NCT00590655

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2002

Longer than P75 for not_applicable

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

August 1, 2002

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
Last Updated

January 10, 2008

Status Verified

December 1, 2007

First QC Date

December 26, 2007

Last Update Submit

January 9, 2008

Conditions

Keywords

maintenance therapy

Outcome Measures

Primary Outcomes (1)

  • weight result

    2 years after weight loss phase

Secondary Outcomes (1)

  • quality of life and eating behavior

    2 years after active weight loss

Study Arms (2)

2

ACTIVE COMPARATOR

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.

Behavioral: weight loss programme

1

EXPERIMENTAL

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.

Behavioral: weight loss programme with maintenance programme

Interventions

After usual weight loss treatment, there will be a one-year maintenance programme with monthly visits.

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peijas Hospital

Vantaa, 01400, Finland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Weight LossObesity, Morbid

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 10, 2008

Study Start

August 1, 2002

Study Completion

May 1, 2006

Last Updated

January 10, 2008

Record last verified: 2007-12

Locations