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Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery

This study has been completed.
Sponsor:
Collaborators:
University of Oslo
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01270451
First received: January 4, 2011
Last updated: October 22, 2014
Last verified: October 2014

January 4, 2011
October 22, 2014
September 2008
September 2012   (final data collection date for primary outcome measure)
Weight regain [ Time Frame: 2 and 4 years postsurgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01270451 on ClinicalTrials.gov Archive Site
Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status. [ Time Frame: 2 and 4 years postsurgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery
Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery.

Primary Outcomes:

  1. To study cross-sectional associations between diet, physical activity, T2DM and weight in subjects 2 yrs after surgery.
  2. To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.

    Secondary Outcomes:

  3. To study the association between vit.D levels and T2DM.
  4. To study the association between weight change and QOL.
  5. To validate the new guidance strategy by recording food intake, energy expenditure and physical activity level.
  6. To study if subjects receiving extra guidance in diet and physical activity experience other health effects compared to a control group.
  7. To search for biomarkers that can identify people at risk of increasing weight post surgery

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
Other: Lifestyle intervention to prevent weight regain
To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.
Other Names:
  • Weight maintenance
  • Prevention of insulin resistance
  • Prevention of diabetes
  • Prevention of cardiovascular disease
Lifestyle group counseling
Included patients will be randomised into two groups: to the intervention group or to the control group.
Intervention: Other: Lifestyle intervention to prevent weight regain
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01270451
08/302d, 2008/6365 (REK), 08/7772
No
Oslo University Hospital
Oslo University Hospital
  • University of Oslo
  • Norwegian Foundation for Health and Rehabilitation
Principal Investigator: Anne-Marie Aas, Phd Department of Nutrition & Dietetics, Oslo University Hospital, Aker
Study Director: Helga Refsum, Prof.,MD,PhD Dept. of Nutrition, University of Oslo (UiO)
Oslo University Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP