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

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

Sponsors

Lead Sponsor: Freie Universität Berlin

Source 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.

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.

Overall Status Completed
Start Date October 2009
Completion Date June 2011
Primary Completion Date September 2010
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
physical activity fruit & vegetable consumption 12 weeks
Secondary Outcome
Measure Time Frame
subjective health & well-being 12 weeks
motivation/volition 12 weeks
social-cognitive predictors of behavior (self-efficacy, action control etc.) 12 weeks
intervention engagement 12 weeks
Enrollment 1000
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Intervention Group (IG)

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

Arm Group Label: Intervention Group (IG)

Intervention Type: Behavioral

Intervention Name: Active Control Group (ACG)

Description: Patients in the ACG will get an interactive computerized standard program

Arm Group Label: Active Control Group (ACG)

Eligibility

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

Gender: All

Minimum Age: 9 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Ralf Schwarzer, PhD Study Chair Freie Universitaet Berlin
Location
Facility: Freie Universitaet Berlin
Location Countries

Germany

Verification Date

February 2011

Responsible Party

Name Title: Sonia Lippke, Dr.; Assistant Professor (C1)

Organization: Freie Universität Berlin

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention Group (IG)

Type: Experimental

Description: Patients in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients

Label: Active Control Group (ACG)

Type: Active Comparator

Description: Patients in the ACG will get an interactive computerized standard program

Acronym OPAL
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov