NCT03627949

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
621

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

August 1, 2018

Last Update Submit

April 17, 2019

Conditions

Keywords

Web-based interventionHealth behavior changeUniversity studentsHealth Action Process Approach Model

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    From baseline to 9 weeks (at the end of intervention) and 1-month follow-up

  • Change of outcome expectancies of PA and FVI

    From baseline to 9 weeks (at the end of intervention) and 1-month follow-up

  • Change of self-efficacy of PA and FVI

    From baseline to 9 weeks (at the end of intervention) and 1-month follow-up

  • Change of risk perception of PA and FVI

    From baseline to 9 weeks (at the end of intervention) and 1-month follow-up

  • Change of intention of PA and FVI

    From baseline to 9 weeks (at the end of intervention) and 1-month follow-up

  • +5 more secondary outcomes

Other Outcomes (1)

  • Demographic information

    At baseline

Study Arms (3)

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.

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.

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.

Interventions

E-interventionBEHAVIORAL

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.

Intervention group 1Intervention group 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Yanping Duan

    Hong Kong Baptist University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Dr. Duan

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 14, 2018

Study Start

June 1, 2016

Primary Completion

December 31, 2017

Study Completion

February 28, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share