Habit Formation for Diabetes Self-Management

NCT ID: NCT05455242

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-16
• Study Completion Date: 2021-12-30

Brief Summary

The purpose of the study is to determine the feasibility of interventions which focus on building habits as a method of improving diabetes self-management behaviors for individuals with type 2 diabetes.

Conditions

Diabete Type 2

Study Design

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

Study Groups

Habit Formation Interventions

Single subject design used for individual control (A-B design). During baseline phase (A), participants completed self-care activities ratings once per week for 4 weeks. During intervention phase (B), participants engaged in weekly sessions to address goals related to diabetes self-management and guided in habit formation. Participants engaged in intervention for 10 weeks, in accordance with habit formation recommendations by Lally et al. (2010). Each weekly session were held virtually (telephone or Zoom) and lasted 30-60 minutes, beginning with administration of the SDSCA and SRBAI. Participants were instructed in ongoing context-specific implementation intention to promote occupational participation in DSM through habit formation. This instruction included continued education and context modification recommendations. At two week intervals, additional areas of DSM were added until each were covered: blood glucose monitoring, nutrition, medication management, and physical activity.

Group Type: EXPERIMENTAL

Habit formation

Intervention Type: BEHAVIORAL

Habit formation interventions to promote context-dependent automatic behaviors to support diabetes self-management.

Interventions

Habit formation

Habit formation interventions to promote context-dependent automatic behaviors to support diabetes self-management.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 19 years old
• read and write in the English language
• have technology capability for virtual or telephone sessions
• are reachable by phone or text messaging
• have a diagnosis of T2DM
• were willing and able to participate in all study-related activities, and
• were not currently involved in other diabetes-related education and behavioral interventions.

Exclusion Criteria

• younger than 19 years old
• unable to read and write in the English language
• did not have technology capability for virtual or telephone sessions
• were not reachable by phone or text messaging
• were unwilling or unable to participate in all study-related activities, and/or
• were currently receiving or involved in other diabetes-related education and behavioral interventions.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Des Moines University

OTHER

Sponsor Role: lead

Responsible Party

Diana Feldhacker

Program Director and Department Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Creighton University

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

IRB-20-185

Identifier Type: -

Identifier Source: org_study_id