The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects

• Sponsor: The Hospital of Vestfold (Other)
• Overall Status: Completed
• CT.gov ID: NCT00273104
• Collaborator: South-Eastern Norway Regional Health Authority (Other)
• Enrollment: 180
• Location: 1
• Arms: 2
• Duration (Months): 144
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This follow up study (>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea; Diabetes Mellitus; Hypertension	Procedure: Bariatric surgery; Behavioral: Intensive lifestyle intervention	N/A

Detailed Description

Not addressed

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Lifestyle Intervention vs Gastric Bypass on Various Comorbidities
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bariatric surgery Bariatric surgery (gastric bypass) offered to patients after informed consent and shared decision. The surgical procedure was performed at Vestfold Hospital Trust by experienced bariatric surgeons.	Procedure: Bariatric surgery; Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.
Active Comparator: Intensive lifestyle intervention Intensive lifestyle intervention (1-year endurance) at a rehabilitation centre. The intervention consisted of motivation for behaviour change including calorie restriction and increased physical activity.	Behavioral: Intensive lifestyle intervention; Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.

Outcome Measures

Primary Outcome Measures

1. Improvement of co-morbidities [1-year after treatment start]

   1-year comparative nonrandomized controlled trial

Secondary Outcome Measures

1. Safety issues [1-year]

   Surgical complications and serious adverse events in both groups as published

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Morbidly obese patients

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital in Vestfold	Tonsberg		Norway	3117

Sponsors and Collaborators

• The Hospital of Vestfold
• South-Eastern Norway Regional Health Authority

Investigators

• Principal Investigator: Jøran Hjelmesæth, MD PhD, Hospital of Vestfold

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jøran Hjelmesæth, Head of Morbid Obesity Centre, The Hospital of Vestfold
• ClinicalTrials.gov Identifier: NCT00273104
• Other Study ID Numbers: S-05175
• First Posted: Jan 9, 2006
• Last Update Posted: Apr 19, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Sleep Apnea, Obstructive

Study Results

No Results Posted as of Apr 19, 2018