NCT01270451

Brief Summary

Primary Outcomes:

  1. 1.To study cross-sectional associations between diet, physical activity, T2DM and weight in subjects 2 yrs after surgery.
  2. 2.To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.
  3. 3.To study the association between vit.D levels and T2DM.
  4. 4.To study the association between weight change and QOL.
  5. 5.To validate the new guidance strategy by recording food intake, energy expenditure and physical activity level.
  6. 6.To study if subjects receiving extra guidance in diet and physical activity experience other health effects compared to a control group.
  7. 7.To search for biomarkers that can identify people at risk of increasing weight post surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 23, 2014

Status Verified

October 1, 2014

Enrollment Period

4 years

First QC Date

January 4, 2011

Last Update Submit

October 22, 2014

Conditions

Obesity

Keywords

Weight maintenanceGroup counselingPrevention of diseases

Outcome Measures

Primary Outcomes (1)

  • Weight regain

    2 and 4 years postsurgery

Secondary Outcomes (1)

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

    2 and 4 years postsurgery

Study Arms (1)

Lifestyle group counseling

OTHER

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

Lifestyle intervention to prevent weight regainOTHER

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
Lifestyle group counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0407, Norway

Location

Related Publications (1)

  • 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.

    PMID: 31363961DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Body Weight Maintenance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body WeightBody SizeGrowthGrowth and DevelopmentPhysiological Phenomena

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anne-Marie Aas

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 5, 2011

Study Start

September 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 23, 2014

Record last verified: 2014-10

Locations

NO(1)