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OpenTrials
Completed

NCT Number: NCT01270451

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Weight maintenance, Prevention of insulin resistance, Prevention of diabetes, Prevention of cardiovascular disease

Primary outcomes

  1. Weight regain

    Time frame: 2 and 4 years postsurgery

Secondary outcomes

  1. Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status.

    Time frame: 2 and 4 years postsurgery

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Foundation for Health and Rehabilitation
  • University of Oslo

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 5, 2011
Registry last updated
Oct 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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