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临床试验/NCT05455242
NCT05455242已完成不适用

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

Des Moines University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Change in Diabetes Self-Care

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Habit formation (Behavioral)

结局指标

主要结局

Change in Diabetes Self-Care

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diana Feldhacker

Program Director and Department Chair

Des Moines University

研究点 (1)

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