NCT01238354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

4.1 years

First QC Date

November 9, 2010

Last Update Submit

June 14, 2016

Conditions

Obesity

Keywords

Weight LossSocial support

Outcome Measures

Primary Outcomes (1)

  • Maintenance of weight loss

    2 years after termination of programme

Study Arms (2)

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

With friendBEHAVIORAL
With friend
Without friendBEHAVIORAL
Without friend

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Morbid obesity
  • years of age
  • Having a relative or close friend who is willing to participate

You may not qualify if:

  • Pregnancy
  • Serious mental illness
  • Severe overeating behaviour
  • Significant reduced physical functioning
  • Having undergone bariatric surgery earlier
  • Serious heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roros Rehabiliteringssenter

Røros, 7374, Norway

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Bård Kulseng, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 10, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 16, 2016

Record last verified: 2016-06

Locations

NO(1)