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

This study is ongoing, but not recruiting participants.
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: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Obesity
 Other: Lifestyle intervention to prevent weight regain

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Weight regain [ Time Frame: 2 and 4 years postsurgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status. [ Time Frame: 2 and 4 years postsurgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: September 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 4, 2011
Last Updated: September 19, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Department of Biobank

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

Additional relevant MeSH terms:
Obesity
Weight Gain
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 16, 2013