Multicomponent Telecare Model for Supporting Prediabetes Patients (MTELECAREP)
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ClinicalTrials.gov Identifier: NCT01671293 |
Recruitment Status :
Completed
First Posted : August 23, 2012
Results First Posted : June 30, 2015
Last Update Posted : June 30, 2015
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Condition or disease | Intervention/treatment | Phase |
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Prediabetic State Glucose Intolerance | Behavioral: Multicomponent remote care model Other: Usual care | Not Applicable |

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 |
Arm | Intervention/treatment |
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Experimental: Multicomponent remote care model
A remote intervention based on counseling (telephone-based).
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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.
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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 |
- 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.
- 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.
- 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.
- 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.
- 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
- 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)
- 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).
- 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)

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Ages Eligible for Study: | 20 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

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
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 |
Principal Investigator: | Janet Carola Pérez Ewert | Pontificia Universidad Catolica de Chile |
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 |
Prediabetic State Glucose Intolerance Diabetes Mellitus Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperglycemia |