Multicomponent Telecare Model for Supporting Prediabetes Patients

NCT01671293 | Completed Results

• 1 other identifier: FONIS SA10I20017
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 5

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).

Conditions

Prediabetic State; Glucose Intolerance

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Weight Parameter

  Patient's weight wil be measured in kilograms using scales.

  baseline and post intervention (6 -9 months after the first phone counseling session)

Secondary Outcomes (7)

• Change From Baseline in Self Report of Physical Activity

  baseline and post intervention (6 -9 months after the first phone counseling session)

• Change From Baseline in Fasting Glucose

  baseline and post intervention (6 -9 months after the first phone counseling session)

• Change From Baseline in Triglycerides

  baseline and post intervention (6 -9 months after the first phone counseling session)

• Change From Baseline in Total Cholesterol

  baseline and post intervention (6 -9 months after the first phone counseling session)

• Change From Baseline in Self Report of Dietary Practices

  baseline and post intervention (6 -9 months after the first phone counseling session)

Study Arms (2)

Multicomponent remote care model

EXPERIMENTAL

A remote intervention based on counseling (telephone-based).

Behavioral: Multicomponent remote care model

Usual care

ACTIVE COMPARATOR

Usual care.

Other: Usual care

Interventions

Multicomponent remote care model BEHAVIORAL

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.

Multicomponent remote care model

Usual care OTHER

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

Usual care

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Prediabetes diagnosis
• Body Mass Index
• cellphone

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• National Fund for Research and Development in Health, Chile: collaborator
• Corporación Municipal de Educación, Salud y Recreación de La Florida: collaborator

Study Sites (5)

Centro de Salud Familiar Los Castaños

Santiago, Región Metropolitanta, 8270041, Chile

Location

Centro de Salud Santa Amalia

Santiago, Santiago Metropolitan, 8250403, Chile

Location

Centro de Salud Familiar Villa O'Higgins

Santiago, Santiago Metropolitan, 8260558, Chile

Location

Centro de Salud Familiar Fernando Maffioletti-Alvo

Santiago, Santiago Metropolitan, 8301588, Chile

Location

Centro de Salud Familiar Los Quillayes

Santiago, Santiago Metropolitan, 8310695, Chile

Location

MeSH Terms

Conditions

Prediabetic State; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Results Point of Contact

• Title: J. Carola Pérez Ewert
• Organization: Universidad del Desarrollo

janetperez@udd.cl

5623279875

Study Officials

• Janet Carola Pérez Ewert

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 23, 2012
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 30, 2015
• Results First Posted: June 30, 2015

Record last verified: 2015-06

Locations

CL (5)