NCT02938338

Brief Summary

The aim is to examine the energy consumption before and after bariatric surgery. The study will contribute to the knowledge if operations should be complemented by interventions to increase energy expenditure, mainly by reducing sedentary. as input for the design of an intervention to reduce sedentary. Such intervention should be based on knowledge of the mediators of physical activity among the subjects that need to be strengthened.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

3.5 years

First QC Date

April 28, 2015

Last Update Submit

October 17, 2016

Conditions

Sedentary Lifestyle

Outcome Measures

Primary Outcomes (2)

  • Calories consumed

    Amount calories consumed per day

    One year after surgery

  • Hours sedentary

    Hours sedentary during a day

    One year after surgery

Secondary Outcomes (1)

  • Mediators of physical activity

    One year after surgery

Study Arms (1)

Obese patients with BMI above 35

Bariatric surgery

Procedure: Bariatric surgery

Interventions

Bariatric surgeryPROCEDURE

Bariatric surgery, with an anticipated mean weight loss of 30 kg

Obese patients with BMI above 35

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing bariatric surgery

You may qualify if:

  • All patient at Lindesbergs hospital that get bariatric surgery (a limit to get the surgery is BMI above 35)

You may not qualify if:

  • Not understanding Swedish or English
  • Not the first bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Örebro län

Örebro, Örebro County, SE-70113, Sweden

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Lars A Hagberg, PhD

    Region Örebro County

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars A Hagberg, PhD

CONTACT

+46196027058lars.hagberg@regionorebrolan.se

Eva Carlsson, PhD

CONTACT

+4658185450eva.carlsson@regionorebrolan.se

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 28, 2015

First Posted

October 19, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

SE(1)