- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01675687
Web Based Follow up Intervention in Obesity Treatment for Women
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?
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Vienna, Austria, 1100
- FEM Süd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Internet
Participants of this intervention group get follow up support via Internet. They have access to new inputs biweekly consisting of
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. |
inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training
|
Experimental: Printed Manual
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.
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. |
inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
The Dropout rate will be compared by the number of women available for the last meeting at the end of the follw up intervention.
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustainability of weight loss
Time Frame: Further 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)
|
Sustainability will be measured in
|
Further 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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sonja Rader, Mag.a, FEM Süd
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK-12-098-VK ID by EC Vienna
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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