Impaired HealthLIFE!NCT02502305
Liveonline Training Course to Improve Food Habits and Enhance Physical Activity in Older Adults
A study testing liveonline course in people with Impaired Health and Motivation, run by Jacobs University Bremen gGmbH at 1 site in Germany.
Trial summary
Aim of the study is to find out if the live online course is effective with regard to health promotion. Older adults receive support to initiate a health behavior (i.e., to enhance physical activity or to improve food habits). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impaired Health, Motivation
- What is being tested?
- liveonline course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Nov 2015
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- internet access at home
- proficient language skills (German)
Who cannot join
- no internet access at home
- no proficient language skills (German)
- contra-indication for physical activity or a diet rich in fruit and vegetables
Trial locations and contacts
1 site in 1 country.
Germany1 site
Jacobs University Bremen gGmbH
Bremen, Free Hanseatic City of Bremen, 28759
About this study
Aim of the study is to find out if the live online course is effective with regard to health promotion. Older adults receive support to initiate a health behavior (i.e., to enhance physical activity or to improve food habits).
Motivation, confidence and self-management strategies are optimized to make sure participants are able to integrate the physical activity or healthy diet into their daily life.
Read the detailed description
Aim of the study is to support older adults to define a personal health behavior (to enhance physical activity, to improve food habits), to check and optimize this intention regarding self-efficacy and volitional competencies, such as action and coping planning, disability management to adopt and maintain their behavior successfully.
Research questions:
- What is the pathway from health information/intention to behavioural change (motivational and volitional processes)?
- Which are the crucial social-cognitive variables in educating/coaching adults with low health literacy in daily self-management?
- Which other resources (e.g. social support) should be targeted in interventions to empower people in health behaviour change and maintenance?
- Conditions
- Impaired Health, Motivation
- Being tested
- liveonline course
- Keywords
- health literacy, attitude, motivation
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liveonline courseBehavioural
physical activity and healthy diet are targeted and should be enhanced, health literacy (HL) in older people should be improved
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | intervention group receives liveonline course training, 3 questionnaires at an interval of 6 weeks Receives: Behavioral: liveonline course |
| Control group | No intervention | control group receives 3 questionnaires at an interval of 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
health literacy
health literacy will be assessed by questions in a questionnaire
Measured: up to 4 months
Secondary outcomes (2)
physical activity
physical activity will be assessed by questions in a questionnaire
Measured: up to 4 months
healthy diet
healthy diet will be assessed by questions in a questionnaire
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired HealthStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacobs University Bremen gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Liveonline Coaching
- Responsible party
- Principal investigator, Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH
- Investigators
- Sonia Lippke, Prof. Dr., Principal investigator, Jacobs University Bremen gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502305
- Sponsor's protocol ID
- EUFP7-30583JUB
- Acronym
- LIFE!
- Status last verified
- Apr 2017
- First submitted
- 15 Jul 2015
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liveonline Training Course to Improve Food Habits and Enhance Physical Activity in Older Adults
- ClinicalTrials.gov ID
- NCT02502305
- Acronym / sponsor ID
- LIFE! / EUFP7-30583JUB
- Conditions
- Impaired Health, Motivation
- Keywords
- health literacy, attitude, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Jacobs University Bremen gGmbHUniversity, hospital or other
- Collaborators
- Liveonline Coaching
- Study start
- Feb 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Jul 2015 (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.
Aim of the study is to find out if the live online course is effective with regard to health promotion. Older adults receive support to initiate a health behavior (i.e., to enhance physical activity or to improve food habits).
Motivation, confidence and self-management strategies are optimized to make sure participants are able to integrate the physical activity or healthy diet into their daily life.
Detailed description
Aim of the study is to support older adults to define a personal health behavior (to enhance physical activity, to improve food habits), to check and optimize this intention regarding self-efficacy and volitional competencies, such as action and coping planning, disability management to adopt and maintain their behavior successfully.
Research questions:
- What is the pathway from health information/intention to behavioural change (motivational and volitional processes)?
- Which are the crucial social-cognitive variables in educating/coaching adults with low health literacy in daily self-management?
- Which other resources (e.g. social support) should be targeted in interventions to empower people in health behaviour change and maintenance?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: liveonline courseintervention group receives liveonline course training, 3 questionnaires at an interval of 6 weeks |
| Control group | No intervention | –control group receives 3 questionnaires at an interval of 6 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- internet access at home
- proficient language skills (German)
Key exclusion criteria (3 listed)
- no internet access at home
- no proficient language skills (German)
- contra-indication for physical activity or a diet rich in fruit and vegetables
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 |
|---|---|---|
| liveonline coursephysical activity and healthy diet are targeted and should be enhanced, health literacy (HL) in older people should be improved | Behavioural | Intervention group |
Primary outcome
health literacy
Time frame: up to 4 months
health literacy will be assessed by questions in a questionnaire
2 secondary outcomes
physical activity
Time frame: up to 4 months
healthy diet
Time frame: up to 4 months
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 19 Apr 2017.
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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.
Sonia Lippke, Prof. Dr. principal investigator
Jacobs University Bremen gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liveonline course in people with Impaired Health and Motivation, run by Jacobs University Bremen gGmbH 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 2 inclusion and 3 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 19 Apr 2017. 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?
health literacy (time frame: up to 4 months). 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 19 Apr 2017.