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

October 22, 2014 updated by: Oslo University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight regain
Time Frame: 2 and 4 years postsurgery
2 and 4 years postsurgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status.
Time Frame: 2 and 4 years postsurgery
2 and 4 years postsurgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 4, 2011

First Submitted That Met QC Criteria

January 4, 2011

First Posted (Estimate)

January 5, 2011

Study Record Updates

Last Update Posted (Estimate)

October 23, 2014

Last Update Submitted That Met QC Criteria

October 22, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/302d, 2008/6365 (REK)
  • 08/7772 (Other Identifier: Biobankregisteret)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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