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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Control: Lifestyle counseling; Other: Intervention group

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).

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37003
    • Primary Care Research Unit - The Alamedilla Center for Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Collaborators: Castilla-León Health Service

Publications and helpful links

General Publications

• Alonso-Dominguez R, Recio-Rodriguez JI, Patino-Alonso MC, Sanchez-Aguadero N, Garcia-Ortiz L, Gomez-Marcos MA. Acute effect of healthy walking on arterial stiffness in patients with type 2 diabetes and differences by age and sex: a pre-post intervention study. BMC Cardiovasc Disord. 2019 Mar 8;19(1):56. doi: 10.1186/s12872-019-1039-x.
• Alonso-Dominguez R, Patino-Alonso MC, Sanchez-Aguadero N, Garcia-Ortiz L, Recio-Rodriguez JI, Gomez-Marcos MA. Effect of a multifactorial intervention on the increase in physical activity in subjects with type 2 diabetes mellitus: a randomized clinical trial (EMID Study). Eur J Cardiovasc Nurs. 2019 Jun;18(5):399-409. doi: 10.1177/1474515119835048. Epub 2019 Feb 26.
• Alonso-Dominguez R, Gomez-Marcos MA, Patino-Alonso MC, Sanchez-Aguadero N, Agudo-Conde C, Castano-Sanchez C, Garcia-Ortiz L, Recio-Rodriguez JI. Effectiveness of a multifactorial intervention based on an application for smartphones, heart-healthy walks and a nutritional workshop in patients with type 2 diabetes mellitus in primary care (EMID): study protocol for a randomised controlled trial. BMJ Open. 2017 Sep 14;7(9):e016191. doi: 10.1136/bmjopen-2017-016191.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): March 17, 2018
• Study Completion (Actual): March 28, 2018

Study Registration Dates

• First Submitted: December 9, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Physical activity; Health education; Food Habits; Information and Communication Technologies
• Other Study ID Numbers: GRS 1276/B/16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No