search trials
Conditions
prediabetic state, glucose intolerance
Treatments
multicomponent remote care model, usual care
Sponsor
Pontificia Universidad Catolica de Chile
Collaborator
Fondo Nacional de Investigación y Desarrollo en Salud
Start date
September 2011
End date
January 2013
Trial size
70 participants
Trial identifier
NCT01671293, FONIS SA10I20017
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).
Allocation
randomized
Intervention model
parallel assignment
Masking
open label
Primary purpose
treatment
Arm Multicomponent remote care model (Experimental) A remote intervention based on counseling (telephone-based). 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. Usual care (Active Comparator) Usual care. 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
Measure Change From Baseline in Weight Parameter time frame: baseline and post intervention (6 -9 months after the first phone counseling session)
Measure Change From Baseline in Self Report of Physical Activity time frame: baseline and post intervention (6 -9 months after the first phone counseling session) Change From Baseline in Fasting Glucose time frame: baseline and post intervention (6 -9 months after the first phone counseling session) Change From Baseline in Triglycerides time frame: baseline and post intervention (6 -9 months after the first phone counseling session) Change From Baseline in Total Cholesterol time frame: baseline and post intervention (6 -9 months after the first phone counseling session) Change From Baseline in Self Report of Dietary Practices time frame: baseline and post intervention (6 -9 months after the first phone counseling session) Change of Baseline in Knowledge About Prediabetes time frame: baseline and post intervention (6 -9 months after the first phone counseling session) Change of Baseline in Waist Circumference time frame: baseline and post intervention (6 -9 months after the first phone counseling session)
Male or female participants from 20 years up to 64 years old.
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).
Official title
Remote Care Model for Supporting Prediabetes Patients
Principal investigator
Janet Carola Pérez Ewert
Description
International data report that the population with prediabetes is approximately twice the population with Diabetes Mellitus type 2 (DM2) both in the U.S. and Latin America. Given prediabetes estimated prevalence in Chile (8 to 15%) and considering the high risk for developing DM2 that prediabetic people present, as well as the high cost associated with treating this disease and its consequences, it is essential to look for strategies to prevent and/or delay this process. People under 45 years who are overweight and have altered glucose tolerance test constitute a population who is at high risk for developing DM2 (MINSAL, 2009). It has been shown that weight loss and increase of moderate physical activity reduces by 58% the risk of developing DM2 (The Diabetes Prevention Program Research Group, 2002), however, at primary care, people who are informed of having prediabetes usually present no access to the available services to support them in the process of changing behaviors that are at the core of this condition. This study aims to design, implement and evaluate a multi-component remote care model to support people with prediabetes who are overweight or obese, at self-management of their risk behaviors of unhealthy diet and physical inactivity. This study seeks to determine whether remote care interventions aimed at overweight or obese people with prediabetes, carried out by professionals trained in motivational interviewing, behavior change theories and support health decision-making, with knowledge of prediabetes and effective interventions for coping are effective for: a) Increase participants knowledge about the risks of this condition and how to prevent them b) Provide effective support that results in an increase in daily physical activity c) Provide effective support to ensure change in their eating habits d) Achieve reduction in clinical parameters values of glucose, cholesterol and triglycerides e) Attain decrease in the anthropometric parameters body weight and waist circumference (associated with the modification of the unwanted habits). The counseling intervention is the core of the multi-component remote care model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometers and measuring tape for patients to check their waist circumference). The calls are made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. Phone counseling are conducted at least once a month. Three different types of counseling are included: (a) Welcome: aimed at exploring the factors that promote behavioral change and the goals that the patient must reach to deal with prediabetes; (b) Follow-up: aimed at accompanying the patient and/or monitoring the attainment of goals associated with the desired behavioral change, (c) Completion: for closing the intervention process, reinforcing achievements, and inviting the patient to maintain the behavioral changes made. Short Message Service (SMS) counseling is aimed at providing information and encouraging the patient to change his/her behavior in terms of nutrition and physical activity. Messages are sent weekly and are related to the topics referred to in 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. A randomized clinical study was designed, including a sample of 70 (both groups) people diagnosed with prediabetes and altered BMI, registered in 5 primary care centers in the La Florida commune, Santiago, Chile. The intervention will last 6 months. The control group will receive usual care from health centers consisting of an 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. Apart from the usual care provided in health centers, the intervention group will also receive the four components of the remote care model. Pre and post intervention measurements will be applied. At the end of the intervention (after post-measurement) control group participants will be invited to participate in an educational workshop to improve eating practices and physical activity, and will receive educational materials generated by this project, thus ensuring the principle of equity in the project's development. For the intervention group, the program is expected to lead to increased knowledge on prediabetes, increment in physical activity, improvement of clinical and anthropometric parameters as well as of eating habits, all of these are non expected results for the control group.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015. Information provided to ClinicalTrials.gov by Pontificia Universidad Catolica de Chile.
Request an invitation to join Smart Patients.
enter your email © 2018 Smart Patients, Inc., all rights reserved.
Latest updated about 19 hours ago.
