Habit Formation for Diabetes Self-Management

Diabete Type 2 Clinical Trial

Official title:

The Effectiveness of an Occupation-Based Habit Formation Intervention in Promoting Healthy Behaviors Among Individuals With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455242
• Other study ID #: IRB-20-185
• Status: Completed
• Phase: N/A
• Start date: January 16, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2022
• Source: Des Moines University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Des Moines University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Diabetes Self-Care	The Summary of Diabetes Self-Care Activities (SDSCA) is a self-report questionnaire of DSM (diet, exercise, blood-glucose monitoring, foot care, and smoking) for which individuals report frequency of activities during the past 7 days (Toobert et al., 2000). A global self-care behavior score (average of items 1-10) was reported in days per week the participant executed self-care activities. In addition, combined subscales were used for general diet, specific diet, exercise, and blood glucose testing using a global average of items 1-8, reported in days per week. As part of baseline phase data collection (Phase A), the Summary of Diabetes Self-Care Activities (SDSCA) was administered once weekly for 4 weeks. Following the initial evaluation, interventions (phase B) were provided to participants once per week for 10 weeks and began with administration of the SDSCA.	13 weeks
Primary	Change in Behavior Automaticity	The Self-Report Behavior Automaticity Index SRBAI is a measure of habit strength and automaticity. Individuals respond how they perform a target behavior using a 7-point scale, with 7 meaning a better outcome. The initial evaluation session closed the baseline phase (Phase A) and initiated the intervention phase (Phase B) of the study. In this initial session, individuals were guided in setting a context-specific implementation intention for habit formation of a simple occupational habit related to nutrition. These nutrition intentions were utilized to create target behaviors for the Self-Report Behavioral Automaticity Index (SRBAI), which was administered at the end of the first session. Following the initial evaluation, interventions were provided to participants once per week for 10 weeks and began with administration of the SRBAI.	10 weeks