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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270451
• Other study ID #: 08/302d, 2008/6365 (REK)
• Secondary ID: 08/7772
• Status: Completed
• Phase: N/A
• First received: January 4, 2011
• Last updated: October 22, 2014
• Start date: September 2008
• Est. completion date: September 2012

Study information

• Verified date: October 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Department of Biobank
• Study type: Interventional

Clinical Trial 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

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.

Other known NCT identifiers

• NCT01592591

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Foundation for Health and Rehabilitation, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight regain		2 and 4 years postsurgery	No
Secondary	Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status.		2 and 4 years postsurgery	No