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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00986375
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : November 14, 2012
Information provided by:
Freie Universität Berlin

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Intervention Group (IG) Behavioral: Active Control Group (ACG) Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Online Program Assisting Lifestyle Changes: Adopting and Maintaining Physical Activity and Fruit & Vegetable Consumption (Asterix 1.0 & Obelix 2.0)
Study Start Date : October 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: Intervention Group (IG)
Patients in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
Behavioral: Intervention Group (IG)
patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients

Active Comparator: Active Control Group (ACG)
Patients in the ACG will get an interactive computerized standard program
Behavioral: Active Control Group (ACG)
Patients in the ACG will get an interactive computerized standard program

Primary Outcome Measures :
  1. physical activity fruit & vegetable consumption [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00986375

Freie Universitaet Berlin
Berlin, Germany, 14195
Sponsors and Collaborators
Freie Universität Berlin
Study Chair: Ralf Schwarzer, PhD Freie Universitaet Berlin

Responsible Party: Sonia Lippke, Dr.; Assistant Professor (C1), Freie Universität Berlin Identifier: NCT00986375     History of Changes
Other Study ID Numbers: FU-10-4711-001
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: February 2011

Keywords provided by Freie Universität Berlin:
Randomized Controlled Trial
evidence- and theory-based behavioral intervention
expert system
stages of change
motivational interviewing
Self Care
Expert Systems

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases