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CompletedNCT01270451Updated Oct 23, 2014

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

An interventional study of Lifestyle intervention to prevent weight regain in Obesity, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-23.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Obesity

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Keywords

  • Weight maintenance
  • Group counseling
  • Prevention of diseases
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 165 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 830 studies on the registry; 146 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients who have experienced serious complications due to the bariatric surgery
  • Patients who do not understand Norwegian
  • Immobile patients
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
165 participants (actual)

Study arms

  • Other
    Lifestyle group counseling

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

    Other: Lifestyle intervention to prevent weight regain

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.

    Also known as: Weight maintenance, Prevention of insulin resistance, Prevention of diabetes, Prevention of cardiovascular disease

06

What researchers measure

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

07

Study locations

1 site
  • Oslo University Hospital
    Oslo, Oslo 0407, Norway
08

References and documents

Publications

  • 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. PubMed 31363961 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2008, a primary completion of Sep 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2011
First posted
Jan 5, 2011
Start
Sep 2008
Primary completionActual
Sep 2012
CompletionActual
Sep 2012
Last update
Oct 23, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01270451
Collaborators
University of Oslo, Norwegian Foundation for Health and Rehabilitation
Responsible party
Oslo University Hospital (Anne-Marie Aas, Oslo University Hospital) — Principal investigator
First posted
Jan 5, 2011
Start date
Sep 2008
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Oct 23, 2014

Study contacts

Anne-Marie Aas, Phd
principal investigator · Department of Nutrition & Dietetics, Oslo University Hospital, Aker
Helga Refsum, Prof.,MD,PhD
study director · Dept. of Nutrition, University of Oslo (UiO)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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