ObesityNCT01675687
Web Based Follow up Intervention in Obesity Treatment for Women
A study testing Follow Up Support in people with Obesity, run by FEM Süd at 1 site in Austria.
Trial summary
This study is designed to verify that web based follow up intervention after a classic multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise self-efficacy, improve drop out rate and advance sustainability after weight loss of obese women. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Follow Up Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2012to Sep 2014
- 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- Age 18-80
- BMI 30-40
- Internet access
- Motivation and psychological stability to stay in a long term obesity intervention
- No medical conditions prohibiting moderate physical exercise
Who cannot join
- Men
- Age under 18 years
- BMI under 30 and above 40
- No Internet access
- No motivation and psychological stability to stay in a long term obesity intervention
- Medical conditions prohibiting moderate physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects on Self-efficacy, Sustainability and Drop Out Rate Using Web Based Follow up Intervention in Obesity Treatment for Women
This study is designed to verify that web based follow up intervention after a classic multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise self-efficacy, improve drop out rate and advance sustainability after weight loss of obese women.
Research Questions and Hypotheses
- How does a web based follow up intervention change self-efficacy of women participating in an obesity intervention?
- How does a web based follow up intervention affect the drop out rate of women participating in an obesity intervention?
- How does a web based follow up intervention influence sustainability of women participating in an obesity intervention?
- Conditions
- Obesity
- Being tested
- Follow Up Support
- Keywords
- dietary habits and obesity, exercise habits and obesity, cognition and obesity
- Medical subject headings
- Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow Up SupportBehavioural
inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training
| Study group | Role | What they receive |
|---|---|---|
| Internet | Experimental | Participants of this intervention group get follow up support via Internet.
They have access to new inputs biweekly consisting of
* Thematic inputs and instructions (e.g. advice on shopping, cooking, regular exercise on daily routine, motivation and more)
* assignments promoting self-awareness and introspection
* spreadsheets promoting self-monitoring
News and updates (e.g. recipes, gymnastic classes, meetings of self support groups and more) will be available each month.
Tailored feedback of their behaviour will be given by documentation on spreadsheets. Receives: Behavioral: Follow Up Support |
| Printed Manual | Experimental | Participants of this intervention group get follow up support via a printed manual.
The manual consist of all the same inputs as are available to the Internet follow up group.
* Thematic inputs and instructions (e.g. advice on shopping, cooking, regular exercise on daily routine, motivation and more)
* assignments promoting self-awareness and introspection
* spreadsheets promoting self-monitoring
All inputs will be given at once at the beginning of the follow up intervention, only news and updates (e.g. recipes, gymnastic classes, meetings of self support groups and more) will be sent per mail each month.
There is no tailored feedback of their behaviour as the paper-pencil documentation on spreadsheets can't be monitored by the psychologists. Receives: Behavioral: Follow Up Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in nutrition- and exercise self-efficacy
Changes in nutrition- and exercise self-efficacy will be measured by scores in questionnaires for nutrition- and exercise self-efficacy (Sportbezogene Selbstwirksamkeitserwartung - Fuchs \& Schwarzer, 1994 and Weight Efficacy Life-Style Questionnaire - Clark et al. 1991). A change of more than one standard deviation will be considered significant.
Measured: Primary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
Secondary outcomes (1)
Dropout rate
The Dropout rate will be compared by the number of women available for the last meeting at the end of the follw up intervention.
Measured: Secondary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- FEM Süd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonja Rader, Mag.a, Principal investigator, FEM Süd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675687
- Sponsor's protocol ID
- EK-12-098-VK ID by EC Vienna
- Status last verified
- Mar 2015
- First submitted
- 28 Aug 2012
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Self-efficacy, Sustainability and Drop Out Rate Using Web Based Follow up Intervention in Obesity Treatment for Women
- ClinicalTrials.gov ID
- NCT01675687
- Acronym / sponsor ID
- EK-12-098-VK ID by EC Vienna
- Conditions
- Obesity
- Keywords
- dietary habits and obesity, exercise habits and obesity, cognition and obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- FEM SüdUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Aug 2012 (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.
This study is designed to verify that web based follow up intervention after a classic multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise self-efficacy, improve drop out rate and advance sustainability after weight loss of obese women.
Research Questions and Hypotheses
- How does a web based follow up intervention change self-efficacy of women participating in an obesity intervention?
- How does a web based follow up intervention affect the drop out rate of women participating in an obesity intervention?
- How does a web based follow up intervention influence sustainability of women participating in an obesity intervention?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet | Experimental | Behavioral: Follow Up SupportParticipants of this intervention group get follow up support via Internet. They have access to new inputs biweekly consisting of * Thematic inputs and instructions (e.g. advice on shopping, cooking, regular exercise on daily routine, motivation and more) * assignments promoting self-awareness and introspection * spreadsheets promoting self-monitoring News and updates (e.g. recipes, gymnastic classes, meetings of self support groups and more) will be available each month. Tailored feedback of their behaviour will be given by documentation on spreadsheets. |
| Printed Manual | Experimental | Behavioral: Follow Up SupportParticipants of this intervention group get follow up support via a printed manual. The manual consist of all the same inputs as are available to the Internet follow up group. * Thematic inputs and instructions (e.g. advice on shopping, cooking, regular exercise on daily routine, motivation and more) * assignments promoting self-awareness and introspection * spreadsheets promoting self-monitoring All inputs will be given at once at the beginning of the follow up intervention, only news and updates (e.g. recipes, gymnastic classes, meetings of self support groups and more) will be sent per mail each month. There is no tailored feedback of their behaviour as the paper-pencil documentation on spreadsheets can't be monitored by the psychologists. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women
- Age 18-80
- BMI 30-40
- Internet access
- Motivation and psychological stability to stay in a long term obesity intervention
Key exclusion criteria (6 listed)
- Men
- Age under 18 years
- BMI under 30 and above 40
- No Internet access
- No motivation and psychological stability to stay in a long term obesity intervention
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 |
|---|---|---|
| Follow Up Supportinputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training | Behavioural | Internet, Printed Manual |
Primary outcome
Changes in nutrition- and exercise self-efficacy
Time frame: Primary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
Changes in nutrition- and exercise self-efficacy will be measured by scores in questionnaires for nutrition- and exercise self-efficacy (Sportbezogene Selbstwirksamkeitserwartung - Fuchs \& Schwarzer, 1994 and Weight Efficacy Life-Style Questionnaire - Clark et al. 1991). A change of more than one standard deviation will be considered significant.
1 secondary outcome
Dropout rate
Time frame: Secondary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
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 9 Mar 2015.
- Homepage of the project (German)Link 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.
Sonja Rader, Mag.a principal investigator
FEM Süd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow Up Support in people with Obesity, run by FEM Süd at 1 site in Austria.
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 6 inclusion and 6 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 9 Mar 2015. 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 Austria. 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?
Changes in nutrition- and exercise self-efficacy (time frame: Primary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)). 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 9 Mar 2015.