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Completed

NCT Number: NCT06259318

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

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.

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Key information

Conditions

Type 2 Diabetes Behavior Behavior, Health Behavioral Symptoms Depression Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Quality of Life Social Behavior Social Stigma Stigma, Social

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Health Research Institute of India

Mysore, Karnataka, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kanasina Gulabi

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.

Primary outcomes

  1. Reach

    Time frame: 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.

  2. Glycemic Control

    Time frame: 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.

  3. Diabetes Knowledge

    Time frame: 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.

  4. Diabetes Distress

    Time frame: 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.

  5. Diabetes-Related Stigma

    Time frame: 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.

  6. Depressive Symptoms

    Time frame: 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.

  7. Optimism

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Public Health Research Institute of India

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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