Development and Application of a Sedentary Behavior Intervention Program Based on the Integrated Theory of Health Behavior Change for Older Adults With Coronary Heart Disease and Frailty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in Average Daily Sedentary Time
研究概览
简要总结
This study aims to evaluate the feasibility and effectiveness of a sedentary behavior intervention based on the Integrated Theory of Health Behavior Change (ITHBC) in older adults with coronary heart disease and frailty. Participants will be randomly assigned to an intervention group or a control group. The intervention is designed around the three core components of ITHBC-knowledge and beliefs, self-regulation skills and abilities, and social facilitation-to help participants reduce sedentary behavior, improve physical activity, and enhance their ability to manage health-related behaviors. The study will include a 1-month intervention period followed by a 2-month follow-up period, with a total study duration of 3 months for each participant. Changes in sedentary behavior and other health-related outcomes will be assessed throughout the study period.
详细描述
This study is designed to develop and evaluate a sedentary behavior intervention for older adults with coronary heart disease and frailty based on the Integrated Theory of Health Behavior Change (ITHBC). The intervention framework incorporates the three major components of ITHBC: knowledge and beliefs, self-regulation skills and abilities, and social facilitation.
The intervention is intended to improve participants' knowledge and beliefs regarding sedentary behavior and its health consequences, strengthen their motivation and confidence for behavior change, enhance self-regulation skills such as goal setting, self-monitoring, action planning, feedback, and behavioral adjustment, and provide appropriate professional, family, and social support. These strategies are integrated to facilitate the initiation and maintenance of sedentary behavior change.
The study consists of a 1-month structured intervention period followed by a 2-month follow-up period, resulting in a total study duration of 3 months for each participant. Participants in the intervention group will receive the ITHBC-based sedentary behavior intervention according to the study protocol, while participants in the control group will receive the comparator specified in the protocol. The effectiveness of the intervention will be evaluated by comparing changes in sedentary behavior and other prespecified health-related outcomes between the groups during the intervention and follow-up periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessors will be blinded to group allocation. Participants, investigators, and intervention providers will not be blinded because of the nature of the behavioral intervention. Outcome assessors will not participate in participant recruitment, randomization, or intervention delivery. Participants will be instructed not to disclose their group allocation to the outcome assessors during assessments.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years or older.
- •Diagnosis of stable coronary artery disease according to the Chinese Primary -Care Guideline for Stable Coronary Artery Disease (2020).
- •Canadian Cardiovascular Society (CCS) angina class I or II.
- •Fried Frailty Phenotype score of 1 or higher, including participants with pre-frailty (score 1-2) or frailty (score 3-5).
- •Total sedentary time of 6 hours or more per day.
- •The participant or the participant's primary caregiver is able to use the WeChat application.
- •Able and willing to provide informed consent and voluntarily participate in the study.
排除标准
- •Currently participating in another research study.
- •Presence of a malignant tumor.
- •Presence of a severe infectious disease.
- •Presence of a physical impairment that substantially limits limb mobility.
- •Presence of a language impairment that prevents effective communication or -completion of study assessments.
- •Presence of cognitive impairment that prevents understanding of study procedures or completion of study assessments.
研究组 & 干预措施
ITHBC-Based Sedentary Behavior Intervention
Participants in this arm will receive a 1-month sedentary behavior intervention based on the Integrated Theory of Health Behavior Change (ITHBC), in addition to usual care. The intervention incorporates strategies targeting knowledge and beliefs, self-regulation skills and abilities, and social facilitation. Participants will subsequently be followed for 2 months, resulting in a total study duration of 3 months.
干预措施: ITHBC-Based Sedentary Behavior Intervention (Behavioral)
Usual Care
Participants in this arm will receive usual care provided by the clinical team and will not receive the ITHBC-based sedentary behavior intervention. Participants will be followed for the same 3-month study period as the intervention group.
结局指标
主要结局
Change in Average Daily Sedentary Time
时间窗: Baseline, Day 8, Month 1, and Month 3
Average daily sedentary time will be assessed using the Older Adults Sedentary Behavior Questionnaire. The questionnaire assesses sedentary behavior during the previous 7 days across seven common sedentary domains, including watching television or videos, using a mobile phone or listening to music or radio, reading, socializing with family or friends, engaging in sedentary hobbies, resting or napping, and other sedentary activities. Time spent in each domain is reported in 15-minute increments from 0 minutes to 6 hours. Daily total sedentary time will be derived from the reported sedentary time across the seven domains and expressed as time spent sedentary per day. Lower values indicate less sedentary time.
次要结局
- Change From Baseline in Longest Continuous Sedentary Bout Duration(Baseline, Day 8, Month 1, and Month 3)
- Change From Baseline in Frequency of Sedentary Bouts Lasting 30 Minutes or Longer(Baseline, Day 8, Month 1, and Month 3)
- Change From Baseline in Self-Efficacy to Reduce Sedentary Behavior(Baseline, Day 8, Month 1, and Month 3)
- Change From Baseline in Fried Frailty Phenotype Score(Baseline, Month 1，Month 3)
- Change From Baseline in Health-Related Quality of Life Assessed by the SF-36(Baseline, Month 1 and Month 3)
研究者
Xie Yajie
Master's Student in Nursing
Gansu University of Chinese Medicine