Effectiveness of a Multifactorial Intervention to Improve Diet and Physical Activity in Diabetics From Primary Care

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effectiveness of a Multifactorial Intervention to Improve Diet and Physical Activity in Diabetic Patients From Primary Care: A Randomised Controlled Trial

Conditions
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Healthy

Intervention / Treatment
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* Other: Intervention group
* Other: Control: Lifestyle counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with Diabetes Mellitus Type 2 since 25 to 70 years. Exclusion Criteria: Older than 70 years are excluded, due to difficulties in the use of ICTs. History of cardiovascular events (acute myocardial infarction, stroke, etc). Diagnosis of clinically demonstrable neurological and/or neuropsychological disease. Muscular-skeletal pathology that inhibit mobility. Those with any other circumstance that the investigators consider could interfere with the study procedures.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control: Lifestyle counseling<br>Counseling on physical activity and Mediterranean diet. | Other: Control: Lifestyle counseling<br>* Conseling on physical activity and nutrition (intervention)<br>|
| Experimental: Intervention group<br>Add for three months a smartphone with an app (EVIDENT) to improve alimentation and physical activity, five cardio-health rides and feeding workshop. | Other: Intervention group<br>* Smartphone with APP (EVIDENT) for 3 months, cardio-health rides and feeding workshop. Counseling on physical activity and Mediterranean diet.<br>Other: Control: Lifestyle counseling<br>* Conseling on physical activity and nutrition (intervention)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the Mediterranean diet using the validated 14-point Mediterranean Diet Adherence Screener | Principal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener. | 1 year | 
| Self-reported physical activity measured by the International Physical Activity Questionary - Short Form | Measured by the International Physical Activity Questionary - Short Form | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase physical activity measurement by pedometer | Measurement by pedometer. | 1 year | 
| HbA1c | Measurement by laboratory test sampling | 1 year | 
| Fasting Plasma Glucose | Measurement by laboratory test sampling | 1 year | 
| Quality of life measured by SF-12 test | Measurement by SF-12 test | 1 year | 
| Cardiovascular risk factors measured by Framingham Risk Score | Measurement by Framingham Risk Score | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Habits, Health education, Physical activity, Information and Communication Technologies