Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Castilla-León Health Service | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: Lifestyle counseling | Active Comparator | Counseling on physical activity and Mediterranean diet. |
|
| Intervention group | Experimental | Add for three months a smartphone with an app (EVIDENT) to improve alimentation and physical activity, five cardio-health rides and feeding workshop. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group | Other | Smartphone with APP (EVIDENT) for 3 months, cardio-health rides and feeding workshop. Counseling on physical activity and Mediterranean diet. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Increase physical activity measurement by pedometer | Measurement by pedometer. | 1 year |
| HbA1c | Measurement by laboratory test sampling |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Care Research Unit - The Alamedilla Center for Health | Salamanca | 37003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30849947 | Derived | 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. | |
| 30808196 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D006266 | Health Education |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control: Lifestyle counseling | Other | Conseling on physical activity and nutrition (intervention) |
|
| 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 |
| 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. |
| 28912193 | Derived | 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. |
| D010349 |
| Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |