Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients

NCT ID: NCT04702477

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-01-31

Brief Summary

Examining a number of health outcomes in those with diabetes and prediabetes before and after a group-based mindfulness intervention.

Detailed Description

This is a pilot study to examine the feasibility of integrating a mindfulness-based stress reduction (MBSR) intervention in addition to an existing group-based, peer supported clinical care model (JUMP) among patients with pre-diabetes or diabetes using a mixed-method design.

Conditions

Stress; Diabetes; Pre-Diabetes; Health Behavior; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Only Arm

This is a single-arm, paired-sample pilot intervention study among participants with pre-diabetes or diabetes. Goal to integrate a MBSR intervention into a group-based, lifestyle intervention among patients with prediabetes or diabetes in the primary care setting

Group Type: EXPERIMENTAL

Mindfulness Based Stress Reduction

Intervention Type: BEHAVIORAL

Mindfulness Based Stress Reduction (MBSR) is a well-documented approach to reduce participants' stress level \[19\], with the existing group-based peer support, self-empowerment, and lifestyle counseling intervention. MBSR is a type of meditation therapy with the goal of actively cultivating conscious attention and awareness to enhance health benefits. This included 10 hours of intervention with groups of 3-5 people.

Interventions

Mindfulness Based Stress Reduction

Mindfulness Based Stress Reduction (MBSR) is a well-documented approach to reduce participants' stress level \[19\], with the existing group-based peer support, self-empowerment, and lifestyle counseling intervention. MBSR is a type of meditation therapy with the goal of actively cultivating conscious attention and awareness to enhance health benefits. This included 10 hours of intervention with groups of 3-5 people.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• English speaking
• Having a diagnosis of diabetes or prediabetes
• Participation in a previous group-based clinical care model-JUMP (as in "JUMPing into Diabetes Control")

Exclusion Criteria

• Under 18 years old
• Non-English Speaking
• not having a diagnosis of diabetes or prediabetes
• No participation in JUMP model

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Prisma Health-Upstate

OTHER

Sponsor Role: collaborator

Clemson University

OTHER

Sponsor Role: lead

Responsible Party

Heidi Zinzow

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lu Shi, PhD

Role: PRINCIPAL_INVESTIGATOR

Clemson University

Locations

Prisma Health

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

Pro00076863

Identifier Type: -

Identifier Source: org_study_id