Habit Formation for Diabetes Self-Management

NCT05455242 | Completed DMC

• 1 other identifier: IRB-20-185
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Habit Formation; Occupational Therapy; Self-Management; Diabetes Type 2

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Habit Formation Interventions

EXPERIMENTAL

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

Interventions

Habit formation BEHAVIORAL

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

Habit Formation Interventions

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Des Moines University: lead

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director and Department Chair

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 13, 2022
• Study Start: January 16, 2021
• Primary Completion: August 30, 2021
• Study Completion: December 30, 2021
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)