Abstract P147: A Community-Based, Heart-Healthy Lifestyle-Promoting Program Using Hybrid Behavioral Strategies: Study Protocol of a Three-Group Randomized Controlled Trial

Circulation(2023)

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摘要
Introduction: A hybrid intervention of online and offline behavioral strategies can be more effective in promoting multiple lifestyle behaviors than online strategies alone. However, little is known about the effects of hybrid behavioral strategies on the modification of multiple heart-healthy lifestyle behaviors in cardiovascular health. The present study aims to evaluate the effects of a community-based, heart-healthy lifestyle-promoting program (i.e., HeartHELP program) using hybrid behavioral strategies on heart-healthy lifestyle outcomes for individuals at cardiovascular risk. Hypothesis: We assessed three hypotheses: 1) a mobile-app group would be more likely to increase heart-healthy behavioral outcomes than a control group 2) a hybrid group would be more likely to increase heart-healthy behavioral outcomes than the control group 3) the hybrid group would be more likely to increase heart-healthy behavioral outcomes than the mobile-app group. Methods: The present study is a three-arm, parallel group, randomized controlled trial (clinical trial No. ISRCTN83643383) with assessments carried out at baseline and after a 12-week HeartHELP program. We will recruit 75 participants, each having at least one component of metabolic syndrome, in a community-based setting. The participants will be allocated to one of the following three study arms by age- and gender-stratified block randomization: (1) a hybrid group (n = 25), (2) a mobile-app group (n = 25), or (3) a control group (n = 25). The hybrid group will receive a “HeartHELP program” with hybrid strategies: (1) mobile-app use as an online strategy and (2) motivational interviewing counselling as an offline strategy. The mobile-app group will receive the online strategy exclusively. The control group will receive a brochure that will include information on cardiovascular health. The mobile-app use involves receiving text messages, self-monitoring six heart-healthy lifestyle behaviors, and receiving feedback text messages based on behavioral outcomes obtained from self-monitoring. The motivational interviewing counselling includes customized individual and group counseling based on motivational interviewing principle. At baseline and after 12 weeks, a battery of heart-healthy behavioral outcomes will be measured. The primary outcome will comprise heart-healthy behavioral practices; the secondary outcomes will be heart-healthy knowledge, heart-healthy motivation, heart-healthy self-efficacy, and cardiometabolic biomarkers (i.e., fasting glucose, total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides). In conclusion, we expect the community-based HeartHELP program to provide significant data findings on how heart-healthy behavioral practices can be improved, along with other cardiometabolic biomarkers.
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关键词
hybrid behavioral strategies,randomized controlled trial,community-based,heart-healthy,lifestyle-promoting,three-group
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