DiabetesPLEASEDNCT02661581
Peer-led, Empowerment-based, Approach to Self-management Efforts in Diabetes
A study testing Peer Support in people with Diabetes, run by University of British Columbia at 1 site in Canada.
Trial summary
PLEASED is a 12-month program that aims to help South Asians with type 2 diabetes improve and sustain diabetes-related health outcomes e.g. glycemic control, quality of life...) achieved from previous short-term diabetes education program. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
To be eligible to participate as a subject in this study, individuals must
- Have type 2 diabetes,
- Be of South Asian background,
- Live in the Metro Vancouver area,
- Be at least 21 years old,
- Have transportation to attend group sessions.
To be eligible to participate as a peer leader in this study, individuals must
- Have diabetes or are a caregiver to someone who has diabetes,
- Are of South Asian background,
- Live in the Greater Vancouver area,
- Are at least 21 years old,
- Are bilingual in English and Punjabi,
- Have transportation to attend training,
- Are able and willing to commit to 6 sessions of training (5 hours each, over a 6 week period)
Exclusion criteria for both participants and peer leaders include:
- Serious health conditions
- Addictions to alcohol or drugs, which would hinder meaningful participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peer-led, Empowerment-based, Approach to Self-management Efforts in Diabetes: A Pragmatic Trial
PLEASED is a 12-month program that aims to help South Asians with type 2 diabetes improve and sustain diabetes-related health outcomes e.g. glycemic control, quality of life...) achieved from previous short-term diabetes education program. Our goal is to provide a new generation of education and support that can be ongoing, patient-driven, and flexible to the dynamic and evolving conditions of patients' "real-word" environment and life circumstances.
Read the detailed description
Diabetes self-management education: In the first three months of PLEASED, patients with type 2 diabetes will participate in 12 weekly sessions: 6 sessions will focus on diabetes education and be delivered by a health professional and 6 sessions will focus on lifestyle change and be delivered by a peer leader. Education sessions will be 2-hours long and be facilitated by nurses, dieticians, and pharmacists. Patients will learn about the diabetes disease process, lifestyle modification, healthy eating, physical activity, medications, monitoring, short- and long- complications, diabetes distress, and coping. Lifestyle change sessions will be 1-hour long and start with 30 minutes of physical activity followed by 30 minutes of goal-setting, action planning, and problem solving. Additional activities such as recipe makeovers and exchanges will also be included.
Diabetes self-management support: In the next nine months of the PLEASED program, patients will be invited to attend 32 weekly self-management support sessions (1-hour long) facilitated by a peer leader. The goal of these sessions is to help patients continue making positive lifestyle changes. Each support session will start with 30 minutes of physical activity led by the peer leader followed by a discussion where participants are invited to (1) discuss self-management challenges, (2) share thoughts and feelings about these challenges, (3) ask self-management questions, (4) engage in problem solving, and (5) set self-management goals and design behavioral experiments to achieve those goals. Patients are invited to attend as frequently as they need or as they are able to given other competing life demands. While these sessions focus on lifestyle change and emotional support, participants will be able to obtain responses to medical and clinical questions from 811 or the PLEASED hotline (hosted by dieticians, nurses, and pharmacists).
All patients enrolled in the PLEASED program will undergo three free health assessments: at the start of the program, at 3 months, and at 12 months. Health assessments will include measuring glycemic control, ApoB, blood pressure, waist circumference, weight, and body mass index. All patients will also complete a survey assessing quality of life, social support, depression, and self-efficacy.
- Conditions
- Diabetes
- Being tested
- Peer Support
- Keywords
- Diabetes, Peer Leader Support
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer SupportBehavioural
The intervention is lifestyle change. First, the peer leaders will be trained how to conduct diabetes self-management education and support sessions. During the first 3 months, all the participants will attend the diabetes self-management education sessions. The participants in the intervention arm will also receive diabetes self-management support sessions as well. In the end of the first 3 months, the intervention group participants will receive weekly support sessions for 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Peer Support | Experimental | Peer support intervention group: During the first 3 months of DSME, participants in the DSMS intervention group will be invited to attend 6 lifestyle change sessions delivered a 2-person peer leader team and conducted bi-weekly. Immediately following the 3 months of DSME, participants are invited to attend 9 months of weekly DSMS sessions (60-minutes per session) delivered by a Peer Leader. These sessions are designed to sustain the self-management gains achieved in the 3 months of DSME. Receives: Behavioral: Peer Support |
| Control | No intervention | Immediately following the 6 bi-weekly DSME sessions, participants randomized to the control group will have completed their participation in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control measured by HbA1c
To compare a peer support model for diabetes self-management support (DSMS) to usual care on sustaining improvements in glycemic control achieved from short-term diabetes self-management education (DSME).
