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Effect of a Nutritional and Behavioral Intervention on Energy-Reduced Mediterranean Diet Adherence Among Patients With Metabolic Syndrome: Interim Analysis of the PREDIMED-Plus Randomized Clinical Trial.
Sayón-Orea, C, Razquin, C, Bulló, M, Corella, D, Fitó, M, Romaguera, D, Vioque, J, Alonso-Gómez, ÁM, Wärnberg, J, Martínez, JA, et al
JAMA. 2019;322(15):1486-1499
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Excess caloric intake and poor nutritional quality are associated with overweight and obesity. A traditional Mediterranean diet has been shown to reduce all-cause mortality, and in particular to reduce risk of cardiovascular disease, type 2 diabetes mellitus and overweight. The aim of this randomised, prospective, single-blinded study was to evaluate the effectiveness of an intensive lifestyle intervention programme in 6874 overweight or obese men and women with metabolic syndrome in Spain. The intervention group was advised on an energy-reduced Mediterranean diet and exercise and received behavioural support, with initial group sessions and interviews, and monthly follow-up phone calls for one year. The control group received advice on a Mediterranean diet and usual care, with 6 monthly follow-ups. After 12 months, the more intensively counselled patients showed a significantly better adherence to an energy-reduced Mediterranean diet than the control group. They had greater reductions in refined grains, pastries, red and processed meats and greater increases in vegetable, fruit and nut consumption than the control group. The intervention group had also better improvements in cardiovascular risk factors.
Abstract
Importance: High-quality dietary patterns may help prevent chronic disease, but limited data exist from randomized trials about the effects of nutritional and behavioral interventions on dietary changes. Objective: To assess the effect of a nutritional and physical activity education program on dietary quality. Design, Setting, and Participants: Preliminary exploratory interim analysis of an ongoing randomized trial. In 23 research centers in Spain, 6874 men and women aged 55 to 75 years with metabolic syndrome and no cardiovascular disease were enrolled in the trial between September 2013 and December 2016, with final data collection in March 2019. Interventions: Participants were randomized to an intervention group that encouraged an energy-reduced Mediterranean diet, promoted physical activity, and provided behavioral support (n = 3406) or to a control group that encouraged an energy-unrestricted Mediterranean diet (n = 3468). All participants received allotments of extra-virgin olive oil (1 L/mo) and nuts (125 g/mo) for free. Main Outcomes and Measures: The primary outcome was 12-month change in adherence based on the energy-reduced Mediterranean diet (er-MedDiet) score (range, 0-17; higher scores indicate greater adherence; minimal clinically important difference, 1 point). Results: Among 6874 randomized participants (mean [SD] age, 65.0 [4.9] years; 3406 [52%] men), 6583 (96%) completed the 12-month follow-up and were included in the main analysis. The mean (SD) er-MedDiet score was 8.5 (2.6) at baseline and 13.2 (2.7) at 12 months in the intervention group (increase, 4.7 [95% CI, 4.6-4.8]) and 8.6 (2.7) at baseline and 11.1 (2.8) at 12 months in the control group (increase, 2.5 [95% CI, 2.3-2.6]) (between-group difference, 2.2 [95% CI, 2.1-2.4]; P < .001). Conclusions and Relevance: In this preliminary analysis of an ongoing trial, an intervention that encouraged an energy-reduced Mediterranean diet and physical activity, compared with advice to follow an energy-unrestricted Mediterranean diet, resulted in a significantly greater increase in diet adherence after 12 months. Further evaluation of long-term cardiovascular effects is needed. Trial Registration: isrctn.com Identifier: ISRCTN89898870.
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A 12-Month Lifestyle Intervention Program Improves Body Composition and Reduces the Prevalence of Prediabetes in Obese Patients.
König, D, Hörmann, J, Predel, HG, Berg, A
Obesity facts. 2018;11(5):393-399
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Obesity and its impact on the prevalence of diabetes and subsequent cardiovascular disease is one of the major health burdens in Western societies. Lifestyle intervention studies have shown that weight loss combined with increased physical activity can improve metabolic risk factors. The aim of this study was to evaluate the effect of a comprehensive lifestyle intervention programme on weight and metabolic risk factors in 5884 obese individuals. The programme included 61 sessions over 12 months, including 41 exercise sessions, 12 psychological/self-management sessions and 8 nutritional counselling sessions (based on a low glycaemic index, low fat diet). After 12 months there was a significant reduction in weight (average 6%), waist circumference, physical fitness and all metabolic parameters (including blood sugar and fat metabolism). Overall, in 839 (38%) of the 2,227 participants who were pre-diabetic before intervention, the criteria of pre-diabetes were no longer detectable after 12 months, whilst only 66 (3%) progressed to type 2 diabetes mellitus. 46.7% of the 1,641 participants fulfilling the criteria of metabolic syndrome before the intervention, did not show any signs of this syndrome after the intervention; whilst only 120 participants (+7.3%) newly developed metabolic syndrome. The authors concluded that the intensive lifestyle intervention programme was successful, even in obese people with pre-diabetes.
Abstract
BACKGROUND The present study investigated the effects of a 12-month interdisciplinary standardized lifestyle program addressing physical activity and changes in dietary and lifestyle behavior in 2,227 obese prediabetic participants. METHODS Measures of obesity (BMI, waist circumference), cardiopulmonary fitness, and metabolic parameters were determined before and after the intervention period. RESULTS From the 2,227 participants who were initially prediabetic, 839 participants (-37.7%) did no longer show the criteria of prediabetes after the intervention and had normal HbA1c levels. CONCLUSION The clinical effects are substantial, and it is likely that the applied intense and multidisciplinary lifestyle interventions could reduce the risk of developing diabetes and the prevalence of a full-blown metabolic syndrome in obese and prediabetic patients.
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Effect of a lifestyle intervention in obese infertile women on cardiometabolic health and quality of life: A randomized controlled trial.
van Dammen, L, Wekker, V, van Oers, AM, Mutsaerts, MAQ, Painter, RC, Zwinderman, AH, Groen, H, van de Beek, C, Muller Kobold, AC, Kuchenbecker, WKH, et al
PloS one. 2018;13(1):e0190662
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Obesity is linked to increase in cardiovascular and related disease risk factors. The rate of prevalence of obesity in childbearing women is on the increase. Based on these data one of the largest randomised control multicentre Lifestyle study was conducted. The aim of this study was to look into the effects of lifestyle intervention on cardio metabolic risk factors in childbearing obese women. The intervention goal was weight loss of 5-10% within six month. The intervention included caloric restriction and moderate physical activity. The result from the study showed lifestyle intervention among obese infertile women improved cardio metabolic health and also their physical quality of life. The authors concluded that based on data from this study infertile obese women, especially prior to infertility treatment, should be informed of the positive effects of lifestyle intervention of diet and physical activity.
Abstract
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).