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

Not Applicable

Completed

• Conditions: Quality of Life; Type 2 Diabetes; Depression; Behavior, Health; Stigma, Social
• Interventions: Behavioral: Kanasina Gulabi

• Registration Number: NCT06259318
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-21
• Primary Completion: 2023-10-26
• Study Completion: 2023-10-26
• Study First Submitted: 2024-01-29
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Kanasina Gulabi	-

Primary Outcome Measures

Name	Time	Method
Reach	Week 0 - 5, Week 12	The absolute number, proportion, and representativeness of individuals who are willing to participate in the quasi-experimental study for Kanasina Gulabi.
Depressive Symptoms	Week 0, Week 5, Week 12	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.
Optimism	Week 0, Week 5, Week 12	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.
Glycemic Control	Week 0, Week 12	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.
Diabetes Distress	Week 0, Week 5, Week 12	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.
Diabetes Knowledge	Week 0, Week 5, Week 12	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.
Diabetes-Related Stigma	Week 0, Week 5, Week 12	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.

Trial Locations

Locations (1)

Public Health Research Institute of India; 🇮🇳 Mysore, Karnataka, India