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Family & Friends - the Significance of a Significant Other in Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01238354
First received: November 9, 2010
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Behavioral: With friend
Behavioral: Without friend

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Conservative Treatment of Obesity at Røros Rehabilitation Centre - A Randomised Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Maintenance of weight loss [ Time Frame: 2 years after termination of programme ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238354

Locations
Norway
Roros Rehabiliteringssenter
Roros, Norway, 7374
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Bård Kulseng, PhD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01238354     History of Changes
Other Study ID Numbers: RSSO-2010/2, REK 2010/698
Study First Received: November 9, 2010
Last Updated: April 24, 2013
Health Authority: Norway: Ethics Committee

Keywords provided by Norwegian University of Science and Technology:
Weight Loss
Social support

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013