| ID | Type | Description | Link |
|---|---|---|---|
| 08/7772 | Other Identifier | Biobankregisteret |
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| Name | Class |
|---|---|
| University of Oslo | OTHER |
| Norwegian Foundation for Health and Rehabilitation | OTHER |
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Primary Outcomes:
To study cross-sectional associations between diet, physical activity, T2DM and weight in subjects 2 yrs after surgery.
To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.
Secondary Outcomes:
To study the association between vit.D levels and T2DM.
To study the association between weight change and QOL.
To validate the new guidance strategy by recording food intake, energy expenditure and physical activity level.
To study if subjects receiving extra guidance in diet and physical activity experience other health effects compared to a control group.
To search for biomarkers that can identify people at risk of increasing weight post surgery
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle group counseling | Other | Included patients will be randomised into two groups: to the intervention group or to the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention to prevent weight regain | Other | To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight regain | 2 and 4 years postsurgery |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status. | 2 and 4 years postsurgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Marie Aas, Phd | Department of Nutrition & Dietetics, Oslo University Hospital, Aker | Principal Investigator |
| Helga Refsum, Prof.,MD,PhD | Dept. of Nutrition, University of Oslo (UiO) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Oslo | 0407 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31363961 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068959 | Body Weight Maintenance |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D049628 | Body Size |
| D006128 | Growth |
| D048788 | Growth and Development |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010829 |
| Physiological Phenomena |