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: May 22, 2014
Last verified: May 2014
  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:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 22, 2014
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 July 24, 2014