Web Based Follow up Intervention in Obesity Treatment for Women

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Follow Up Support

About this trial

This is an interventional treatment trial for Obesity focused on measuring dietary habits and obesity, exercise habits and obesity, cognition and obesity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

FEM Süd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Internet

Printed Manual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01675687

First Posted

August 28, 2012

Last Updated

March 6, 2015

Sponsor

FEM Süd

1. Study Identification

Unique Protocol Identification Number

NCT01675687

Brief Title

Web Based Follow up Intervention in Obesity Treatment for Women

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FEM Süd

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

dietary habits and obesity, exercise habits and obesity, cognition and obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internet

Arm Type

Experimental

Arm Description

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.

Arm Title

Printed Manual

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Follow Up Support

Intervention Description

inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training

Primary Outcome Measure Information:

Title

Changes in nutrition- and exercise self-efficacy

Description

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.

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)

Secondary Outcome Measure Information:

Title

Dropout rate

Description

The Dropout rate will be compared by the number of women available for the last meeting at the end of the follw up intervention.

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)

Other Pre-specified Outcome Measures:

Title

Sustainability of weight loss

Description

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)

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)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sonja Rader, Mag.a

Organizational Affiliation

FEM Süd

Official's Role

Principal Investigator

Facility Information:

Facility Name

FEM Süd

City

Vienna

ZIP/Postal Code

1100

Country

Austria

12. IPD Sharing Statement

Links:

URL

http://www.rundum-gsund.at

Description

Homepage of the project (German)

Obesity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial