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

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Status: Completed

Conditions: Healthy

Treatments: Other: Intervention group; Other: Control: Lifestyle counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02991079

GRS 1276/B/16

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Control: Lifestyle counseling

Active Comparator group

Description:

Counseling on physical activity and Mediterranean diet.

Treatment:

Other: Control: Lifestyle counseling

Intervention group

Experimental group

Description:

Add for three months a smartphone with an app (EVIDENT) to improve alimentation and physical activity, five cardio-health rides and feeding workshop.

Treatment:

Other: Intervention group

Other: Control: Lifestyle counseling