Habit Formation for Diabetes Self-Management

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

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.

Study Overview

• Status: Completed
• Conditions: Diabete Type 2
• Intervention / Treatment: Behavioral: Habit formation

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Creighton University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Des Moines University

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2021
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Occupational Therapy; Self-Management; Diabetes Type 2; Habit Formation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB-20-185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No