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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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Plain language summary
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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Comparison of low calorie high protein and low calorie standard protein diet on waist circumference of adults with visceral obesity and weight cycling.
Witjaksono, F, Jutamulia, J, Annisa, NG, Prasetya, SI, Nurwidya, F
BMC research notes. 2018;11(1):674
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Obesity has become one of the world’s biggest health problem. Obese individuals with a history of repeated weight loss and regain (called weight cycling) have a higher risk of developing chronic disease and increased fat mass in every cycle. The objective of the study was to evaluate the effect of a low calorie high protein diet compared to a low calorie standard protein diet on waist circumference in adults with visceral obesity. The open, randomised clinical trial recruited 61 obese subjects who are older than 20 years of age and had a history of weight cycling. Participants were randomly assigned to one of the two diet groups; high protein or standard protein. Results showed that following a low-calorie diet resulted in waist circumference reduction thus reducing visceral fat. However, protein composition in the diet plan did not affect waist circumference reduction. Authors conclude that calorie restricted diets could be suggested in the treatment of visceral obesity. Macronutrient composition can be adjusted to meet the patient’s individual needs.
Abstract
OBJECTIVES Many individuals with visceral obesity who previously had succeeded in reducing body weight regain and this loss-gain cycle repeats several times which is called as weight cycling. We aimed to evaluate the effect of a low calorie high protein diet (HP) compared to a low calorie standard protein diet (SP) on waist circumference of visceral obese adults with history of weight cycling. RESULTS In this open-randomized clinical trial, participants were asked to follow dietary plan with reduction in daily caloric intake ranging from 500 to 1000 kcal from usual daily amount with minimum daily amount of 1000 kcal for 8 weeks and were divided in two groups: HP group with protein as 22-30% total calorie intake; and SP group with protein as 12-20% total calorie intake. There was a statistically significant difference (P < 0.001) between waist circumference before and after the dietary intervention among both groups. Meanwhile, there was no statistically significant difference in the mean reduction of waist circumference between HP and SP groups (P = 0.073). Taken together, the protein proportion does not significantly affected waist circumference. Trial registration ClinicalTrials.gov NCT03374150, 11 December 2017.