NCT01675687

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

2.1 years

First QC Date

August 28, 2012

Last Update Submit

March 6, 2015

Conditions

Keywords

dietary habits and obesityexercise habits and obesitycognition and obesity

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Dropout rate

    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 Outcomes (1)

  • Sustainability of weight loss

    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)

Study Arms (2)

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.

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.

Behavioral: Follow Up Support

Interventions

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

InternetPrinted Manual

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FEM Süd

Vienna, 1100, Austria

Location

Related Links

MeSH Terms

Conditions

ObesityFeeding Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Sonja Rader, Mag.a

    FEM Süd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2012

First Posted

August 30, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations