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Clinical Trials/NCT05455242
NCT05455242
Completed
Not Applicable

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

Des Moines University1 site in 1 country8 target enrollmentJanuary 16, 2021
ConditionsDiabete Type 2

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabete Type 2
Sponsor
Des Moines University
Enrollment
8
Locations
1
Primary Endpoint
Change in Diabetes Self-Care
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 16, 2021
End Date
December 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Diana Feldhacker

Program Director and Department Chair

Des Moines University

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.

Outcomes

Primary Outcomes

Change in Diabetes Self-Care

Time Frame: 13 weeks

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

Time Frame: 10 weeks

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.

Study Sites (1)

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