Health BehaviorNCT03627949
The Effectiveness of an E-Intervention on Health Behavior Promotion in Chinese University Students
A study testing E-intervention in people with Health Behavior and Physical Activity, run by Hong Kong Baptist University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Physical Activity, Healthy Diet
- What is being tested?
- E-intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 621 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- have the restriction of physical mobility
- have fruit-vegetable related diseases such as diabetes or fruit allergies.
About this study
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.
Read the 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.
- Conditions
- Health Behavior, Physical Activity, Healthy Diet
- Being tested
- E-intervention
- Keywords
- Web-based intervention, Health behavior change, University students, Health Action Process Approach Model
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1 | Experimental | Students in the intervention group 1 received first 4-week treatment on physical activity followed by 4-week treatment on healthy dietary behaviour. Receives: Behavioral: E-intervention |
| Intervention group 2 | Experimental | Students in the intervention group 2 received first 4-week treatment on healthy dietary behaviour followed by 4-week treatment on physical activity. Receives: Behavioral: E-intervention |
| Control group | No intervention | Students in the control group were not provided with any supportive treatments on physical activity or healthy dietary behaviour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of weekly amount of physical activity (PA)
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.
Measured: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of daily portions of fruit-vegetable intake (FVI)
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.
Measured: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Secondary outcomes (10)
Change of stage algorithm of behaviors change
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).
Measured: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of outcome expectancies of PA and FVI
Outcome expectancies will be measured by two Pros items and two Cons items for each behavior (Schwarzer, Lippke, \& Luszczynska, 2011).
Measured: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of self-efficacy of PA and FVI
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).
Measured: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of risk perception of PA and FVI
Risk perception is adapted from Perloff and Fetzer (1986) and will be measured by 5 items.
Measured: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of intention of PA and FVI
Intention will be assessed by 3 items for each behavior (Lippke et al., 2009).
Measured: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of planning of PA and FVI
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)
Measured: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of perceived social support of PA and FVI
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).
Measured: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of compensatory health beliefs of PA and FVI
Compensatory health beliefs will be measured by 4 items (Knäuper, Rabiau, Cohen, \& Patriciu, 2004).
Measured: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of perceived quality of life
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?"
Measured: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Change of body mass index (BMI)
The participants will be asked to report body height (in cm) and body weight (in kg) for calculate the BMI.
Measured: From baseline to 9 weeks (at the end of intervention) and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Jun 2016
- Primary completion31 Dec 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanping DUAN, Hong Kong Baptist University
- Investigators
- Yanping Duan, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627949
- Sponsor's protocol ID
- FRG2/15-16/032
- Status last verified
- Apr 2019
- First submitted
- 1 Aug 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36069840Duan 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.
PubMed 35080497Liang 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.
PubMed 31409381
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an E-Intervention on Health Behavior Promotion in Chinese University Students
- ClinicalTrials.gov ID
- NCT03627949
- Acronym / sponsor ID
- FRG2/15-16/032
- Conditions
- Health Behavior, Physical Activity, Healthy Diet
- Keywords
- Web-based intervention, Health behavior change, University students, Health Action Process Approach Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Experimental | Behavioral: E-interventionStudents in the intervention group 1 received first 4-week treatment on physical activity followed by 4-week treatment on healthy dietary behaviour. |
| Intervention group 2 | Experimental | Behavioral: E-interventionStudents in the intervention group 2 received first 4-week treatment on healthy dietary behaviour followed by 4-week treatment on physical activity. |
| Control group | No intervention | –Students in the control group were not provided with any supportive treatments on physical activity or healthy dietary behaviour. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- have the restriction of physical mobility
- have fruit-vegetable related diseases such as diabetes or fruit allergies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-interventionThe 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. | Behavioural | Intervention group 1, Intervention group 2 |
Primary outcome
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.
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.
10 secondary outcomes
Change of stage algorithm of behaviors change
Time frame: 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
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
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
Change of intention of PA and FVI
Time frame: 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
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
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
Change of perceived quality of life
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 36069840Liang 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.
- Derived from this study: PubMed 35080497Duan 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.
- Derived from this study: PubMed 31409381Liang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanping Duan principal investigator
Hong Kong Baptist University
Questions about this trial
What is this clinical trial studying?
A study testing E-intervention in people with Health Behavior and Physical Activity, run by Hong Kong Baptist University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03627949, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.