Online Program Assisting Lifestyle Changes (Asterix 1.0 & Obelix 2.0) (OPAL)
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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) |
- physical activity fruit & vegetable consumption [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- 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 |
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 More Information
Additional 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 May 23, 2013