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

This study has been completed.
Sponsor:
Information provided by:
Freie Universität Berlin
ClinicalTrials.gov Identifier:
NCT00986375
First received: September 29, 2009
Last updated: November 12, 2012
Last verified: February 2011
  Purpose

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 Intervention
Diabetes Mellitus, Type 2
Behavioral: Intervention Group (IG)
Behavioral: Active Control Group (ACG)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Freie Universität Berlin:

Primary Outcome Measures:
  • physical activity fruit & vegetable consumption [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • subjective health & well-being [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • motivation/volition [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • social-cognitive predictors of behavior (self-efficacy, action control etc.) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • intervention engagement [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 1000
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   9 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986375

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

No publications provided

Responsible Party: Sonia Lippke, Dr.; Assistant Professor (C1), Freie Universität Berlin
ClinicalTrials.gov Identifier: NCT00986375     History of Changes
Other Study ID Numbers: FU-10-4711-001, Asterix_1.0, Obelix_2.0
Study First Received: September 29, 2009
Last Updated: November 12, 2012
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on July 24, 2014