Prediabetic StateMTELECAREPNCT01671293
Multicomponent Telecare Model for Supporting Prediabetes Patients
A study testing Multicomponent remote care model in people with Prediabetic State and Glucose Intolerance, run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Prediabetic State, Glucose Intolerance
- What is being tested?
- Multicomponent remote care model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesChile
- Study dates
- Sep 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Prediabetes diagnosis
- 25- 34 Body Mass Index
- cellphone
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Chile5 sites
Centro de Salud Familiar Los Castaños
Santiago, Región Metropolitanta, 8270041
Centro de Salud Santa Amalia
Santiago, Santiago Metropolitan, 8250403
Centro de Salud Familiar Villa O'Higgins
Santiago, Santiago Metropolitan, 8260558
Centro de Salud Familiar Fernando Maffioletti-Alvo
Santiago, Santiago Metropolitan, 8301588
Centro de Salud Familiar Los Quillayes
Santiago, Santiago Metropolitan, 8310695
About this study
Official title: Remote Care Model for Supporting Prediabetes Patients
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).
Read the 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.
- Conditions
- Prediabetic State, Glucose Intolerance
- Being tested
- Multicomponent remote care model, Usual care
- Medical subject headings
- Prediabetic State, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent remote care modelBehavioural
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 careOther
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
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent remote care model | Experimental | A remote intervention based on counseling (telephone-based). Receives: Behavioral: Multicomponent remote care model |
| Usual care | Active comparator | Usual care. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Weight Parameter
Patient's weight wil be measured in kilograms using scales.
Measured: 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
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.
Measured: baseline and post intervention (6 -9 months after the first phone counseling session)
Change From Baseline in Fasting Glucose
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.
Measured: baseline and post intervention (6 -9 months after the first phone counseling session)
Change From Baseline in Triglycerides
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.
Measured: baseline and post intervention (6 -9 months after the first phone counseling session)
Change From Baseline in Total Cholesterol
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
Measured: baseline and post intervention (6 -9 months after the first phone counseling session)
Change From Baseline in Self Report of Dietary Practices
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)
Measured: baseline and post intervention (6 -9 months after the first phone counseling session)
Change of Baseline in Knowledge About Prediabetes
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).
Measured: baseline and post intervention (6 -9 months after the first phone counseling session)
Change of Baseline in Waist Circumference
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)
Measured: baseline and post intervention (6 -9 months after the first phone counseling session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- National Fund for Research and Development in Health, Chile, Corporación Municipal de Educación, Salud y Recreación de La Florida
- Responsible party
- Sponsor
- Investigators
- Janet Carola Pérez Ewert, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671293
- Sponsor's protocol ID
- FONIS SA10I20017
- Acronym
- MTELECAREP
- Status last verified
- Jun 2015
- First submitted
- 20 Aug 2012
- Last updated
- 30 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Care Model for Supporting Prediabetes Patients
- ClinicalTrials.gov ID
- NCT01671293
- Acronym / sponsor ID
- MTELECAREP / FONIS SA10I20017
- Conditions
- Prediabetic State, Glucose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- National Fund for Research and Development in Health, Chile, Corporación Municipal de Educación, Salud y Recreación de La Florida
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Aug 2012 (estimated)
- Results
- Posted 30 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent remote care model | Experimental | Behavioral: Multicomponent remote care modelA remote intervention based on counseling (telephone-based). |
| Usual care | Active comparator | Other: Usual careUsual care. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Prediabetes diagnosis
- 25- 34 Body Mass Index
- cellphone
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent remote care modelA 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. | Behavioural | Multicomponent remote care model |
| Usual careUsual 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 |
Primary outcome
Change From Baseline in Weight Parameter
Time frame: baseline and post intervention (6 -9 months after the first phone counseling session)
Patient's weight wil be measured in kilograms using scales.
7 secondary outcomes
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Carola Pérez Ewert principal investigator
Pontificia Universidad Catolica de Chile
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent remote care model in people with Prediabetic State and Glucose Intolerance, run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Weight Parameter (time frame: baseline and post intervention (6 -9 months after the first phone counseling session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.