Web Based Follow up Intervention in Obesity Treatment for Women

Obesity Clinical Trial

Official title:

Effects on Self-efficacy, Sustainability and Drop Out Rate Using Web Based Follow up Intervention in Obesity Treatment for Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675687
• Other study ID #: EK-12-098-VK ID by EC Vienna
• Status: Completed
• Phase: N/A
• First received: August 28, 2012
• Last updated: March 6, 2015
• Start date: August 2012
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: FEM Süd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Follow Up Support
inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training

Locations

Country	Name	City	State
Austria	FEM Süd	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
FEM Süd

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sustainability of weight loss	Sustainability will be measured in; percentage of women successfully stabilized weight (range of ± 2 kg based on Cooper et al. (2008); percentage of women keeping the scores or impair no more than 1 standard deviation in their test results ("Ad Eva Testsystem zur Diagnostik und Evaluation bei Adipositas" - Ardelt-Gattinger und Meindl, 2009; "Sportbezogene Selbstwirksamkeitserwartung" - Fuchs & Schwarzer, 1994; "Weight Efficacy Life-Style Questionnaire (WEL)" - Clark et al., 1991; "SF 36 - Fragebogen zum Gesundheitszustand" - Bullinger und Kirchberger, 1998)	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)	No
Primary	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.	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)	No
Secondary	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.	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)	No

External Links

•   Homepage of the project (German)