We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multicomponent Telecare Model for Supporting Prediabetes Patients (MTELECAREP)

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: NCT01671293
Recruitment Status : Completed
First Posted : August 23, 2012
Results First Posted : June 30, 2015
Last Update Posted : June 30, 2015
Sponsor:
Collaborators:
National Fund for Research and Development in Health, Chile
Corporación Municipal de Educación, Salud y Recreación de La Florida
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief Summary:
The purpose of this study is to determine whether a multi-component remote care model (telephone-based) is effective to achieve the modification of unhealthy eating practices and increase physical activity in adults who have prediabetes and over-weight/obesity. The effectiveness of the remote care model will be determined with respect to the mentioned practices as well as anthropometric parameters (Waist circumference and Weight) and clinical parameters (Fasting Glucose, Triglycerides, Total Cholesterol) which are sensitive to changes in these habits. The counseling intervention is the core of the multi-component tele-care model, which also includes counseling-through text messages, supply of Educational material and self-monitoring equipment (pedometers and measuring tape for patients to check their waist circumference).

Condition or disease Intervention/treatment Phase
Prediabetic State Glucose Intolerance Behavioral: Multicomponent remote care model Other: Usual care Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remote Care Model for Supporting Prediabetes Patients
Study Start Date : September 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Multicomponent remote care model
A remote intervention based on counseling (telephone-based).
Behavioral: Multicomponent remote care model
A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer & waist circumference measuring tape). The phone counseling is made by health centers professionals who have been trained to apply theories on behavioral change and decision-making. Phone counseling is conducted at least once a month. Messages are sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- seek to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.

Active Comparator: Usual care
Usual care.
Other: Usual care
Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments




Primary Outcome Measures :
  1. Change From Baseline in Weight Parameter [ Time Frame: baseline and post intervention (6 -9 months after the first phone counseling session) ]
    Patient's weight wil be measured in kilograms using scales.


Secondary Outcome Measures :
  1. Change From Baseline in Self Report of Physical Activity [ Time Frame: baseline and post intervention (6 -9 months after the first phone counseling session) ]
    The level of physical activity reported by participants is measured using the Rapid Assessment Physical Activity Scale (RAPA; Tolpolski et al., 2006), in its version adapted for Chile. This instrument is made up by 9 dichotomous questions, which point to a physical activity level corresponding to the following categories: sedentary, under-active, under-active regular-light activities, under-active regular, and active, depending on the frequency and intensity of the physical activity done. The instrument adaptation process of the instrument is conducted as part of the present study.

  2. Change From Baseline in Fasting Glucose [ Time Frame: baseline and post intervention (6 -9 months after the first phone counseling session) ]

    Fasting Glucose will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:

    Method:Colorimetric - Hexokinase / Glucose 6-phosphate-DH. UV. Equipment: Siemens Dimension RXL. Normal Range: 70-100 mg/dL.


  3. Change From Baseline in Triglycerides [ Time Frame: baseline and post intervention (6 -9 months after the first phone counseling session) ]

    It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:

    Method:Colorimetric - GPO/PAP blank glycerol. Equipment: Siemens Dimension RXL. Normal Range: ≤ 150 mg/dL.


  4. Change From Baseline in Total Cholesterol [ Time Frame: baseline and post intervention (6 -9 months after the first phone counseling session) ]

    It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:

    Method: Colorimetric - CHOD/PAP.Equipment: Siemens Dimension RXL. Normal Range: ≤ 200 mg/dL


  5. Change From Baseline in Self Report of Dietary Practices [ Time Frame: baseline and post intervention (6 -9 months after the first phone counseling session) ]
    The dietary practices reported by the participants will be measured with an instrument designed with this purpose in mind as part of the present study. The instrument is constituted by 17 items aimed at measuring the frequency of healthy and unhealthy eating. It was constructed on the basis of items present in the Diabetes Self Care Activities Measure (Toobert, Hampson, & Glasgow, 2000) and of others created by the Stanford Patient Education Research Center. Some of these items were used to measure dietary practices in Chilean populations diagnosed with Diabetes Mellitus (Lange et al., 2010)

  6. Change of Baseline in Knowledge About Prediabetes [ Time Frame: baseline and post intervention (6 -9 months after the first phone counseling session) ]
    A self-report questionnaire was developed to measure patients' knowledge about prediabetes, the risk factors for its appearance, and its treatment (or management). Is is made up by 18 items in which the person must say whether the statement presented is true or false. In addition, the instrument measures the subjective perception of the risk of developing diabetes (one item).

  7. Change of Baseline in Waist Circumference [ Time Frame: baseline and post intervention (6 -9 months after the first phone counseling session) ]
    Participants' waist circumference will be measured in centimeters using a measuring tape. The circumference will be measured at the highest part of the iliac crest (The Canadian Physical Activity, Fitness and Lifestyle approach, 2010)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prediabetes diagnosis
  • 25- 34 Body Mass Index
  • cellphone

Exclusion Criteria:

  • Fasting blood glucose ≥ 126 (at the beginning of the intervention).
  • Terminal chronic diseases
  • Major cardiovascular problems (ie: angina pectoris, myocardial infarction, cerebrovascular accident)
  • Severe psychiatric pathology
  • Presence of another pathology which, for the doctor assessing the patient (at the beginning of the intervention), can be a contraindications to participate in the program.
  • be pregnant
  • To belong to private health system (called ISAPRE).

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): NCT01671293


Locations
Layout table for location information
Chile
Centro de Salud Santa Amalia
Santiago, Región Metropolitana, Chile, 8250403
Centro de Salud Familiar Villa O'Higgins
Santiago, Región Metropolitana, Chile, 8260558
Centro de Salud Familiar Fernando Maffioletti-Alvo
Santiago, Región Metropolitana, Chile, 8301588
Centro de Salud Familiar Los Quillayes
Santiago, Región Metropolitana, Chile, 8310695
Centro de Salud Familiar Los Castaños
Santiago, Región Metropolitanta, Chile, 8270041
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
National Fund for Research and Development in Health, Chile
Corporación Municipal de Educación, Salud y Recreación de La Florida
Investigators
Layout table for investigator information
Principal Investigator: Janet Carola Pérez Ewert Pontificia Universidad Catolica de Chile
Layout table for additonal information
Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01671293    
Other Study ID Numbers: FONIS SA10I20017
First Posted: August 23, 2012    Key Record Dates
Results First Posted: June 30, 2015
Last Update Posted: June 30, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia