ObesityNCT01270451
Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery
A study testing Lifestyle intervention to prevent weight regain in people with Obesity, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Lifestyle intervention to prevent weight regain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2008to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who have experienced serious complications due to the bariatric surgery
- Patients who do not understand Norwegian
- Immobile patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery.
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
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.
- Conditions
- Obesity
- Being tested
- Lifestyle intervention to prevent weight regain
- Keywords
- Weight maintenance, Group counseling, Prevention of diseases
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle intervention to prevent weight regainOther
Also called Weight maintenance, Prevention of insulin resistance, Prevention of diabetes, Prevention of cardiovascular disease
To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle group counseling | Other | Included patients will be randomised into two groups: to the intervention group or to the control group. Receives: Other: Lifestyle intervention to prevent weight regain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight regain
Measured: 2 and 4 years postsurgery
Secondary outcomes (1)
Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status.
Measured: 2 and 4 years postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startSep 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Norwegian Foundation for Health and Rehabilitation
- Responsible party
- Principal investigator, Oslo University Hospital, Oslo University Hospital
- Investigators
- Anne-Marie Aas, Phd, Principal investigator, Department of Nutrition & Dietetics, Oslo University Hospital, AkerHelga Refsum, Prof.,MD,PhD, Study director, Dept. of Nutrition, University of Oslo (UiO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270451
- Sponsor's protocol ID
- 08/302d, 2008/6365 (REK)
- Other IDs
- 08/7772
- Status last verified
- Oct 2014
- First submitted
- 4 Jan 2011
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery.
- ClinicalTrials.gov ID
- NCT01270451
- Acronym / sponsor ID
- 08/302d, 2008/6365 (REK)
- Conditions
- Obesity
- Keywords
- Weight maintenance, Group counseling, Prevention of diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Norwegian Foundation for Health and Rehabilitation
- Study start
- Sep 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle group counseling | Other | Other: Lifestyle intervention to prevent weight regainIncluded patients will be randomised into two groups: to the intervention group or to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who have experienced serious complications due to the bariatric surgery
- Patients who do not understand Norwegian
- Immobile patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle intervention to prevent weight regainAlso: Weight maintenance, Prevention of insulin resistance, Prevention of diabetes, Prevention of cardiovascular diseaseTo study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group. | Other | Lifestyle group counseling |
Primary outcome
Weight regain
Time frame: 2 and 4 years postsurgery
1 secondary outcome
Changes in QOL, insulin resistance, diabetes, cardiovascular risk factors, nutritional status.
Time frame: 2 and 4 years postsurgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
- Derived from this study: PubMed 31363961Hanvold 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention to prevent weight regain in people with Obesity, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight regain (time frame: 2 and 4 years postsurgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01270451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2014.