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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01270451

Enrollment

165

Registered

2011-01-05

Start date

2008-09-30

Completion date

2012-09-30

Last updated

2014-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Weight maintenance, Group counseling, Prevention of diseases

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.

Interventions

OTHERLifestyle 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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Weight regain	2 and 4 years postsurgery

Secondary

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026