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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991079
• Other study ID #: GRS 1276/B/16
• Status: Completed
• Phase: N/A
• First received: December 9, 2016
• Last updated: April 23, 2018
• Start date: February 1, 2017
• Est. completion date: March 28, 2018

Study information

• Verified date: April 2018
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 28, 2018
• Est. primary completion date: March 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Intervention group
Smartphone with APP (EVIDENT) for 3 months, cardio-health rides and feeding workshop. Counseling on physical activity and Mediterranean diet.
• Control: Lifestyle counseling
Conseling on physical activity and nutrition (intervention)

Locations

Country	Name	City	State
Spain	Primary Care Research Unit - The Alamedilla Center for Health	Salamanca

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud	Castilla-León Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Increase physical activity measurement by pedometer	Measurement by pedometer.	1 year
Secondary	HbA1c	Measurement by laboratory test sampling	1 year
Secondary	Fasting Plasma Glucose	Measurement by laboratory test sampling	1 year
Secondary	Quality of life measured by SF-12 test	Measurement by SF-12 test	1 year
Secondary	Cardiovascular risk factors measured by Framingham Risk Score	Measurement by Framingham Risk Score	1 year