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临床试验/NCT02990039
NCT02990039已完成不适用

A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time

University Medicine Greifswald0 个研究点目标入组 176 人开始时间: 2015年2月1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
发起方
入组人数
176
主要终点
Adherence: Drop-out rates in control and intervention group

研究概览

简要总结

The purpose of this study was (i) to develop a brief counseling letter intervention aiming to reduce sedentary time and to increase physical activity during leisure time among adults aged 42 to 64 years and (ii) to provide information on the feasibility.

详细描述

The study aimed to assess the feasibility of a brief counseling letter intervention to increase physical activity and to reduce sedentary time in leisure time.

Following the Intervention Mapping Protocol we developed the counseling letter intervention. The intervention is based on the Health Action Process Approach, comprising 3 tailored letters based on separate assessments, delivered over 6 month.

All participants consented (i) to participate in an examination at the university hospital including standardized measurements of blood pressure, waist and hip circumference, body height and weight as well as blood sample taking, (ii) to fill in a paper-pencil questionnaire, and (iii) to wear an accelerometer for 7 days at baseline and at 12-month follow-up.

A general population sample of cardiovascular healthy adults was randomly allocated to a control and an intervention group. At 5 time points (baseline, 3-month, 6-month, 7-month, and 12-month follow-up) participants of both study groups completed standardized questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
42 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age between 42 and 65 years
  • •resident in a pre-defined zip-code area

排除标准

  • •cardiovascular event (myocardial infarction, stroke) or vascular intervention
  • •self-reported body-mass-index over 35 kg/m²

研究组 & 干预措施

Counseling letter (intervention group)

Experimental

Participants of the intervention group received a brief counseling letter intervention aiming to reduce sedentary time and to increase physical activity. The intervention comprised up to three tailored letters based on separate questionnaires.

干预措施: Counseling letter (Behavioral)

No counseling letter (control group)

No Intervention

Participants of the control group did not received the brief counseling letter intervention.

结局指标

主要结局

Adherence: Drop-out rates in control and intervention group

时间窗: up to 12 month

Measures: Analyses of drop-out rates (%) in control and intervention group

次要结局

  • Feasibility: Comprehensibility on intervention material via paper-pencil-assessment(12 month)
  • physical activity by self-report(Change from Baseline Physical Activity at 12 months)
  • sedentary time by self-report(Change from Baseline Sedentary Time at 12 months)
  • sedentary time by accelerometry(Change from Baseline Sedentary Time at 12 months)
  • physical activity by accelerometry(Change from Baseline Physical Activity at 12 months)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

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