Family & Friends - the Significance of a Significant Othe... | NCT01238354

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

NCT01238354

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Jun 16, 2016Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

With friend
Without friend

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Nov 9, 2010

First Submission Date that Met QC Criteria

Nov 9, 2010

First Posted Date

Nov 10, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2016

Last Update Posted Date

Jun 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Without friend	Active Comparator	Being in the weight loss programme without friend or family member	Behavioral: Without friend
With friend	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
With friend	Behavioral		With friend
Without friend

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bård Kulseng, PhD	Norwegian University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Roros Rehabiliteringssenter		Røros		7374	Norway

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D015431	Weight Loss

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided