## Protocol Section
### Identification Module
**NCT ID:** NCT02991079

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

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

#### Organization Study ID Info
**ID:** GRS 1276/B/16
#### Organization
**Class:** OTHER
**Full Name:** Fundacion para la Investigacion y Formacion en Ciencias de la Salud
### Status Module
#### Completion Date
**Date:** 2018-03-28

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-04-24

**Type:** ACTUAL

**Last Update Submit Date:** 2018-04-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-03-17

**Type:** ACTUAL

#### Start Date
**Date:** 2017-02-01

**Type:** ACTUAL

**Status Verified Date:** 2018-04

#### Study First Post Date
**Date:** 2016-12-13
**Type:** ESTIMATED
**Study First Submit Date:** 2016-12-09
**Study First Submit QC Date:** 2016-12-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Castilla-León Health Service

#### Lead Sponsor

**Class:** OTHER

**Name:** Fundacion para la Investigacion y Formacion en Ciencias de la Salud

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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).

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Food Habits

- Health education

- Physical activity

- Information and Communication Technologies

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 200

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Counseling on physical activity and Mediterranean diet.

**Intervention Names:**

- Other: Control: Lifestyle counseling

**Label:** Control: Lifestyle counseling

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Other: Intervention group

- Other: Control: Lifestyle counseling

**Label:** Intervention group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention group

**Description:** Smartphone with APP (EVIDENT) for 3 months, cardio-health rides and feeding workshop.

Counseling on physical activity and Mediterranean diet.

**Name:** Intervention group

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Control: Lifestyle counseling

- Intervention group

**Description:** Conseling on physical activity and nutrition (intervention)

**Name:** Control: Lifestyle counseling

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Principal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener.

**Measure:** Adherence to the Mediterranean diet using the validated 14-point Mediterranean Diet Adherence Screener

**Time Frame:** 1 year

**Description:** Measured by the International Physical Activity Questionary - Short Form

**Measure:** Self-reported physical activity measured by the International Physical Activity Questionary - Short Form

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** Measurement by pedometer.

**Measure:** Increase physical activity measurement by pedometer

**Time Frame:** 1 year

**Description:** Measurement by laboratory test sampling

**Measure:** HbA1c

**Time Frame:** 1 year

**Description:** Measurement by laboratory test sampling

**Measure:** Fasting Plasma Glucose

**Time Frame:** 1 year

**Description:** Measurement by SF-12 test

**Measure:** Quality of life measured by SF-12 test

**Time Frame:** 1 year

**Description:** Measurement by Framingham Risk Score

**Measure:** Cardiovascular risk factors measured by Framingham Risk Score

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 70 Years

**Minimum Age:** 25 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Salamanca

**Country:** Spain

**Facility:** Primary Care Research Unit - The Alamedilla Center for Health

**Zip:** 37003

### References Module

#### References

**Citation:** 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.

**PMID:** 30849947

**Citation:** 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.

**PMID:** 30808196

**Citation:** 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.

**PMID:** 28912193

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
