Multicomponent Telecare Model for Supporting Prediabetes Patients
Condition: Prediabetic State; Glucose Intolerance
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

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.
    

Intervention name(s): Multicomponent remote care model; Usual care
Intervention type(s): Behavioral; Other
Intervention description(s): 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 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment