Diabetes Mellitus, Type 2OPALNCT00986375
Online Program Assisting Lifestyle Changes (Asterix 1.0 & Obelix 2.0)
A study testing Intervention Group (IG) in people with Diabetes Mellitus, Type 2, run by Freie Universität Berlin at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Intervention Group (IG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- no internet access
- no computer with keyboard
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Intervention Group (IG), Active Control Group (ACG)
- Keywords
- Randomized Controlled Trial, evidence- and theory-based behavioral intervention, expert system, stages of change, motivational interviewing, tailoring, Self Care, Rehabilitation, Expert Systems, Behavior, Motivation
- Medical subject headings
- Diabetes Mellitus, Type 2, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group (IG)Behavioural
patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
Active Control Group (ACG)Behavioural
Patients in the ACG will get an interactive computerized standard program
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (IG) | Experimental | Patients in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients Receives: Behavioral: Intervention Group (IG) |
| Active Control Group (ACG) | Active comparator | Patients in the ACG will get an interactive computerized standard program Receives: Behavioral: Active Control Group (ACG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity fruit & vegetable consumption
Measured: 12 weeks
Secondary outcomes (4)
subjective health & well-being
Measured: 12 weeks
motivation/volition
Measured: 12 weeks
social-cognitive predictors of behavior (self-efficacy, action control etc.)
Measured: 12 weeks
intervention engagement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freie Universität Berlin
- Sponsor type
- University, hospital or other
- Investigators
- Ralf Schwarzer, PhD, Study chair, Freie Universitaet Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986375
- Sponsor's protocol ID
- FU-10-4711-001
- Other IDs
- Asterix_1.0, Obelix_2.0
- Acronym
- OPAL
- Status last verified
- Feb 2011
- First submitted
- 29 Sep 2009
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Program Assisting Lifestyle Changes: Adopting and Maintaining Physical Activity and Fruit & Vegetable Consumption (Asterix 1.0 & Obelix 2.0)
- ClinicalTrials.gov ID
- NCT00986375
- Acronym / sponsor ID
- OPAL / FU-10-4711-001
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Randomized Controlled Trial, evidence- and theory-based behavioral intervention, expert system, stages of change, motivational interviewing, tailoring, Self Care, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Freie Universität BerlinUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | Behavioral: 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 |
| Active Control Group (ACG) | Active comparator | Behavioral: Active Control Group (ACG)Patients in the ACG will get an interactive computerized standard program |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- no internet access
- no computer with keyboard
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Group (IG)patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients | Behavioural | Intervention Group (IG) |
| Active Control Group (ACG)Patients in the ACG will get an interactive computerized standard program | Behavioural | Active Control Group (ACG) |
Primary outcome
physical activity fruit & vegetable consumption
Time frame: 12 weeks
4 secondary outcomes
subjective health & well-being
Time frame: 12 weeks
motivation/volition
Time frame: 12 weeks
social-cognitive predictors of behavior (self-efficacy, action control etc.)
Time frame: 12 weeks
intervention engagement
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
- web-page with interventions and questionnaires re fruit \& vegetable consumptionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Schwarzer, PhD study chair
Freie Universitaet Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group (IG) in people with Diabetes Mellitus, Type 2, run by Freie Universität Berlin at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical activity fruit & vegetable consumption (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012; AzTrials last refreshed its copy on 30 Oct 2026.