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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991079
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
Castilla-León Health Service
Information provided by (Responsible Party):
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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.

Condition or disease Intervention/treatment Phase
Healthy Other: Intervention group Other: Control: Lifestyle counseling Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of a Multifactorial Intervention to Improve Diet and Physical Activity in Diabetic Patients From Primary Care: A Randomised Controlled Trial
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : March 17, 2018
Actual Study Completion Date : March 28, 2018

Resource links provided by the National Library of Medicine


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: Intervention group

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

Counseling on physical activity and Mediterranean diet.


Other: Control: Lifestyle counseling
Conseling on physical activity and nutrition (intervention)




Primary Outcome Measures :
  1. Adherence to the Mediterranean diet using the validated 14-point Mediterranean Diet Adherence Screener [ Time Frame: 1 year ]
    Principal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener.

  2. Self-reported physical activity measured by the International Physical Activity Questionary - Short Form [ Time Frame: 1 year ]
    Measured by the International Physical Activity Questionary - Short Form


Secondary Outcome Measures :
  1. Increase physical activity measurement by pedometer [ Time Frame: 1 year ]
    Measurement by pedometer.

  2. HbA1c [ Time Frame: 1 year ]
    Measurement by laboratory test sampling

  3. Fasting Plasma Glucose [ Time Frame: 1 year ]
    Measurement by laboratory test sampling

  4. Quality of life measured by SF-12 test [ Time Frame: 1 year ]
    Measurement by SF-12 test

  5. Cardiovascular risk factors measured by Framingham Risk Score [ Time Frame: 1 year ]
    Measurement by Framingham Risk Score



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991079


Locations
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Spain
Primary Care Research Unit - The Alamedilla Center for Health
Salamanca, Spain, 37003
Sponsors and Collaborators
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Castilla-León Health Service
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT02991079    
Other Study ID Numbers: GRS 1276/B/16
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud:
Food Habits
Health education
Physical activity
Information and Communication Technologies