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

NCT ID: NCT01270451

Last Updated: 2014-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-09-30

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

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lifestyle group counseling

Included patients will be randomised into two groups: to the intervention group or to the control group.

Group Type: OTHER

Lifestyle intervention to prevent weight regain

Intervention Type: OTHER

To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Weight maintenance; Prevention of insulin resistance; Prevention of diabetes; Prevention of cardiovascular disease

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Norwegian Foundation for Health and Rehabilitation

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Oslo University Hospital

Anne-Marie Aas

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne-Marie Aas, Phd

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition & Dietetics, Oslo University Hospital, Aker

Helga Refsum, Prof.,MD,PhD

Role: STUDY_DIRECTOR

Dept. of Nutrition, University of Oslo (UiO)

Locations

Oslo University Hospital

Oslo, Oslo County, Norway

Countries

Norway

References

Hanvold SE, Vinknes KJ, Loken EB, Hjartaker A, Klungsoyr O, Birkeland E, Risstad H, Gulseth HL, Refsum H, Aas AM. Does Lifestyle Intervention After Gastric Bypass Surgery Prevent Weight Regain? A Randomized Clinical Trial. Obes Surg. 2019 Nov;29(11):3419-3431. doi: 10.1007/s11695-019-04109-7.

Reference Type: DERIVED

PMID: 31363961 (View on PubMed)

Other Identifiers

08/7772

Identifier Type: OTHER

Identifier Source: secondary_id

08/302d, 2008/6365 (REK)

Identifier Type: -

Identifier Source: org_study_id

NCT01592591

Identifier Type: -

Identifier Source: nct_alias