Physical Activity, and Health-Related Quality of Life: Dyadic Research in the Context of Forming Individual, Dyadic, and Collaborative Plans (Trial 1: Parent-Child Dyads)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 496
- 试验地点
- 1
- 主要终点
- Physical activity
研究概览
简要总结
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 parent-child (aged 10-14) dyads, with 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 schools (school nurse office) or/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
- 10 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children (age 10-14) and one healthy parents (any gender) or legal guardians
- •Child or parent/legal guardian with chronic conditions but without contraindications for moderate intensity physical activity
排除标准
- •Children younger than 10 years old
- •Parents who declared plans for changing residence during the following year (e.g., due to moving to another region of the country)
- •No parental consent at the baseline
- •No child consent at the baseline
- •Existing diseases with contraindications for moderate intensity physical activity
研究组 & 干预措施
Individual Planning
Participants are filling in the planning forms, referring to their individual physical activity. Both members of the dyad form their own, interdependent plans.
The following behavior change techniques (BCT) are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning.
干预措施: Education (Behavioral)
Individual Planning
Participants are filling in the planning forms, referring to their individual physical activity. Both members of the dyad form their own, interdependent plans.
The following behavior change techniques (BCT) are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning.
干预措施: Individual Planning (Behavioral)
Dyadic Planning
Participants are filling in the planning forms jointly. Planning refers to physical activity of only one person in the dyad, the child. The parent is actively participating in forming plans by the child.
The following BCT are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning.
干预措施: Dyadic Planning (Behavioral)
Dyadic Planning
Participants are filling in the planning forms jointly. Planning refers to physical activity of only one person in the dyad, the child. The parent is actively participating in forming plans by the child.
The following BCT are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning.
干预措施: Education (Behavioral)
Collaborative Planning
Participants are filling in the planning forms jointly. Planning refers to physical activity of both persons in the dyad (child and parent). Physical activity may be performed jointly by both persons in the dyad.
The following BCT are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning.
干预措施: Collaborative Planning (Behavioral)
Collaborative Planning
Participants are filling in the planning forms jointly. Planning refers to physical activity of both persons in the dyad (child and parent). Physical activity may be performed jointly by both persons in the dyad.
The following BCT are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning.
干预措施: Education (Behavioral)
Education
The education group received extended physical activity and healthy nutrition education program. The education includes: (1) the guidelines for physical activity and healthy nutrition, tailored to age and health status of the participant, (2) the examples of exercises and their metabolic equivalent; (3) information about healthy body mass and body composition.
干预措施: Education (Behavioral)
结局指标
主要结局
Physical activity
时间窗: Change from the baseline physical activity at 8 months
Accelerometry: ActiGraph (the model: wGT3X-B)
次要结局
- Health-related quality of life (HRQOL)(Change from baseline HRQOL at 8 months)
- 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 (HRQOOL)(Change from baseline HRQOL at 8 months)
- Sedentary behavior(Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up)
- Physical activity behavior(Baseline (before the intervention) to 1 week after the first face-to face intervention session); Baseline to 6-month follow-up)