Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lifestyle intervention to prevent weight regain
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Weight maintenance, Group counseling, Prevention of diseases
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing gastric bypass surgery at OUH in the period January 2006 to June 2009 (recruited 24 ± 9 months following surgery)
- Willingness to participate at regular meetings at OUH
Exclusion Criteria:
- Patients who have experienced serious complications due to the bariatric surgery
- Patients who do not understand Norwegian
- Immobile patients
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lifestyle group counseling
Arm Description
Included patients will be randomised into two groups: to the intervention group or to the control group.
Outcomes
Primary Outcome Measures
Weight regain
Secondary Outcome Measures
Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status.
Full Information
NCT ID
NCT01270451
First Posted
January 4, 2011
Last Updated
October 22, 2014
Sponsor
Oslo University Hospital
Collaborators
University of Oslo, Norwegian Foundation for Health and Rehabilitation
1. Study Identification
Unique Protocol Identification Number
NCT01270451
Brief Title
Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery
Official Title
Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo, Norwegian Foundation for Health and Rehabilitation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Outcomes:
To study cross-sectional associations between diet, physical activity, T2DM and weight in subjects 2 yrs after surgery.
To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.
Secondary Outcomes:
To study the association between vit.D levels and T2DM.
To study the association between weight change and QOL.
To validate the new guidance strategy by recording food intake, energy expenditure and physical activity level.
To study if subjects receiving extra guidance in diet and physical activity experience other health effects compared to a control group.
To search for biomarkers that can identify people at risk of increasing weight post surgery
Detailed Description
Expected weight loss after GBP is 60-80% of the overweight. GBP is effective therapy against the obesity-related disorders, including T2DM. Some subjects start gaining weight within 12-18 months after surgery. Weight gain may again increase the risk for developing obesity-related disorders. Previous studies have found a link between vitamin D deficiencies and T2DM. Vitamin D levels will be monitored during the intervention. Studies have shown that patients who underwent GBP experienced a dramatic improvement in quality of life(QOL). After reaching maximum weight loss, many will slowly gain weight. For some people that means a decrease in QOL. In order to prevent weight gain it may be useful to provide additional follow-ups. Participants are randomised into two groups: Group A will receive extra guidance and follow-up, while Group B will continue with the existing scheme. Participants in Group A will over the next 2 yrs take part in frequent meetings. To assess dietary habits, physical activity patterns and QOL, food diaries, physical activity questionnaires and QOL questionnaires are used. Anthropometric and blood pressure measurements will be taken and blood samples will be collected at regular time intervals before and during the study. The results will be used to validate the effect of extra guidance, and to decide if this treatment shall be offered to all of our patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight maintenance, Group counseling, Prevention of diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle group counseling
Arm Type
Other
Arm Description
Included patients will be randomised into two groups: to the intervention group or to the control group.
Intervention Type
Other
Intervention Name(s)
Lifestyle intervention to prevent weight regain
Other Intervention Name(s)
Weight maintenance, Prevention of insulin resistance, Prevention of diabetes, Prevention of cardiovascular disease
Intervention Description
To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.
Primary Outcome Measure Information:
Title
Weight regain
Time Frame
2 and 4 years postsurgery
Secondary Outcome Measure Information:
Title
Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status.
Time Frame
2 and 4 years postsurgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing gastric bypass surgery at OUH in the period January 2006 to June 2009 (recruited 24 ± 9 months following surgery)
Willingness to participate at regular meetings at OUH
Exclusion Criteria:
Patients who have experienced serious complications due to the bariatric surgery
Patients who do not understand Norwegian
Immobile patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Aas, Phd
Organizational Affiliation
Department of Nutrition & Dietetics, Oslo University Hospital, Aker
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helga Refsum, Prof.,MD,PhD
Organizational Affiliation
Dept. of Nutrition, University of Oslo (UiO)
Official's Role
Study Director
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
31363961
Citation
Hanvold SE, Vinknes KJ, Loken EB, Hjartaker A, Klungsoyr O, Birkeland E, Risstad H, Gulseth HL, Refsum H, Aas AM. Does Lifestyle Intervention After Gastric Bypass Surgery Prevent Weight Regain? A Randomized Clinical Trial. Obes Surg. 2019 Nov;29(11):3419-3431. doi: 10.1007/s11695-019-04109-7.
Results Reference
derived
Learn more about this trial
Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery
We'll reach out to this number within 24 hrs