Peer-led, Empowerment-based, Approach to Self-management Efforts in Diabetes

NCT02661581 | Completed

• 1 other identifier: H13-02163-A002
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes

Keywords

Diabetes; Peer Leader Support

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 12 months

Secondary Outcomes (10)

• Blood pressure (mmHg) measured by Omron BP785 monitor

  Up to 12 months

• ApoB (g/L) will be collected using venous puncture blood draw

  Up to 12 months

• Waist circumference (inch) measured by Seca 203 Circumference Measuring Tape

  Up to 12 months

• Body Mass Index (kg/m2)

  Up to 12 months

• Physical activity measured by the actical accelerometer

  Up to 12 months

Study Arms (2)

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.

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.

Interventions

Peer Support BEHAVIORAL

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.

Peer Support

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Serious health conditions
• Addictions to alcohol or drugs, which would hinder meaningful participation in the study.

Sponsors & Collaborators

• University of British Columbia: lead
• VGH and UBC Hospital Foundation: collaborator

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tricia Tang, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: January 22, 2016
• Study Start: November 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

CA (1)