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Maintenance Programme After Weight Loss

Primary Purpose

Weight Loss, Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
weight loss programme with maintenance programme
weight loss programme
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring maintenance therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI 35 kg/m2 or more
  • Age 18-65 years

Exclusion Criteria:

  • Type 1 diabetes
  • Major alcohol problem
  • Acute psychic disease, eating behavior, pregnancy, severe disease (cancer, unstable coronary disease, severe liver or kidney disease), or the patient has been in this treatment within the past 5 years

Sites / Locations

  • Peijas Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2

1

Arm Description

Treatment B includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). Treatment lasts 17 weeks and after that there will be one and two year control visits including weighing and questionnaires for eating behavior and quality of life.

Treatment includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). After that a maintenance programme starts with monthly sessions for one year. Weight loss, quality of life, and eating behavior will be assessed at the end of the maintenance program and one year later.

Outcomes

Primary Outcome Measures

weight result

Secondary Outcome Measures

quality of life and eating behavior

Full Information

First Posted
December 26, 2007
Last Updated
January 9, 2008
Sponsor
University of Helsinki
Collaborators
Finnish Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00590655
Brief Title
Maintenance Programme After Weight Loss
Official Title
Effect of Maintenance Programme on the Long Term Weight Reduction in Severely Obese Patients. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Helsinki
Collaborators
Finnish Medical Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare a weight reduction programme with and without a maintenance programme in patients with severe obesity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Morbid Obesity
Keywords
maintenance therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment B includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). Treatment lasts 17 weeks and after that there will be one and two year control visits including weighing and questionnaires for eating behavior and quality of life.
Arm Title
1
Arm Type
Experimental
Arm Description
Treatment includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). After that a maintenance programme starts with monthly sessions for one year. Weight loss, quality of life, and eating behavior will be assessed at the end of the maintenance program and one year later.
Intervention Type
Behavioral
Intervention Name(s)
weight loss programme with maintenance programme
Intervention Description
After usual weight loss treatment, there will be a one-year maintenance programme with monthly visits.
Intervention Type
Behavioral
Intervention Name(s)
weight loss programme
Primary Outcome Measure Information:
Title
weight result
Time Frame
2 years after weight loss phase
Secondary Outcome Measure Information:
Title
quality of life and eating behavior
Time Frame
2 years after active weight loss

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI 35 kg/m2 or more Age 18-65 years Exclusion Criteria: Type 1 diabetes Major alcohol problem Acute psychic disease, eating behavior, pregnancy, severe disease (cancer, unstable coronary disease, severe liver or kidney disease), or the patient has been in this treatment within the past 5 years
Facility Information:
Facility Name
Peijas Hospital
City
Vantaa
ZIP/Postal Code
01400
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25918644
Citation
Pekkarinen T, Kaukua J, Mustajoki P. Long-term weight maintenance after a 17-week weight loss intervention with or without a one-year maintenance program: a randomized controlled trial. J Obes. 2015;2015:651460. doi: 10.1155/2015/651460. Epub 2015 Mar 30.
Results Reference
derived

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Maintenance Programme After Weight Loss

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