Skip to main content
OpenTrials
Completed

NCT Number: NCT00986375

Online Program Assisting Lifestyle Changes (Asterix 1.0 & Obelix 2.0)

The purpose of this study is to help Internet users to adopt and maintain a healthy lifestyle, it is imperative to increase self-management competencies to improve healthy eating and regular physical activity. Aim of this research project is to evaluate an evidence- and theory-based computerized expert system in comparison to a standard program. In addition, two different tailoring criteria are compared to each other with regard to the misclassification of study participants. Internet users will be treated psychologically and followed up over 12 weeks. The computerized expert system is expected to help users better than the standard program. Both interventions are hypothesized to improve self-management competencies over time.

Completed

Looking for future studies?

Notify Me

Key information

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Freie Universitaet Berlin

Berlin, State of Berlin, 14195, Germany

About this study

Two experimental studies are planned over a time period of 12 weeks. In the nutrition study, participants will randomly be allocated to either a waiting control group (WCG) receiving a tailored intervention after the last follow-up questionnaire, an active control group (ACG), receiving an interactive quiz on all areas of healthy nutrition or to one of two intervention groups (IGs). Intervention group 1 receives one of four computerized tailored interventions based on a standard recommendation on vegetable and fruit intake, intervention group 2 receives one of the same four tailored interventions based on another criterion.

In the physical activity study, study participants in the intervention group receive an interactive, computerized expert system (Intervention Group, IG). Individuals in the Active Control Group (ACG) get a standard program, which does not tailor treatment components to the individual needs of the patients. Internet users (N = 1000) will be recruited in in the internet via press releases, personal invitations and advertised likes at well known web-sites. Study participants will be followed up over three measurement points: One to eight weeks after T1, T2 will take place. Four to 12 weeks after T1 the T3 measurement will be conducted.

The hypotheses are: Both the IG and the ACG are expected to have a higher motivation, to adopt a healthy lifestyle, to perform more health behavior and to be less likely to relapse into previous unhealthy routines at T2 and T3 than at T1. Also, IG and ACG will be healthier as well as they will report more quality of life and rehabilitation satisfaction at T2 and T3 than at T1. In comparison to ACG, the IG is hypothesized to be more effective than the ACG regarding motivation, behavior and social-cognitive predictors of behavior. Moreover, the interventions (ACG and IG) are supposed to be equally effective for different age and sex groups, obese and non-obese individuals. In the nutrition study, the IG2 will report higher on all outcome measures than IG1.

After successful evaluation and some adoptions the intervention will be implemented as a self-help program in all eligible Internet users in the Internet.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • to be capable of exercising on their own at a minimum level and/or to consume fruits and vegetables
  • able to fill out a questionnaire (no illiteracy)
  • adequate German language ability

Exclusion criteria

  • no internet access
  • no computer with keyboard

Treatment and study plan

Intervention Group (IG)

Behavioral

patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients

Active Control Group (ACG)

Behavioral

Patients in the ACG will get an interactive computerized standard program

Primary outcomes

  1. physical activity fruit & vegetable consumption

    Time frame: 12 weeks

Secondary outcomes

  1. subjective health & well-being

    Time frame: 12 weeks

  2. motivation/volition

    Time frame: 12 weeks

  3. social-cognitive predictors of behavior (self-efficacy, action control etc.)

    Time frame: 12 weeks

  4. intervention engagement

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Freie Universität Berlin

Other

Registry information

Official study title

Online Program Assisting Lifestyle Changes: Adopting and Maintaining Physical Activity and Fruit & Vegetable Consumption (Asterix 1.0 & Obelix 2.0)

Acronym: OPAL

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Sep 30, 2009
Registry last updated
Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.