Comparison of an Energy-Reduced Mediterranean Diet and Physical Activity Versus an Ad Libitum Mediterranean Diet in the Prevention of Type 2 Diabetes : A Secondary Analysis of a Randomized Controlled Trial
Abstract
BACKGROUND
Limited research has been done to evaluate the combined effect of energy reduction, Mediterranean diet (MedDiet), and physical activity on type 2 diabetes incidence.
OBJECTIVE
To evaluate whether an energy-reduced MedDiet (erMedDiet) plus physical activity reduces diabetes incidence compared with a standard MedDiet.
DESIGN
Prespecified secondary outcome analysis in the PREDIMED (Prevención con Dieta Mediterránea)-Plus randomized, single-blinded, controlled trial. (ISRCTN Registry: ISRCTN89898870).
SETTING
23 centers across Spain.
PARTICIPANTS
4746 adults aged 55 to 75 years with metabolic syndrome and overweight or obesity, without prior cardiovascular disease or diabetes.
INTERVENTION
Participants were randomly assigned 1:1 to an intervention group receiving an erMedDiet (planned reduction of 600 kcal per day), increased physical activity, and behavioral strategies for reducing weight, or a control group receiving ad libitum MedDiet advice.
MEASUREMENTS
Diabetes incidence was based on the American Diabetes Association criteria. Anthropometric measurements were obtained annually. Cox regression models were used to assess the intervention effect.
RESULTS
The 6-year absolute risk was 12.0% (95% CI, 11.9% to 12.1%) in the control group (349 cases) and 9.5% (CI, 9.4% to 9.5%) in the intervention group (280 cases). Over a median 6-year follow-up, diabetes incidence was 31% (CI, 18% to 41%) relatively lower in the intervention group compared with the control group, with…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 4,746 participants or records.
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