Physical CapacityLEICONCT03593798
Lifestyle Intervention and Physical Capacity in Patients With Morbid Obesity
An observational study of Physical Capacity, run by Sykehuset i Vestfold HF at 2 sites in Norway.
Trial summary
Lifestyle intervention and physical capacity in patients with morbid Obesity (LEICO) Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Capacity
- What is being tested?
- Lifestyle
- How many people
- 200 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Nov 2013to 30 May 2016
- Phase
- Observational
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese patient seeking lifestyle intervention program
Who may be able to join
- Treatment morbidly obese patients (BMI ