Coronary Artery Disease, Prefrailty, Sedentary Behavior
Conditions
Keywords
Integrated Theory of Health Behavior Change, Older Adults, Behavior Change, Sedentary Time, Physical Activity
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALITHBC-Based Sedentary Behavior Intervention
The intervention is a 1-month nurse-delivered sedentary behavior intervention based on the Integrated Theory of Health Behavior Change (ITHBC). It addresses three core components of ITHBC: knowledge and beliefs, self-regulation skills and abilities, and social facilitation. Intervention strategies include health education related to sedentary behavior and coronary heart disease, individualized goal setting, self-monitoring, action planning, feedback, and professional and family/social support to facilitate reduction of sedentary behavior and promote physical activity. After the 1-month intervention period, participants will receive a 2-month follow-up to support maintenance of behavior change.
Sponsors
Gansu University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
This is a single-center, prospective, two-arm, parallel-group randomized controlled trial with a 1:1 allocation ratio. Participants will be stratified according to the Fried frailty phenotype into a pre-frail stratum (score 1-2) and a frail stratum (score 3-5). Within each stratum, participants will be randomized using variable block sizes of 4 and 6.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Daily Sedentary Time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Longest Continuous Sedentary Bout Duration | Baseline, Day 8, Month 1, and Month 3 | The longest continuous sedentary bout duration will be assessed using the Older Adults Sedentary Behavior Questionnaire. Participants will report the longest uninterrupted period of sitting, reclining, or lying during the day. Responses range from 0 minutes to 6 hours in 15-minute increments. A shorter duration indicates less prolonged sedentary behavior. |
| Change From Baseline in Frequency of Sedentary Bouts Lasting 30 Minutes or Longer | Baseline, Day 8, Month 1, and Month 3 | The frequency of prolonged sedentary bouts will be assessed using the Older Adults Sedentary Behavior Questionnaire. Participants will report the number of times per day that they remain sitting, reclining, or lying continuously for 30 minutes or longer. Response options range from 0 times to 10 or more times per day. A lower frequency indicates fewer prolonged sedentary bouts. |
| Change From Baseline in Self-Efficacy to Reduce Sedentary Behavior | Baseline, Day 8, Month 1, and Month 3 | Self-efficacy for reducing sedentary behavior will be assessed using the Chinese version of the Self-Efficacy to Reduce Sedentary Behavior (SRSB) Scale. The scale contains 9 items, each rated on a 5-point scale from 1 ("not at all confident") to 5 ("very confident"). The total score ranges from 9 to 45, with higher scores indicating greater confidence in reducing sedentary behavior. |
| Change From Baseline in Fried Frailty Phenotype Score | Baseline, Month 1，Month 3 | Frailty will be assessed using the Fried Frailty Phenotype, which includes five criteria: unintentional weight loss, reduced grip strength, exhaustion, slow walking speed, and low physical activity. Each criterion contributes 1 point, resulting in a total score ranging from 0 to 5. A score of 0 indicates robust status, 1-2 indicates pre-frailty, and 3-5 indicates frailty. Higher scores indicate greater frailty. |
| Change From Baseline in Health-Related Quality of Life Assessed by the SF-36 | Baseline, Month 1 and Month 3 | Health-related quality of life will be assessed using the Chinese version of the 36-Item Short Form Health Survey (SF-36). The instrument contains 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Higher scores indicate better health-related quality of life. |
Countries
China
Contacts
CONTACTYajie Xie
PRINCIPAL_INVESTIGATORYajie Xie
Gansu University of Chinese Medicine
Outcome results
None listed