Feasibility of Kanasina Gulabi, a Pilot Peer Support Intervention for Young Adults With Type 2 Diabetes in Mysore District, South India

Depression Clinical Trial

Official title:

Feasibility of Kanasina Gulabi, a Pilot Peer Support Intervention for Young Adults With Type 2 Diabetes in Mysore District, South India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06259318
• Other study ID #: 2023-0247
• Secondary ID: 2023-03-11-77
• Status: Completed
• Phase: N/A
• Start date: June 21, 2023
• Est. completion date: October 26, 2023

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate a pilot peer support intervention, entitled "Kanasina Gulabi" (Translation "My Dream Rose" in Kannada), designed to improve quality of life and diabetes management among young adults living with type 2 diabetes. The intervention, delivered by non-specialist providers - trained young adult peer navigators who are also managing type 2 diabetes - is expected to improve physical and mental health outcomes among participants. The sample includes young adults aged 18-40 with a diagnosis of type 2 diabetes in Mysore district, South India. Participants were quasi-randomly allocated to the intervention or control group. With the support of their peer navigators, intervention participants will develop action plans to improve their physical and mental health outcomes. This study plans to assess the feasibility, acceptability, and preliminary effectiveness of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• aged 18 - 40 years old

• self-reported to have type 2 diabetes

• living in Mysore district

• able to speak English or Kannada

• and able to access a cellular phone during the study period

Exclusion Criteria:

• pregnant

• living with a serious medical or psychological disorder that would impede study procedure

Related Conditions & MeSH terms

• Behavior, Health
• Depression
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Quality of Life
• Stigma, Social
• Type 2 Diabetes

Intervention

Behavioral:
• Kanasina Gulabi
Kanasina Gulabi is a theory-driven, educational-behavioral intervention designed to improve the quality of life and diabetes management among young adults living with type 2 diabetes in Mysore district, South India. In this intervention, young adults with type 2 diabetes were matched to non-specialist peer navigators -- trained young adult peers who were also managing type 2 diabetes -- and developed action plans to improve their physical and mental health outcomes. Intervention components included group education, mindfulness activities, self care activity tracking, and phone follow-ups to address knowledge gaps and misinformation about type 2 diabetes, build self-efficacy for type 2 diabetes-related self care activities, and provide emotional support for diabetes management.

Locations

Country	Name	City	State
India	Public Health Research Institute of India	Mysore	Karnataka

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Public Health Research Institute of India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach	The absolute number, proportion, and representativeness of individuals who are willing to participate in the quasi-experimental study for Kanasina Gulabi.	Week 0 - 5, Week 12
Primary	Glycemic Control	Percentage of measured hemoglobin A1c (HbA1c) that represents average blood sugar levels over the past 3 months, used to measure diabetes management and glycemic control.	Week 0, Week 12
Primary	Diabetes Knowledge	Diabetes Knowledge Questionnaire (DKQ-24). 24 self-report items to assess overall diabetes knowledge. Responses are measured as true, false, or don't know. One composite score is calculated (range: 0 - 24); higher scores reflect better diabetes knowledge.	Week 0, Week 5, Week 12
Primary	Diabetes Distress	Type 2 Diabetes Distress Assessment System (T2-DDAS). 8 self-report items to assess diabetes-related emotional distress in adults with type 2 diabetes. Responses are endorsed on a 5-point scale and refer to the past month. One composite mean score is calculated (range: 0 - 5); higher scores reflect more diabetes distress.	Week 0, Week 5, Week 12
Primary	Diabetes-Related Stigma	Type 2 Diabetes Stigma Assessment Scale (DSAS-2). 19 self-report items to assess perceived and experienced stigma for adults with type 2 diabetes. Responses are endorsed on a 5-point scale and refer to the past two weeks. One composite score is calculated (range: 19 - 95); higher scores reflect more experiences of stigma.	Week 0, Week 5, Week 12
Primary	Depressive Symptoms	Patient Health Questionnaire (PHQ-9). 9 self-report items to screen for depression and assess degree of severity. Responses are endorsed on a 4-point scale and refer to the past two weeks. One composite score is calculated (range: 0 - 27); higher scores reflect more depressive symptoms.	Week 0, Week 5, Week 12
Primary	Optimism	Revised Life Orientation Test (LOT-R). 10 self-report items to measure positive and negative expectations strongly linked to the future. Responses are endorsed on a 5-point scale. One composite score is calculated (range: 0 - 24); higher scores reflect higher dispositional optimism.	Week 0, Week 5, Week 12