Clinical trial NCT01270451: Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery
Official title: Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight maintenance
Group counseling
Prevention of diseases
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Norwegian Foundation for Health and Rehabilitation
First posted: 2011-01-05
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Weight regain
timeFrame: 2 and 4 years postsurgery
Secondary outcomes:
measure: Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status.
timeFrame: 2 and 4 years postsurgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Department of Nutrition & Dietetics, Oslo University Hospital, Aker
name: Anne-Marie Aas, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Nutrition, University of Oslo (UiO)
name: Helga Refsum, Prof.,MD,PhD
role: STUDY_DIRECTOR
References:
citation: 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.