The Effectiveness of an E-Intervention on Health Behavior Promotion in Chinese University Students

April 17, 2019 updated by: Yanping DUAN, Hong Kong Baptist University
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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

621

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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