Family & Friends - the Significance of a Significant Other in Treatment
June 14, 2016 updated by: Norwegian University of Science and Technology
Conservative Treatment of Obesity at Røros Rehabilitation Centre - A Randomised Trial
This study focuses on the difficulties to maintain a weight loss and behavioural change after having been in a institutional intermittent weight loss programme.
We explore if including a member of the family or a close friend in the treatment influences weight loss maintenance after completion of the programme.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Roros, Norway, 7374
- Roros Rehabiliteringssenter
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Morbid obesity
- 18-50 years of age
- Having a relative or close friend who is willing to participate
Exclusion Criteria:
- Pregnancy
- Serious mental illness
- Severe overeating behaviour
- Significant reduced physical functioning
- Having undergone bariatric surgery earlier
- Serious heart disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Without friend
Being in the weight loss programme without friend or family member
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|
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Experimental: With friend
Having the friend or family member stay together with the patient for 2-3 days for every 3 week stay at the clinic in the weight loss programme
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maintenance of weight loss
Time Frame: 2 years after termination of programme
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2 years after termination of programme
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bård Kulseng, PhD, Norwegian University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
November 9, 2010
First Submitted That Met QC Criteria
November 9, 2010
First Posted (Estimate)
November 10, 2010
Study Record Updates
Last Update Posted (Estimate)
June 16, 2016
Last Update Submitted That Met QC Criteria
June 14, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSSO-2010/2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.