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

November 12, 2012 updated by: Freie Universität Berlin

Online Program Assisting Lifestyle Changes: Adopting and Maintaining Physical Activity and Fruit & Vegetable Consumption (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14195
        • Freie Universitaet Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
physical activity fruit & vegetable consumption
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
subjective health & well-being
Time Frame: 12 weeks
12 weeks
motivation/volition
Time Frame: 12 weeks
12 weeks
social-cognitive predictors of behavior (self-efficacy, action control etc.)
Time Frame: 12 weeks
12 weeks
intervention engagement
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Freie Universität Berlin

Investigators

  • Study Chair: Ralf Schwarzer, PhD, Freie Universitaet Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (ESTIMATE)

September 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 12, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FU-10-4711-001
  • Asterix_1.0
  • Obelix_2.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Intervention Group (IG)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe