Effectiveness of a Multifactorial Intervention to Improve Diet and Physical Activity in Diabetics From Primary Care
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Feb 2017
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2016
CompletedFirst Posted
Study publicly available on registry
December 13, 2016
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2018
CompletedApril 24, 2018
April 1, 2018
1.1 years
December 9, 2016
April 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Increase physical activity measurement by pedometer
1 year
HbA1c
1 year
Fasting Plasma Glucose
1 year
Quality of life measured by SF-12 test
1 year
Cardiovascular risk factors measured by Framingham Risk Score
1 year
Study Arms (2)
Control: Lifestyle counseling
ACTIVE COMPARATORCounseling on physical activity and Mediterranean diet.
Intervention group
EXPERIMENTALAdd for three months a smartphone with an app (EVIDENT) to improve alimentation and physical activity, five cardio-health rides and feeding workshop.
Interventions
Smartphone with APP (EVIDENT) for 3 months, cardio-health rides and feeding workshop. Counseling on physical activity and Mediterranean diet.
Conseling on physical activity and nutrition (intervention)
Eligibility Criteria
You may qualify if:
- Subjects with Diabetes Mellitus Type 2 since 25 to 70 years.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Primary Care Research Unit - The Alamedilla Center for Health
Salamanca, 37003, Spain
Related Publications (3)
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: 30849947DERIVEDAlonso-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: 30808196DERIVEDAlonso-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: 28912193DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2016
First Posted
December 13, 2016
Study Start
February 1, 2017
Primary Completion
March 17, 2018
Study Completion
March 28, 2018
Last Updated
April 24, 2018
Record last verified: 2018-04