NCT01909349

Brief Summary

Persons undergoing cardiac rehabilitation often have difficulties transferring the learned health behaviors into their daily routine which decreases their health status. Computer-based tailored interventions have been shown to be effective in increasing physical activity as well as fruit and vegetable consumption. The aim of this study is, to support people in transferring these two learned behavior changes and their antecedents into their daily life after cardiac rehabilitation in Germany, the Netherlands and China. The primary goal of the study is to analyze the effectiveness of a rehabilitation aftercare program with regard to the level of physical activity and nutrition.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
3 countries

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

July 17, 2013

Last Update Submit

April 17, 2017

Conditions

CARDIOVASCULAR DISEASESHEART DISEASES

Keywords

medical rehabilitationaftercaremultiple health behavior changedietphysical activitycomputerinternational studyETHNOPSYCHOLOGYHABITHEALTHeHealtheLearning

Outcome Measures

Primary Outcomes (1)

  • Change in dietary and physical activity behavior (self-report)

    change scores (mean, residual change) and percentage meeting the recommendations

    Baseline to 8 weeks later

Secondary Outcomes (19)

  • Body weight

    8 weeks

  • BMI

    8 weeks

  • Days of absence from work

    8 weeks

  • Quality of Life

    8 weeks

  • Quality of Life

    3 months

  • +14 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Control Group will gain access to the intervention after the intervention group has finished the program (\>8 weeks after signing up)

Intervention Group I

EXPERIMENTAL

Self-regulation support Behavior sequence: Physical activity, then fruit \& vegetable intake

Behavioral: self-regulation

Interventions

self-regulationBEHAVIORAL

Web-based support for behavior change regarding physical activity and fruit \& vegetable consumption

Intervention Group I

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People have Internet access
  • People have sufficient knowledge of the Dutch/German language, writing and reading skills
  • People have completed cardiac rehabilitation treatment or have suffered from at least one cardiac disease/event in the last 6 months
  • People received behavior lifestyle recommendations with regard to physical activity and fruit and vegetable consumption

You may not qualify if:

  • People who do not want to sign the informed consent
  • People with contraindications with regard to physical activity and fruit and vegetable intake
  • People without Internet access
  • People with insufficient abilities to use computer and Internet
  • People with poor cognitive performance/dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

China

Hong Kong, Hong Kong, China

Location

Germany

Bremen, City state Bremen, 28759, Germany

Location

The Netherlands

Maastricht, LK, 6211, Netherlands

Location

Related Publications (8)

  • Duan YP, Liang W, Guo L, Wienert J, Si GY, Lippke S. Evaluation of a Web-Based Intervention for Multiple Health Behavior Changes in Patients With Coronary Heart Disease in Home-Based Rehabilitation: Pilot Randomized Controlled Trial. J Med Internet Res. 2018 Nov 19;20(11):e12052. doi: 10.2196/12052.

    PMID: 30455167DERIVED

  • Storm V, Reinwand DA, Wienert J, Tan SL, Lippke S. The Mediating Role of Perceived Social Support Between Physical Activity Habit Strength and Depressive Symptoms in People Seeking to Decrease Their Cardiovascular Risk: Cross-Sectional Study. JMIR Ment Health. 2018 Nov 14;5(4):e11124. doi: 10.2196/11124.

    PMID: 30429112DERIVED

  • Tan SL, Storm V, Reinwand DA, Wienert J, de Vries H, Lippke S. Understanding the Positive Associations of Sleep, Physical Activity, Fruit and Vegetable Intake as Predictors of Quality of Life and Subjective Health Across Age Groups: A Theory Based, Cross-Sectional Web-Based Study. Front Psychol. 2018 Jun 18;9:977. doi: 10.3389/fpsyg.2018.00977. eCollection 2018.

    PMID: 29967588DERIVED

  • Duan YP, Wienert J, Hu C, Si GY, Lippke S. Web-Based Intervention for Physical Activity and Fruit and Vegetable Intake Among Chinese University Students: A Randomized Controlled Trial. J Med Internet Res. 2017 Apr 10;19(4):e106. doi: 10.2196/jmir.7152.

    PMID: 28396306DERIVED

  • Kuhlmann T, Reips UD, Wienert J, Lippke S. Using Visual Analogue Scales in eHealth: Non-Response Effects in a Lifestyle Intervention. J Med Internet Res. 2016 Jun 22;18(6):e126. doi: 10.2196/jmir.5271.

    PMID: 27334562DERIVED

  • Storm V, Dorenkamper J, Reinwand DA, Wienert J, De Vries H, Lippke S. Effectiveness of a Web-Based Computer-Tailored Multiple-Lifestyle Intervention for People Interested in Reducing their Cardiovascular Risk: A Randomized Controlled Trial. J Med Internet Res. 2016 Apr 11;18(4):e78. doi: 10.2196/jmir.5147.

    PMID: 27068880DERIVED

  • Reinwand DA, Crutzen R, Storm V, Wienert J, Kuhlmann T, de Vries H, Lippke S. Generating and predicting high quality action plans to facilitate physical activity and fruit and vegetable consumption: results from an experimental arm of a randomised controlled trial. BMC Public Health. 2016 Apr 12;16:317. doi: 10.1186/s12889-016-2975-3.

    PMID: 27066779DERIVED

  • Reinwand D, Kuhlmann T, Wienert J, de Vries H, Lippke S. Designing a theory- and evidence-based tailored eHealth rehabilitation aftercare program in Germany and the Netherlands: study protocol. BMC Public Health. 2013 Nov 19;13:1081. doi: 10.1186/1471-2458-13-1081.

    PMID: 24245493DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesMotor ActivityHabits

Interventions

Professional Autonomy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Sonia Lippke, Prof. Dr.

    Jacobs University Bremen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Health Psychology

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 26, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

August 1, 2016

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

NL(1)DE(1)CN(1)