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

NCT ID: NCT06259318

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-21

Study Completion Date

2023-10-26

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study is a Hybrid Type 2 Effectiveness-Implementation Trial of a pilot, 2-arm, parallel-group, quasi-randomized trial.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Kanasina Gulabi

Intervention Type BEHAVIORAL

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Public Health Research Institute of India

UNKNOWN

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eve S Puffer, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Sumedha Ariely, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Public Health Research Institute of India

Mysore, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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2023-03-11-77

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0247

Identifier Type: -

Identifier Source: org_study_id

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