Measured: Up to 12 months
Secondary outcomes (10)
Blood pressure (mmHg) measured by Omron BP785 monitor
Measured: Up to 12 months
ApoB (g/L) will be collected using venous puncture blood draw
Measured: Up to 12 months
Waist circumference (inch) measured by Seca 203 Circumference Measuring Tape
Measured: Up to 12 months
Body Mass Index (kg/m2)
Measured: Up to 12 months
Physical activity measured by the actical accelerometer
Measured: Up to 12 months
Diabetes-specific Social Support will be assessed using a 4-item perceived social support scale developed by Tang et al. that measures amount of support and satisfaction with support from family, friends and the health care team
Measured: Up to 12 months
Depressive Symptom Severity will be assessed with the PRIME-MD Patient Health Questionnaire (PHQ-9)
Measured: Up to 12 months
Diabetes-related distress measured by the Diabetes Distress Scale (DDS), a 17-item scale developed by Polonsky and colleagues
Measured: Up to 12 months
Height measured using a stadiometer
Measured: Up to 12 months
Weight measured on a high quality, calibrated digital scale, with the participant wearing clothes, but no shoes
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startNov 2013
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- VGH and UBC Hospital Foundation
- Responsible party
- Principal investigator, Tricia Tang, University of British Columbia
- Investigators
- Tricia Tang, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661581
- Sponsor's protocol ID
- H13-02163-A002
- Acronym
- PLEASED
- Status last verified
- Dec 2024
- First submitted
- 24 Feb 2015
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-led, Empowerment-based, Approach to Self-management Efforts in Diabetes: A Pragmatic Trial
- ClinicalTrials.gov ID
- NCT02661581
- Acronym / sponsor ID
- PLEASED / H13-02163-A002
- Conditions
- Diabetes
- Keywords
- Diabetes, Peer Leader Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- VGH and UBC Hospital Foundation
- Study start
- Nov 2013
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PLEASED is a 12-month program that aims to help South Asians with type 2 diabetes improve and sustain diabetes-related health outcomes e.g. glycemic control, quality of life...) achieved from previous short-term diabetes education program. Our goal is to provide a new generation of education and support that can be ongoing, patient-driven, and flexible to the dynamic and evolving conditions of patients' "real-word" environment and life circumstances.
Detailed description
Diabetes self-management education: In the first three months of PLEASED, patients with type 2 diabetes will participate in 12 weekly sessions: 6 sessions will focus on diabetes education and be delivered by a health professional and 6 sessions will focus on lifestyle change and be delivered by a peer leader. Education sessions will be 2-hours long and be facilitated by nurses, dieticians, and pharmacists. Patients will learn about the diabetes disease process, lifestyle modification, healthy eating, physical activity, medications, monitoring, short- and long- complications, diabetes distress, and coping. Lifestyle change sessions will be 1-hour long and start with 30 minutes of physical activity followed by 30 minutes of goal-setting, action planning, and problem solving. Additional activities such as recipe makeovers and exchanges will also be included.
Diabetes self-management support: In the next nine months of the PLEASED program, patients will be invited to attend 32 weekly self-management support sessions (1-hour long) facilitated by a peer leader. The goal of these sessions is to help patients continue making positive lifestyle changes. Each support session will start with 30 minutes of physical activity led by the peer leader followed by a discussion where participants are invited to (1) discuss self-management challenges, (2) share thoughts and feelings about these challenges, (3) ask self-management questions, (4) engage in problem solving, and (5) set self-management goals and design behavioral experiments to achieve those goals. Patients are invited to attend as frequently as they need or as they are able to given other competing life demands. While these sessions focus on lifestyle change and emotional support, participants will be able to obtain responses to medical and clinical questions from 811 or the PLEASED hotline (hosted by dieticians, nurses, and pharmacists).
All patients enrolled in the PLEASED program will undergo three free health assessments: at the start of the program, at 3 months, and at 12 months. Health assessments will include measuring glycemic control, ApoB, blood pressure, waist circumference, weight, and body mass index. All patients will also complete a survey assessing quality of life, social support, depression, and self-efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Support | Experimental | Behavioral: Peer SupportPeer support intervention group: During the first 3 months of DSME, participants in the DSMS intervention group will be invited to attend 6 lifestyle change sessions delivered a 2-person peer leader team and conducted bi-weekly. Immediately following the 3 months of DSME, participants are invited to attend 9 months of weekly DSMS sessions (60-minutes per session) delivered by a Peer Leader. These sessions are designed to sustain the self-management gains achieved in the 3 months of DSME. |
| Control | No intervention | –Immediately following the 6 bi-weekly DSME sessions, participants randomized to the control group will have completed their participation in the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Peer SupportThe intervention is lifestyle change. First, the peer leaders will be trained how to conduct diabetes self-management education and support sessions. During the first 3 months, all the participants will attend the diabetes self-management education sessions. The participants in the intervention arm will also receive diabetes self-management support sessions as well. In the end of the first 3 months, the intervention group participants will receive weekly support sessions for 9 months. | Behavioural | Peer Support |
Primary outcome
Glycemic Control measured by HbA1c
Time frame: Up to 12 months
To compare a peer support model for diabetes self-management support (DSMS) to usual care on sustaining improvements in glycemic control achieved from short-term diabetes self-management education (DSME).
10 secondary outcomes
Blood pressure (mmHg) measured by Omron BP785 monitor
Time frame: Up to 12 months
ApoB (g/L) will be collected using venous puncture blood draw
Time frame: Up to 12 months
Waist circumference (inch) measured by Seca 203 Circumference Measuring Tape
Time frame: Up to 12 months
Body Mass Index (kg/m2)
Time frame: Up to 12 months
Physical activity measured by the actical accelerometer
Time frame: Up to 12 months
Diabetes-specific Social Support will be assessed using a 4-item perceived social support scale developed by Tang et al. that measures amount of support and satisfaction with support from family, friends and the health care team
Time frame: Up to 12 months
Depressive Symptom Severity will be assessed with the PRIME-MD Patient Health Questionnaire (PHQ-9)
Time frame: Up to 12 months
Diabetes-related distress measured by the Diabetes Distress Scale (DDS), a 17-item scale developed by Polonsky and colleagues
Time frame: Up to 12 months
Height measured using a stadiometer
Time frame: Up to 12 months
Weight measured on a high quality, calibrated digital scale, with the participant wearing clothes, but no shoes
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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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.
Tricia Tang, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Support in people with Diabetes, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycemic Control measured by HbA1c (time frame: Up to 12 months). 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 5 Dec 2024.