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临床试验/NCT01963494
NCT01963494已完成不适用

Days in Motion: A Planning Intervention Study With Couples to Enhance Daily Physical Activity (DiM)

Freie Universität Berlin2 个研究点 分布在 1 个国家目标入组 346 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
346
试验地点
2
主要终点
Physical activity

研究概览

简要总结

Regular physical activity is one prominent health-protective behaviour which might increase with the help of self-regulatory strategies such as action planning.

The aim of this randomised controlled trial is to examine changes in daily moderate physical activity in couples following (a) a dyadic planning intervention, (b) an individual planning intervention or (c) a no-planning control condition. Changes in daily physical activity will be examined over a period of one year.

It is assumed that target persons from couples receiving a dyadic planning intervention will show greater increases in daily physical activity than target persons from couples receiving an individual planning intervention. For couples receiving a dyadic planning intervention or an individual planning intervention, it is hypothesized that target persons will show higher increases in daily physical activity than target persons from couples participating in the no-planning control condition.

详细描述

Regular physical activity reduces the risk of a number of grave chronic diseases, including many forms of cancer. Guidelines indicate that increasing moderate physical activity by 30 to 60 minutes on at least 5 days of the week should already be associated with such significant health benefits. However, recent epidemiologic information indicates that only about 20% of the German adult population fully meet this important health behaviour goal.

Despite this relatively moderate recommended increase in physical activity and an apparently high acceptance of goals to increase moderate daily physical activity, many people fall short of goal achievement, as the implementation and maintenance of behaviour change often fails. Therefore, aside from enhancing motivational factors, interventions promoting health-behaviour change (e.g., increase in physical activity), are now commonly extended to address volitional strategies, such as action planning. Action planning aids individuals in translating their goals into behaviour. By forming action plans, individuals link situational cues ('when' and 'where' specifications of critical situations) to behavioural responses ('what to do' or 'how to act') in an 'if-then'-format. Available findings suggest that action planning aside from its direct effects on behaviour change, including increase in physical activity, also fosters other self-regulation strategies that are effective in the implementation and maintenance of changes in health-related behaviour. Research on action planning so far mainly focuses on its benefits for the individual's self-regulation of behaviour. To date there is little evidence on the role of the close social environment in planning health-behaviour change. However, married and cohabiting individuals often try to and succeed in coregulating their partners' health behaviour, including partners' levels of physical activity. Therefore, in the proposed study, an extension of individual action planning to the level of the dyad, i.e., dyadic planning, will be examined, along with associated mechanisms fit to aid the process of increasing physical activity. Dyadic planning refers to creating together with a partner if-then plans on when, where and how the individual target person will implement a new behaviour (e.g., be more physically active). We hypothesise that dyadic planning leads to higher increases in daily physical activity when compared to individual planning or no planning.

In the proposed randomised controlled trial, we will compare changes in daily moderate physical activity in N = 346 adults (primary outcome) and their partners who receive a general motivational treatment to enhance daily physical activity and are then randomly assigned to one of three intervention conditions: (a) a dyadic planning intervention, in which target persons form action plans to increase daily physical activity together with their partners, or (b) an individual planning intervention, in which target persons form such action plans individually and partners receive a distraction task, or (c) a no-planning control condition, in which target persons do not receive instructions for action planning, but perform a distraction task together with their partners. The study will entail an experimental longitudinal design with a baseline assessment (T0), an intervention session one week following baseline (T1) and follow-up assessments at 1 week (T2), 6 (T3; primary endpoint), 19 (T4), 26 (T6), and 52 (T7) weeks following the main intervention session. A booster intervention (T5) will take place 20 weeks after the main intervention session, i.e. 1 week following T4. Objective measurement of daily physical activity will include 4 one-week (T0, T2, T3, T7) accelerometer assessments. Additionally, further objective measurements of cardiorespiratory fitness, BMI, and waist-to-hip ratios along with self-report assessments from target persons and partners will be collected. Proposed mechanisms of the total intervention effect along with covariates will be assessed mostly via self-report.

Results of this study will contribute to the still limited understanding of the interplay of individual and dyadic regulation in the increase of daily physical activity and its maintenance, both in persons targeted by the intervention and in their partners. Findings will guide further development of this economical dyadic planning intervention that can be straightforwardly implemented in clinical settings to support the initiation and maintenance of preventive behaviour in couples. Furthermore, this theoretically-derived dyadic planning intervention can easily be extended to other domains of health-behaviour change.

研究设计

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

入排标准

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

入选标准

  • Married and/or cohabiting couples who are currently in a romantic relationship and have been living together for a minimum of 6 months

排除标准

  • Being a minor (i.e., younger than 18 years)
  • Restrictions on being physically active as assessed by a risk-check form modelled after the Physical Activity Readiness Questionnaire
  • Being a competitive athlete and engaging in vigorous physical exercise for more than 3 hours per day
  • Participating in other intervention programmes targeting physical activity or weight-loss
  • Self-reported severe cardio-vascular or pulmonary disease, diseases or injury of the musculoskeletal system, degenerative neurological diseases, paraplegia
  • Pregnancy
  • A BMI below 17.5
  • Insufficient comprehension of the German language

结局指标

主要结局

Physical activity

时间窗: six weeks post intervention

Target persons' change in moderate daily physical activity (in minutes) from baseline (T0) until 6-weeks (T3) following the intervention will be assessed by an accelerometer device. At each assessment, accelerometer devices will be worn for 7 days.

次要结局

  • Cardiorespiratory fitness(one year post intervention)
  • Dyadic action planning(one year post intervention)
  • Individual action planning(one year post intervention)
  • Individual action control(one year post intervention)
  • Received partner support(one year post intervention)
  • Provided partner support(one year post intervention)
  • Received partner control(one year post intervention)
  • Provided partner control(one year post intervention)
  • Physical activity(one year post intervention)

研究者

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

Nina Knoll

Univ.-Prof. Dr. Nina Knoll

Freie Universität Berlin

研究点 (2)

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