherapy, one of the most important clinical questions in obesity medicine is how to predict an individual's response to pharmacotherapy. The present study examines patterns of weight loss among overweight and obese women who demonstrated early robust response to twice daily exenatide treatment compared to those treated with hypocaloric diet and matched placebo injections.MethodsWe randomized 182 women (BMI 25-48 kg/m2) to treatment with exenatide alone or matched placebo injections plus hypocaloric diet. In both treatment groups, women who demonstrated ≥ 5% weight loss at 12 weeks were characterized as high responders and those who lost ≥10% of body weight were classified as super responders. Our primary outcome was long-term change in body weight among early high responders to either treatment. An exploratory metabolomic analysis was also performed.ResultsWe observed individual variability in weight loss with both exenatide and hypocaloric diet plus placebo injections. There was a trend toward a higher percentage of subjects who achieved ≥ 5% weight loss with exenatide compared to diet (56% of those treated with exenatide, 76% of those treated with diet, p = 0.05) but no significant difference in those who achieved ≥ 10% weight loss (23% of individuals treated with exenatide and 36% of those treated with diet, p = 0.55). In both treatment groups, higher weight loss at 3 months of treatment predicted super responder status (diet p=0.0098, exenatide p=0.0080). Both treatment groups also demonstrated similar peak weight loss during the study period. We observed lower cysteine concentrations in the exenatide responder group (0.81 vs 0.48 p < 0.0001) and a trend toward higher levels of serotonin, aminoisobutyric acid, anandamide, and sarcosine in the exenatide super responder group.ConclusionIn a population of early high responders, longer term weight loss with exenatide treatment is similar to that achieved with a hypocaloric diet.Clinical trial registrationwww.clinicaltrialsgov, identifier NCT01590433.

Project description:BackgroundObesity is an established and modifiable risk factor for urinary incontinence, but conclusive evidence for a beneficial effect of weight loss on urinary incontinence is lacking.MethodsWe randomly assigned 338 overweight and obese women with at least 10 urinary-incontinence episodes per week to an intensive 6-month weight-loss program that included diet, exercise, and behavior modification (226 patients) or to a structured education program (112 patients).ResultsThe mean (+/-SD) age of the participants was 53+/-11 years. The body-mass index (BMI) (the weight in kilograms divided by the square of the height in meters) and the weekly number of incontinence episodes as recorded in a 7-day diary of voiding were similar in the intervention group and the control group at baseline (BMI, 36+/-6 and 36+/-5, respectively; incontinence episodes, 24+/-18 and 24+/-16, respectively). The women in the intervention group had a mean weight loss of 8.0% (7.8 kg), as compared with 1.6% (1.5 kg) in the control group (P<0.001). After 6 months, the mean weekly number of incontinence episodes decreased by 47% in the intervention group, as compared with 28% in the control group (P=0.01). As compared with the control group, the intervention group had a greater decrease in the frequency of stress-incontinence episodes (P=0.02), but not of urge-incontinence episodes (P=0.14). A higher proportion of the intervention group than of the control group had a clinically relevant reduction of 70% or more in the frequency of all incontinence episodes (P<0.001), stress-incontinence episodes (P=0.009), and urge-incontinence episodes (P=0.04).ConclusionsA 6-month behavioral intervention targeting weight loss reduced the frequency of self-reported urinary-incontinence episodes among overweight and obese women as compared with a control group. A decrease in urinary incontinence may be another benefit among the extensive health improvements associated with moderate weight reduction. (ClinicalTrials.gov number, NCT00091988.)

Project description:BackgroundLittle is known about the effect of intentional weight loss and subsequent weight regain on cardiometabolic risk factors in older adults. The objective of this study was to determine how cardiometabolic risk factors change in the year following significant intentional weight loss in postmenopausal women, and if observed changes were affected by weight and fat regain.MethodsEighty, overweight and obese, older women (age = 58.8±5.1 years) were followed through a 5-month weight loss intervention and a subsequent 12-month nonintervention period. Body weight/composition and cardiometabolic risk factors (blood pressure; total, high-density lipoprotein, and low-density lipoprotein cholesterol; triglycerides; fasting glucose and insulin; and Homeostatic Model Assessment of Insulin Resistance) were analyzed at baseline, immediately postintervention, and 6- and 12-months postintervention.ResultsAverage weight loss during the 5-month intervention was 11.4±4.1kg and 31.4% of lost weight was regained during the 12-month follow-up. On average, all risk factor variables were significantly improved with weight loss but regressed toward baseline values during the year subsequent to weight loss. Increases in total cholesterol, triglycerides, glucose, insulin, and Homeostatic Model Assessment of Insulin Resistance during the postintervention follow-up were significantly (p < .05) associated with weight and fat mass regain. Among women who regained weight, model-adjusted total cholesterol (205.8±4.0 vs 199.7±2.9mg/dL), low-density lipoprotein cholesterol (128.4±3.4 vs 122.7±2.4mg/dL), insulin (12.6±0.7 vs 11.4±0.7mg/dL), and Homeostatic Model Assessment of Insulin Resistance (55.8±3.5 vs 50.9±3.7mg/dL) were higher at follow-up compared with baseline.ConclusionsFor postmenopausal women, even partial weight regain following intentional weight loss is associated with increased cardiometabolic risk. Conversely, maintenance of or continued weight loss is associated with sustained improvement in the cardiometabolic profile.

Project description:BackgroundObesity and cardiovascular diseases are increasing globally and any association between reproduction and these conditions is of concern. Unfortunately, little is known about normal levels of metabolic risk factors in women of different body mass index throughout the reproductive cycle. This study is one of the first to describe the metabolic risk profile of lactating overweight or obese women at 8-12 weeks postpartum.MethodsDuring 2007-2009, 66 overweight or obese Swedish lactating women without known diseases underwent detailed measurements of their metabolic profiles, dietary intake and general health before entering a lifestyle intervention trial. Baseline measurements took place between 8-12 wk postpartum. Almost all women were exclusively breastfeeding their term infants.ResultsThe women were regarded as healthy, as reflected in the absence of diagnosed diseases, their own perceptions and in normal hemoglobin, albumin and fasting plasma glucose values. Four women were diagnosed with metabolic syndrome. In these cases, underlying conditions included large waist circumference, low HDL cholesterol values, high triglyceride values and relatively high blood pressure. The metabolic profile differed between overweight and obese women; obese women had significantly higher levels of fasting insulin (p = 0.017), borderline higher HOMA values (p = 0.057) and significantly higher triglyceride values (p = 0.029), as well as larger waist and hip circumferences (p<0.001 and p<0.001). However, no significant differences between overweight and obese women were detected for LDL or total cholesterol levels. Overweight and obese women reported similar total energy and macronutrient intakes, but obese women tended to be less physically active (p = 0.081).ConclusionsAmong generally healthy lactating women, obesity as compared to overweight is associated with increased metabolic risk. This cut-off is thus important also in the early postpartum period, and obesity among these women should warrant proper health investigation. Macronutrient intake did not differ between the groups and, hence, cannot explain these differences.Trial registrationClinicalTrials.gov Identifier: NCT01343238.

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Cost-utility analysis of a randomized controlled weight loss trial among lactating overweight/obese women.

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Cost-utility analysis of a randomized controlled weight loss trial among lactating overweight/obese women.

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