Effectiveness of a Multifactorial Intervention to Improve Diet and Physical Activity in Diabetics From Primary Care
Condition: Healthy
Study type: Interventional

Summary: 
      This is a randomized, clinical trial aimed at diabetics between 25-70 years (with no
      cardiovascular disease) selected at urban primary care health clinics in Salamanca (Spain).
      It is aimed at assessing the effects of adding an ICT (information and communication
      technology) tool, developed for the Smartphone application and group activities of healthy
      food and cardio-health rides in support of behavioral and educational recommendations in the
      increased physical activity and adaption to the Mediterranean dietary pattern.
    

Detailed description: 
      Objective:

      The main objective of this study is to evaluate the effect of adding a multifactorial
      intervention (ICT tool for Smartphone, cardio-health rides and a standardized advice about
      eating habits) to the usual care in the increase of the physical activity, in order to reach
      the international recommendations and in the Increased adherence to the Mediterranean diet in
      type 2 diabetic patients. Secondary objectives will be to evaluate the effect of intervention
      in improving dietary patterns, cardiovascular risk factors and metabolic control.

      Design and setting:

      A randomised controlled clinical trial, with two parallel groups, aimed at assessing the
      effects of adding an ICT tool and group activities on healthy food and cardio-health rides
      (intervention), in support of behavioral and educational recommendations (control) in the
      increased physical activity and adaption to the Mediterranean dietary pattern.

      Study setting:

      Primary Care Health Area of Salamanca in the Research Unit of La Alamedilla, belonging to the
      Spanish Network for Preventive Activities and Health Promotion (redIAPP) and Salamanca
      Institute for Biomedical Research (IBSAL).

      Study population:

      200 patients with Diabetes Mellitus Type 2, aged between 25-70 years, of both sexes, who meet
      selection criteria and signed informed consent.

      Each participant will make three visits: baseline, three and twelve months post-intervention.

      Measuring the effect of the intervention:

      The validated 14-point Mediterranean Diet Adherence Screener, the International Physical
      Activity Questionnaire (IPAQ), pedometer, laboratory values including glucose and
      glycosylated hemoglobin, and quality of life questionnaire (SF -12).
    

Intervention name(s): Intervention group; Control: Lifestyle counseling
Intervention type(s): Other; Other
Intervention description(s): Smartphone with APP (EVIDENT) for 3 months, cardio-health rides and feeding workshop.
Counseling on physical activity and Mediterranean diet.; Conseling on physical activity and nutrition (intervention)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Food Habits; Health education; Physical activity; Information and Communication Technologies