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

  • Norway
      • Roros, Norway, 7374
        • Roros Rehabiliteringssenter

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
Active Comparator: Without friend
Being in the weight loss programme without friend or family member
Behavioral: Without friend
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
Behavioral: With friend

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maintenance of weight loss
Time Frame: 2 years after termination of programme
2 years after termination of programme

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

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.

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