跳至主要内容
临床试验/NCT02579395
NCT02579395已完成不适用

A Couples-based Approach for Increasing Physical Activity Among Adults With Type 2 Diabetes

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年10月最近更新:
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
80
试验地点
2
主要终点
Objective Physical Activity via accelerometer

研究概览

简要总结

In a 6-week experimental design, up to 90 adult couples in which one partner has Type 2 Diabetes (T2D) will be randomly assigned to either the collaborative implementation intentions (Collaborative IIs), the Individual Implementation Intentions (Individual IIs) condition, or the control condition. As this is a pilot study, randomization for the experimental groups vs the control groups will occur at a 2:1 ratio. Thus, the experimental conditions will contain up to 36 participants and the control condition will contain up to 18 participants. Adults with T2D who are living with a romantic partner, not meeting current physical activity guidelines but able and willing to begin a new physical activity (PA) routine and their partners will be assessed at baseline, 3 weeks and 6 weeks after the experimental manipulation. Partners will report on their own investment in the patient's goal and patients will report on their own PA self-efficacy. Patient's PA will be measured through self-report, partner report and accelerometers for a week prior to each survey assessment. These specific aims are planned:

AIM 1: Determine whether collaborative IIs for patient's PA lead to a greater increase in partner investment in partners of adults with T2D than do individual IIs or control.

AIM 2: Determine whether collaborative IIs for patient's PA lead to a greater increase in patient PA self-efficacy in adults with T2D than do individual IIs or control.

AIM 3: Determine whether collaborative IIs for patient's PA lead to a greater increase in patient PA in adults with T2D than do individual IIs or control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 21 years of age
  • Able to read and understand English
  • Does not meet physical activity guidelines (< 150 minutes of moderate-vigorous exercise per week) for the last 3 months* (only required of one partner)
  • Diagnosed with Type 2 Diabetes* (only required of one partner)
  • Married or living with a romantic partner

排除标准

  • Medical or physical contraindications to participate in physical activity

研究组 & 干预措施

Without spouse/romantic partner

Experimental

干预措施: Individual implementation Intentions (Behavioral)

With spouse/romantic partner

Experimental

干预措施: Collaborative implementation Intentions (Behavioral)

Control

Other

No Intervention

干预措施: Control (Behavioral)

结局指标

主要结局

Objective Physical Activity via accelerometer

时间窗: Basline, 6 weeks

Participants will wear Actigraph Accelerometers

Self-Reported Physical Activity via IPAQ

时间窗: Baseline, 3 weeks, 6 weeks

Participants will self-report their physical activity over the past week using the International Physical Activity Questionnaire (IPAQ)

次要结局

  • Physical Activity Self-Efficacy via a self efficacy scale(Baseline, 3 weeks, 6 weeks)
  • Physical Activity Partner Investment Scale(Baseline, 3 weeks, 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

A Couples-based Approach for Increasing Physical... | 临床试验