Back to resultsHabit Formation for Diabetes Self-Management
Primary Purpose
Diabete Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Habit formation
Sponsored by
About this trial
This is an interventional supportive care trial for Diabete Type 2 focused on measuring Habit Formation, Occupational Therapy, Self-Management, Diabetes Type 2
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.
Sites / Locations
- Creighton University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Habit Formation Interventions
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05455242
Brief Title
Habit Formation for Diabetes Self-Management
Official Title
The Effectiveness of an Occupation-Based Habit Formation Intervention in Promoting Healthy Behaviors Among Individuals With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 16, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Des Moines University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Type 2
Keywords
Habit Formation, Occupational Therapy, Self-Management, Diabetes Type 2
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Habit Formation Interventions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Habit formation
Intervention Description
Habit formation interventions to promote context-dependent automatic behaviors to support diabetes self-management.
Primary Outcome Measure Information:
Title
Change in Diabetes Self-Care
Description
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.
Time Frame
13 weeks
Title
Change in Behavior Automaticity
Description
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.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Habit Formation for Diabetes Self-Management
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