Originally published by 2 Minute Medicine® (view original article). Reused on AccessMedicine with permission.

1. In this preliminary analysis of an ongoing randomized control trial, participants assigned to an energy-reduced Mediterranean diet with counseling and physical activity showed better adherence to the Mediterranean diet than those who only received instructions to undergo a traditional Mediterranean diet.

2. Energy-reduced Mediterranean diets led to greater improvement in cardiovascular risk factors.

Evidence Rating Level: 1 (Excellent)

Study Rundown:

Obesity is commonly linked to both poorer short and long-term health conditions. Nutritional and behavioral modifications may be the most favorable solution to this key issue. However, programs to increase adherence to such a lifestyle modification are still not optimal. In this randomized control trial, participants in the intervention group that encouraged the energy-reduced Mediterranean diet, physical activity, and had behavioral support displayed significant improvement in diet adherence than those who were told to follow a Mediterranean diet. After 12 months, diet quality, energy intake, and cardiovascular risk factors were also noted to be improved in the intervention group.

The energy-reduced Mediterranean diet program was supported by individual and group counseling that likely led to better diet adherence than the control group. Though the preliminary data here suggest improvement in adherence and health with such an approach, it is unclear the magnitude of this benefit long-term and how cost-effective such an intensive approach would be.

In-Depth [randomized control trial]:

The PREDIMED-Plus trial involved 23 Spanish National Health System research centers in Spain and randomized 6874 participants into this multicenter, parallel-group, single-blind clinical trial between September 2013 and December 2016. The eligibility was determined based on age (males 55-75 years of age and females 60-75 years of age), health (no cardiovascular disease at baseline), BMI (27-40 at baseline), and a minimum of 3 criteria for Metabolic Syndrome. A traditional Mediterranean diet with patient only receiving recommendations was assigned to the control arm. An energy-reduced Mediterranean diet guided by dietitians with promotion of physical activity and behavioral support for weight loss was assigned to intervention arm. The evaluation of long-term effects of a lifestyle in the intervention group was conducted by trained dietitians by means of in-person interviews, group sessions, and monthly phone-calls. The mean [SD] age was 65.0 [4.9] years, where 52% of the participants were men (n=3406). The exclusion rate was estimated at 4%, with a total of 6583 participants completed the 12-month follow-up. 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 (difference 4.7; CI95 4.6 to 4.8). The control group was reported to be 8.6 (2.7) at baseline and 11.1 (2.8) at 12 months (difference 2.5; CI95 2.3 to 2.6; between-group difference 2.2; CI95 2.1-2.4). Overall, the intervention group reported significantly higher adherence to the diet after the course of 12 months, as compared to the control group as well as better energy intake and cardiovascular risk factor markers (p < 0.05).

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