Effectiveness of a socioecological model-guided, smart device-based, self-management-oriented lifestyle intervention in community residents: protocol for a cluster-randomized controlled trial

Effectiveness of a socioecological model-guided, smart device-based, self-management-oriented lifestyle intervention in community residents: protocol for a cluster-randomized controlled trial

Healthy lifestyles are crucial for preventing chronic diseases. Nonetheless, approximately 90% of Chinese community residents regularly engage in at least one unhealthy lifestyle. Mobile smart devices-based health interventions (mHealth) that incorporate theoretical frameworks regarding behavioral c...

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Published in:BMC public health Vol. 24; no. 1; p. 32
Main Authors: Yang, Shujuan, Yu, Bin, Liao, Kai, Qiao, Xu, Fan, Yunzhe, Li, Ming, Hu, Yuekong, Chen, Jiayan, Ye, Tingting, Cai, Changwei, Ma, Chunlan, Pang, Tong, Huang, Zixing, Jia, Peng, Reinhardt, Jan D, Dou, Qingyu
Format: Journal Article
Language:English
Published: England BioMed Central Ltd 02-01-2024
BioMed Central
BMC
Subjects:
Adaptation
Analysis
Chronic diseases
Chronic illnesses
Clustering
Effectiveness
Electronic devices
Empowerment
Exercise
Health aspects
Health behavior
Health promotion
Healthy Lifestyle
Healthy lifestyles
Humans
Intervention
Intestinal microflora
Life Style
Lifestyles
Managerial skills
mHealth
Microbiota (Symbiotic organisms)
Obesity
Physical fitness
Randomized Controlled Trials as Topic
Self-Management
Smart device
Smart devices
Smartphones
Social interactions
Socioecological model
Statistical models
Study Protocol
Telemedicine
Towns
China
Self-management
mHealth
Socioecological model
Healthy lifestyles
Smart device
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Summary:Healthy lifestyles are crucial for preventing chronic diseases. Nonetheless, approximately 90% of Chinese community residents regularly engage in at least one unhealthy lifestyle. Mobile smart devices-based health interventions (mHealth) that incorporate theoretical frameworks regarding behavioral change in interaction with the environment may provide an appealing and cost-effective approach for promoting sustainable adaptations of healthier lifestyles. We designed a randomized controlled trial (RCT) to evaluate the effectiveness of a socioecological model-guided, smart device-based, and self-management-oriented lifestyles (3SLIFE) intervention, to promote healthy lifestyles among Chinese community residents. This two-arm, parallel, cluster-RCT with a 6-month intervention and 6-month follow-up period foresees to randomize a total of 20 communities/villages from 4 townships in a 1:1 ratio to either intervention or control. Within these communities, a total of at least 256 community residents will be enrolled. The experimental group will receive a multi-level intervention based on the socioecological model supplemented with a multi-dimensional empowerment approach. The control group will receive information only. The primary outcome is the reduction of modifiable unhealthy lifestyles at six months, including smoking, excess alcohol consumption, physical inactivity, unbalanced diet, and overweight/obesity. A reduction by one unhealthy behavior measured with the Healthy Lifestyle Index Score (HLIS) will be considered favorable. Secondary outcomes include reduction of specific unhealthy lifestyles at 3 months, 9 months, and 12 months, and mental health outcomes such as depression measured with PHQ-9, social outcomes such as social support measured with the modified Multidimensional Scale of Perceived Social Support, clinical outcomes such as obesity, and biomedical outcomes such as the development of gut microbiota. Data will be analyzed with mixed effects generalized linear models with family and link function determined by outcome distribution and accounting for clustering of participants in communities. This study will provide evidence concerning the effect of a mHealth intervention that incorporates a behavioral change theoretical framework on cultivating and maintaining healthy lifestyles in community residents. The study will provide insights into research on and application of similar mHealth intervention strategies to promote healthy lifestyles in community populations and settings. ChiCTR2300070575. Date of registration: April 17, 2023. https://www.chictr.org.cn/index.aspx .
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ISSN:1471-2458
1471-2458
DOI:10.1186/s12889-023-17073-w