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OpenTrials
Completed

NCT Number: NCT05455242

Habit Formation for Diabetes Self-Management

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Creighton University

Omaha, Nebraska, 68131, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Habit formation

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Des Moines University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2022
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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