- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03627949
The Effectiveness of an E-Intervention on Health Behavior Promotion in Chinese University Students
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group 1
Students in the intervention group 1 received first 4-week treatment on physical activity followed by 4-week treatment on healthy dietary behaviour.
|
The intervention will address the basic elements of the HAPA model via the use of behaviour change techniques.
In line with Abraham and Michie (2008), we use several behaviour change techniques like providing information about behavioural risk and benefit of behaviour change, prompting intention formation, prompting barrier identification, providing instructions how to perform a behaviour, prompting specific goal setting and review of behavioural goals, providing feedback on performance, prompting practice and providing follow-up prompts, prompting to plan social support and finally prompting relapse prevention, also based on strategies used by other effective computer tailoring programs.
Students attended e-health intervention session once a week with about 20 minutes each time.
|
Experimental: Intervention group 2
Students in the intervention group 2 received first 4-week treatment on healthy dietary behaviour followed by 4-week treatment on physical activity.
|
The intervention will address the basic elements of the HAPA model via the use of behaviour change techniques.
In line with Abraham and Michie (2008), we use several behaviour change techniques like providing information about behavioural risk and benefit of behaviour change, prompting intention formation, prompting barrier identification, providing instructions how to perform a behaviour, prompting specific goal setting and review of behavioural goals, providing feedback on performance, prompting practice and providing follow-up prompts, prompting to plan social support and finally prompting relapse prevention, also based on strategies used by other effective computer tailoring programs.
Students attended e-health intervention session once a week with about 20 minutes each time.
|
No Intervention: Control group
Students in the control group were not provided with any supportive treatments on physical activity or healthy dietary behaviour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of weekly amount of physical activity (PA)
Time Frame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
The level of PA will be measured through the short Chinese version of the IPAQ questionnaire (Macfarlane et al., 2007).
Participants will be asked to estimate the number of days and hours spent for vigorous, moderate and walking activities during the past week.
|
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Change of daily portions of fruit-vegetable intake (FVI)
Time Frame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
The daily portions of FVI will be measured with four items, including fruit or vegetable juice, fruit, cooked or steamed vegetables, and raw vegetables (Rafferty et al., 2002).
Respondents will be asked to count the number of portions of fruit and vegetables they consumed on average during a typical day.
|
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of stage algorithm of behaviors change
Time Frame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
For PA, participants will be asked "Please think about your typical weeks: Did you engage in PA at least 5 days per week for 30 minutes or more?"
Regarding dietary, participants will be asked "Please think about what you have typically consumed during the last weeks: Did you eat five portions of fruit and vegetables per day?" Responses are based on a rating scale with verbal anchors ("No, and I do not intend to start"; "No, but I am considering it"; "No, but I seriously intend to start"; "Yes, but only for a brief period of time"; "Yes, and for a long period of time") and are designed like a rating scale (Lippke, Ziegelmann, Schwarzer, & Velicer, 2009).
|
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Change of outcome expectancies of PA and FVI
Time Frame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Outcome expectancies will be measured by two Pros items and two Cons items for each behavior (Schwarzer, Lippke, & Luszczynska, 2011).
|
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Change of self-efficacy of PA and FVI
Time Frame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Self-efficacy will be assessed with three dimensions consisting of motivational, maintenance and recovery self-efficacies with the stem "I am certain that…" followed by 5 items for PA such as "…I can be physically active permanently at a minimum of 5 days a week for 30 minutes even if it is difficult", or followed by 5 items for FVI such as "…I can eat 5 portions of fruit and vegetable a day even if it is difficult."
(Luszczynska & Sutton, 2006).
|
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Change of risk perception of PA and FVI
Time Frame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Risk perception is adapted from Perloff and Fetzer (1986) and will be measured by 5 items.
|
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Change of intention of PA and FVI
Time Frame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Intention will be assessed by 3 items for each behavior (Lippke et al., 2009).
|
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Change of planning of PA and FVI
Time Frame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Planning will be distinguished into action planning and coping planning.
Action planning will be assessed by 3 items for each behavior.
Coping planning will be assessed by 3 items for each behavior (Schwarzer, 2008)
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From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Change of perceived social support of PA and FVI
Time Frame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
For the perceived social support, the scale will be measured with the stem as "How do you perceived your environment?"
followed by 3 items for PA such as"….People like my friends help me to stay physically active", or followed by 3 items for FVI such as "…People like my friends help me to eat healthily" (Jackson, Lippke & Gray, 2011).
|
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Change of compensatory health beliefs of PA and FVI
Time Frame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Compensatory health beliefs will be measured by 4 items (Knäuper, Rabiau, Cohen, & Patriciu, 2004).
|
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Change of perceived quality of life
Time Frame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
This indicator will be assessed by using the short version of WHO Quality of Life-BREF (WHO, 1993).
Respondents will be firstly asked about their general quality of life as "How would you rate your quality of life?", then 7 items in physical health sub-domain will be used, such as the example item "To what extent do you feel that physical pain prevents you from doing what you need to do?"
|
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
Change of body mass index (BMI)
Time Frame: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
|
The participants will be asked to report body height (in cm) and body weight (in kg) for calculate the BMI.
|
From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic information
Time Frame: At baseline
|
These items include gender, age, study year, university name, and marital status.
|
At baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FRG2/15-16/032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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