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

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ClinicalTrials.gov Identifier: NCT01270451
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : October 23, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

Condition or disease Intervention/treatment
Obesity Other: Lifestyle intervention to prevent weight regain

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery.
Study Start Date : September 2008
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Lifestyle group counseling
Included patients will be randomised into two groups: to the intervention group or to the control group.
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


Outcome Measures

Primary Outcome Measures :
  1. Weight regain [ Time Frame: 2 and 4 years postsurgery ]

Secondary Outcome Measures :
  1. Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status. [ Time Frame: 2 and 4 years postsurgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270451


Locations
Norway
Oslo University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Norwegian Foundation for Health and Rehabilitation
Investigators
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)
More Information

Responsible Party: Oslo University Hospital, Anne-Marie Aas
ClinicalTrials.gov Identifier: NCT01270451     History of Changes
Obsolete Identifiers: NCT01592591
Other Study ID Numbers: 08/302d, 2008/6365 (REK)
08/7772 ( Other Identifier: Biobankregisteret )
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: October 23, 2014
Last Verified: October 2014

Keywords provided by Oslo University Hospital:
Weight maintenance
Group counseling
Prevention of diseases

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms