Clinical trial NCT01671293: Multicomponent Telecare Model for Supporting Prediabetes Patients
Official title: Remote Care Model for Supporting Prediabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Glucose Intolerance
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: National Fund for Research and Development in Health, Chile
name: Corporación Municipal de Educación, Salud y Recreación de La Florida
First posted: 2012-08-23
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: Change From Baseline in Weight Parameter
timeFrame: baseline and post intervention (6 -9 months after the first phone counseling session)
Secondary outcomes:
measure: Change From Baseline in Self Report of Physical Activity
timeFrame: baseline and post intervention (6 -9 months after the first phone counseling session)
measure: Change From Baseline in Fasting Glucose
timeFrame: baseline and post intervention (6 -9 months after the first phone counseling session)
measure: Change From Baseline in Triglycerides
timeFrame: baseline and post intervention (6 -9 months after the first phone counseling session)
measure: Change From Baseline in Total Cholesterol
timeFrame: baseline and post intervention (6 -9 months after the first phone counseling session)
measure: Change From Baseline in Self Report of Dietary Practices
timeFrame: baseline and post intervention (6 -9 months after the first phone counseling session)
measure: Change of Baseline in Knowledge About Prediabetes
timeFrame: baseline and post intervention (6 -9 months after the first phone counseling session)
measure: Change of Baseline in Waist Circumference
timeFrame: baseline and post intervention (6 -9 months after the first phone counseling session)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Centro de Salud Santa Amalia
state: Región Metropolitana
city: Santiago
country: Chile
facility: Centro de Salud Familiar Villa O'Higgins
state: Región Metropolitana
city: Santiago
country: Chile
facility: Centro de Salud Familiar Fernando Maffioletti-Alvo
state: Región Metropolitana
city: Santiago
country: Chile
facility: Centro de Salud Familiar Los Quillayes
state: Región Metropolitana
city: Santiago
country: Chile
facility: Centro de Salud Familiar Los Castaños
state: Región Metropolitanta
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Janet Carola Pérez Ewert
role: PRINCIPAL_INVESTIGATOR
References: