Physical Activity, and Health-Related Quality of Life: Dyadic Research in the Context of Forming Individual, Dyadic, and Collaborative Plans (Trial 2: Patient-Partner Dyads)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Physical activity
研究概览
简要总结
THE AIMS: The project aims at investigating of the effects of three types of planning (individual planning, collaborative planning, and dyadic planning) on physical activity.The influence of three planning interventions are compared with an active control condition, including physical activity education. PARTICIPANTS: The effects of the interventions are evaluated among dyads of patient and his/her partner. The patients with physical activity-related chronic diseases (cerebrovascular diseases or diabetes) will be enrolled. A minimum of 50 dyads enrolled into the each arm of the trial (a total of 200 dyads). The interventions consist of six planning sessions.
DESIGN: The dyads are randomly assigned to one of four experimental conditions. The assessment of the main and secondary outcomes is conducted at the baseline, at 1 week after the first intervention session, at post-intervention (after six intervention sessions are completed), and at 6-, and 12-month follow-ups.
OUTCOMES: Physical activity constitutes the main outcome, whereas health-related quality of life (HRQOL), body mass index, as well as the self-regulatory strategy called the use of planning (individual, dyadic and collaborative) are secondary outcomes.
详细描述
Individual planning (also known as implementation intentions or action and coping planning) is a regulatory strategy, which refers to making plans on when, where, and how to perform an intended behavior. In dyadic planning, a target person is setting plans together with a partner on when, where, and how the target person will individually engage in behavior change. The concept of dyadic planning differs from the conceptualization of collaborative plans, where two individuals make plans on how to enact a behavior together.
The study will evaluate the effects of a short-term planning intervention. The intervention includes a total of six sessions: two face-to-face sessions with the experimenter (delivered over two weeks) and three sessions delivered over phone (over the following three weeks), one face-two-face session (delivered at one month after the third session delivered over the phone). The delivery has an individual format (the experimenter + the dyad). The total time from first to sixth session is 2 months. The setting for the interventions will include physician's offices and participant's home. The same format, schedule, delivery, and setting will be used for conducting active control group procedures.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •One person in the dyad (defined as the patient) has (1) a cardiovascular disease (any type) with recommended physical activity change or (2) diabetes (any type) with recommended physical activity change
- •The other person in the dyad (defined as the partner) is healthy or has a chronic condition without contraindications for moderate intensity physical activity
- •The partner may be a romantic partner, a next of kin, a family member, or a friend who is willing to join the study together with the patient
- •The patient and partner are in the stable relationship for at least one year or meet and spend time together regularly for at least one year
排除标准
- •Any existing diseases with contraindications for moderate intensity physical activity, confirmed by patient's primary care physician or a specialist in cardiovascular diseases/endocrinology/rehabilitation medicine providing care for the patient during the recruitment and follow-ups
- •Participants who meet the guidelines for physical activity for their respective age group and health status in terms of minutes per week, the intensity of physical activity, and the types of exercises
结局指标
主要结局
Physical activity
时间窗: Change from the baseline physical activity at 8 months
The International Physical Activity Questionnaire (IPAQ) (Craig et al., 2003)
次要结局
- The use of planning(Change from baseline use of planning at 2 months)
- Body mass index (BMI)(Change from baseline BMI at 8 months)
- Health-related quality of life (HRQOL)(Change from baseline HRQOL at 8 months)
- Physical activity(Change from baseline physical activity at 8 months)