Clinical trial NCT03627949: The Effectiveness of an E-Intervention on Health Behavior Promotion in Chinese University Students
Official title: The Effectiveness of an E-Intervention on Health Behavior Promotion in Chinese University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Physical Activity
Healthy Diet
Keywords: Web-based intervention
Health behavior change
University students
Health Action Process Approach Model
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 621
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Through the internet and mobile phone SMS technology, and by using the Health Action Process Approach model as a theoretical backdrop, this 8-week theory-based intervention study aimed at developing a healthy lifestyle by supporting physical activity (PA) and a healthy dietary for Chinese university students. The investigators would examine whether the two intervention groups improve the participants' motivation for PA and healthy diets in comparison to the control group; whether, with the help of an intervention program, students are able to increase the PA levels and healthy diet consumption, and whether there are different effects between the two intervention programs.

Detailed description: For the main study, the sample size was estimated by using G\*Power 3.1 software with MANOVA approach (repeated measure). For achieving small effect size of 0.15 (Lippke, Fleig, Wiedemann, \& Schwarzer, 2015), with a power (1-β) of 0.8 and alpha of 0.05, the total sample size was 306. Assuming a drop-out rate of approximately 30%, a total of 399 participants were required for the study evaluation.

The effects of the intervention were evaluated by performing several analyses of MANOVA and MANCOVA measured at three points in time (8-week apart pre-post measures, and four weeks follow-up; T1-T3).In addition, moderated multiple mediation analysis was performed (Independent variable: intervention; Moderators: stage; Dependent variable: behavioural and social-cognitive outcomes). Baseline characteristics of participants who dropped out were compared with participants who finished the intervention to examine whether drop out is at random or determined by specific characteristics.

Eligibility criteria: Inclusion Criteria:

* not professional athletes; not vegetarians
* no contraindication with respect to the physical activity or fruit and vegetable consumption.
* access to the Internet and a mobile phone.

Exclusion Criteria:

* have the restriction of physical mobility
* have fruit-vegetable related diseases such as diabetes or fruit allergies.

Primary outcomes:
measure: Change of weekly amount of physical activity (PA)
timeFrame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
measure: Change of daily portions of fruit-vegetable intake (FVI)
timeFrame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Secondary outcomes:
measure: Change of stage algorithm of behaviors change
timeFrame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
measure: Change of outcome expectancies of PA and FVI
timeFrame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
measure: Change of self-efficacy of PA and FVI
timeFrame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
measure: Change of risk perception of PA and FVI
timeFrame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
measure: Change of intention of PA and FVI
timeFrame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
measure: Change of planning of PA and FVI
timeFrame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
measure: Change of perceived social support of PA and FVI
timeFrame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
measure: Change of compensatory health beliefs of PA and FVI
timeFrame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
measure: Change of perceived quality of life
timeFrame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
measure: Change of body mass index (BMI)
timeFrame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Other outcomes:
measure: Demographic information
timeFrame: At baseline
Locations:
Study officials:
affiliation: Hong Kong Baptist University
name: Yanping Duan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liang W, Duan Y, Wang Y, Lippke S, Shang B, Lin Z, Wulff H, Baker JS. Psychosocial Mediators of Web-Based Interventions for Promoting a Healthy Lifestyle Among Chinese College Students: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2022 Sep 7;24(9):e37563. doi: 10.2196/37563.
citation: Duan Y, Liang W, Wang Y, Lippke S, Lin Z, Shang B, Baker JS. The Effectiveness of Sequentially Delivered Web-Based Interventions on Promoting Physical Activity and Fruit-Vegetable Consumption Among Chinese College Students: Mixed Methods Study. J Med Internet Res. 2022 Jan 26;24(1):e30566. doi: 10.2196/30566.
citation: Liang W, Duan YP, Shang BR, Wang YP, Hu C, Lippke S. A web-based lifestyle intervention program for Chinese college students: study protocol and baseline characteristics of a randomized placebo-controlled trial. BMC Public Health. 2019 Aug 13;19(1):1097. doi: 10.1186/s12889-019-7438-1.