Multicomponent Telecare Model for Supporting Prediabetes Patients - Full Text View

Purpose

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	Intervention
Prediabetic State Glucose Intolerance	Behavioral: Multicomponent remote care model Other: Usual care

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Remote Care Model for Supporting Prediabetes Patients

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Pre-diabetes

U.S. FDA Resources

Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:

Change from baseline in Weight parameter [ Time Frame: baseline and post intervention (6 -9 months after the first phone counseling session) ] [ Designated as safety issue: No ]
Patient's weight wil be measured in kilograms using scales.

Secondary Outcome Measures:

Change from Baseline in Self report of physical activity [ Time Frame: baseline and post intervention (6 -9 months after the first phone counseling session) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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)

Enrollment:	70
Study Start Date:	September 2011
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Multicomponent remote care model A remote intervention based on counseling (telephone-based) will be 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 and measuring tape to check waist circumference).	Behavioral: Multicomponent remote care model A remote intervention based on counseling (telephone-based) will be 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 and measuring tape to check waist circumference). The phone counseling is made by professionals working at health centers 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 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.	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

Arms

Assigned Interventions

Experimental: Multicomponent remote care model

A remote intervention based on counseling (telephone-based) will be 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 and measuring tape to check waist circumference).

Behavioral: Multicomponent remote care model

A remote intervention based on counseling (telephone-based) will be 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 and measuring tape to check waist circumference). The phone counseling is made by professionals working at health centers 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 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.

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	20 Years to 64 Years
Genders Eligible for Study:	Both
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671293

Locations

Chile
Centro de Salud Santa Amalia
Santiago, Región Metropolitana, Chile, 8250403
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 Villa O'Higgins
Santiago, Región Metropolitana, Chile, 8260558
Centro de Salud Familiar Los Castaños
Santiago, Región Metropolitanta, Chile, 8270041

Sponsors and Collaborators

Pontificia Universidad Catolica de Chile

Fondo Nacional de Investigación y Desarrollo en Salud

Corporación Municipal de Educación, Salud y Recreación de La Florida

Investigators

Principal Investigator:

Janet Carola Pérez Ewert

Pontificia Universidad Católica de Chile

More Information

No publications provided

Responsible Party:	Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:	NCT01671293 History of Changes
Other Study ID Numbers:	FONIS SA10I20017
Study First Received:	August 20, 2012
Last Updated:	August 20, 2012
Health Authority:	Chile: Comisión Nacional de Investigación Científica y Tecnológica

Additional relevant MeSH terms:

Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

Multicomponent Telecare Model for Supporting Prediabetes Patients (MTELECAREP)