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临床试验/NCT05235360
NCT05235360已完成不适用

Factorial Trial to Test Unique and Combined Effects of Guided Thinking Tasks to Optimize a Physical Activity Intervention Among Underactive Adults

Southern Methodist University2 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2022年2月14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
184
试验地点
2
主要终点
Change in Weekly Physical Activity Minutes Across 6 Weeks (accelerometer-assessed)

研究概览

简要总结

The objective of this study is to optimize a novel, audio-recorded physical activity intervention that is scalable. Using principles of the Multiphase Optimization Strategy (MOST) framework, a full factorial study will test the unique and combined effects of different intervention components to identify which combination of components is optimal for increasing physical activity and mechanisms by which the components are or are not effective. This information will inform decisions about an optimal intervention package that is effective, efficient, and minimizes participant burden.

详细描述

Eligible participants who provide informed consent will be enrolled in a 6-week study. At the baseline session, participants will be randomized to listen to a brief audio-recording of different guided thinking tasks. The audio-recordings are based on combinations of four different intervention components that will be tested in a 2 (positive affect imagery vs. neutral) x 2 (episodic future thinking vs. recent thinking) x 2 (action planning: yes, no) x 2 (dose: high vs. low) factorial trial. Participants will also complete a 30-minute brisk walking session on a treadmill. Participants will return for weekly visits in which they again listen to their assigned audio-recording and complete a 30-minute brisk walking session.

研究设计

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

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults ages 18-64
  • Not currently meeting physical activity guidelines (<150 minutes/week of self-reported moderate-to-vigorous physical activity)
  • Capable of providing informed consent
  • Access to a smartphone with active data plan
  • Willing to attend all study visits and comply with the protocol
  • Conversant in English

排除标准

  • BMI > 40
  • orthopedic problems that would limit physical activity
  • self-reported coronary artery disease, stroke, COPD, chronic bronchitis, emphysema, diabetes

研究组 & 干预措施

Condition 6

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose

干预措施: Positive affect imagery (Behavioral)

Condition 6

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose

干预措施: Action planning (Behavioral)

Condition 6

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose

干预措施: Recent thinking (Behavioral)

Condition 6

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose

干预措施: Low dose (Behavioral)

Condition 1

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose

干预措施: Episodic future thinking (Behavioral)

Condition 1

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose

干预措施: Positive affect imagery (Behavioral)

Condition 1

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose

干预措施: Action planning (Behavioral)

Condition 1

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose

干预措施: High dose (Behavioral)

Condition 2

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose

干预措施: Episodic future thinking (Behavioral)

Condition 2

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose

干预措施: Positive affect imagery (Behavioral)

Condition 2

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose

干预措施: Action planning (Behavioral)

Condition 2

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose

干预措施: Low dose (Behavioral)

Condition 3

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) High intervention dose

干预措施: Episodic future thinking (Behavioral)

Condition 3

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) High intervention dose

干预措施: Positive affect imagery (Behavioral)

Condition 3

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) High intervention dose

干预措施: High dose (Behavioral)

Condition 4

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) Low intervention dose

干预措施: Episodic future thinking (Behavioral)

Condition 4

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) Low intervention dose

干预措施: Positive affect imagery (Behavioral)

Condition 4

Experimental

1) Episodic future thinking; 2) Positive affect imagery; 3) Low intervention dose

干预措施: Low dose (Behavioral)

Condition 5

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose

干预措施: Positive affect imagery (Behavioral)

Condition 5

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose

干预措施: Action planning (Behavioral)

Condition 5

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose

干预措施: High dose (Behavioral)

Condition 5

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose

干预措施: Recent thinking (Behavioral)

Condition 7

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) High intervention dose

干预措施: Positive affect imagery (Behavioral)

Condition 7

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) High intervention dose

干预措施: High dose (Behavioral)

Condition 7

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) High intervention dose

干预措施: Recent thinking (Behavioral)

Condition 8

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) Low intervention dose

干预措施: Positive affect imagery (Behavioral)

Condition 8

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) Low intervention dose

干预措施: Recent thinking (Behavioral)

Condition 8

Experimental

1) Recent thinking; 2) Positive affect imagery; 3) Low intervention dose

干预措施: Low dose (Behavioral)

Condition 9

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose

干预措施: Episodic future thinking (Behavioral)

Condition 9

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose

干预措施: Action planning (Behavioral)

Condition 9

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose

干预措施: High dose (Behavioral)

Condition 9

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose

干预措施: Neutral imagery (Behavioral)

Condition 10

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose

干预措施: Episodic future thinking (Behavioral)

Condition 10

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose

干预措施: Action planning (Behavioral)

Condition 10

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose

干预措施: Neutral imagery (Behavioral)

Condition 10

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose

干预措施: Low dose (Behavioral)

Condition 11

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) High intervention dose

干预措施: Episodic future thinking (Behavioral)

Condition 11

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) High intervention dose

干预措施: High dose (Behavioral)

Condition 11

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) High intervention dose

干预措施: Neutral imagery (Behavioral)

Condition 12

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) Low intervention dose

干预措施: Episodic future thinking (Behavioral)

Condition 12

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) Low intervention dose

干预措施: Neutral imagery (Behavioral)

Condition 12

Experimental

1) Episodic future thinking; 2) Neutral imagery; 3) Low intervention dose

干预措施: Low dose (Behavioral)

Condition 13

Experimental

1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose

干预措施: Action planning (Behavioral)

Condition 13

Experimental

1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose

干预措施: High dose (Behavioral)

Condition 13

Experimental

1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose

干预措施: Recent thinking (Behavioral)

Condition 13

Experimental

1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose

干预措施: Neutral imagery (Behavioral)

Condition 14

Experimental

1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose

干预措施: Action planning (Behavioral)

Condition 14

Experimental

1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose

干预措施: Recent thinking (Behavioral)

Condition 14

Experimental

1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose

干预措施: Neutral imagery (Behavioral)

Condition 14

Experimental

1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose

干预措施: Low dose (Behavioral)

Condition 15

Experimental

1) Recent thinking; 2) Neutral imagery; 3) High intervention dose

干预措施: High dose (Behavioral)

Condition 15

Experimental

1) Recent thinking; 2) Neutral imagery; 3) High intervention dose

干预措施: Recent thinking (Behavioral)

Condition 15

Experimental

1) Recent thinking; 2) Neutral imagery; 3) High intervention dose

干预措施: Neutral imagery (Behavioral)

Condition 16

Experimental

1) Recent thinking; 2) Neutral imagery; 3) Low intervention dose

干预措施: Recent thinking (Behavioral)

Condition 16

Experimental

1) Recent thinking; 2) Neutral imagery; 3) Low intervention dose

干预措施: Neutral imagery (Behavioral)

Condition 16

Experimental

1) Recent thinking; 2) Neutral imagery; 3) Low intervention dose

干预措施: Low dose (Behavioral)

结局指标

主要结局

Change in Weekly Physical Activity Minutes Across 6 Weeks (accelerometer-assessed)

时间窗: Assessed weekly at Weeks 1-6

Amount of weekly moderate-to-vigorous (MVPA) minutes (i.e., minutes of MPVA weighted by intensity) will be determined from accelerometers (ActiGraph wGT3X-BT) worn for one-week periods for six consecutive weeks.

次要结局

  • Change in Weekly Physical Activity Minutes Across 6 Weeks (self-reported)(Assessed weekly at baseline and at Weeks 1-6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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