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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
With friend
Without friend
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring Weight Loss, Social support

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roros Rehabiliteringssenter

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Without friend

With friend

Arm Description

Being in the weight loss programme without friend or family member

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

Outcomes

Primary Outcome Measures

Maintenance of weight loss

Secondary Outcome Measures

Full Information

First Posted
November 9, 2010
Last Updated
June 14, 2016
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01238354
Brief Title
Family & Friends - the Significance of a Significant Other in Treatment
Official Title
Conservative Treatment of Obesity at Røros Rehabilitation Centre - A Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight Loss, Social support

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Without friend
Arm Type
Active Comparator
Arm Description
Being in the weight loss programme without friend or family member
Arm Title
With friend
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
With friend
Intervention Type
Behavioral
Intervention Name(s)
Without friend
Primary Outcome Measure Information:
Title
Maintenance of weight loss
Time Frame
2 years after termination of programme

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bård Kulseng, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roros Rehabiliteringssenter
City
Roros
ZIP/Postal Code
7374
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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