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

17 avril 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

621

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: E-intervention
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.
Expérimental: 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.
Comportemental: E-intervention
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.
Aucune intervention: Control group
Students in the control group were not provided with any supportive treatments on physical activity or healthy dietary behaviour.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change of weekly amount of physical activity (PA)
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change of stage algorithm of behaviors change
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Demographic information
Délai: At baseline
These items include gender, age, study year, university name, and marital status.
At baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hong Kong Baptist University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2016

Achèvement primaire (Réel)

31 décembre 2017

Achèvement de l'étude (Réel)

28 février 2018

Dates d'inscription aux études

Première soumission

1 août 2018

Première soumission répondant aux critères de contrôle qualité

8 août 2018

Première publication (Réel)

14 août 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 avril 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 avril 2019

Dernière vérification

1 avril 2019

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • FRG2/15-16/032

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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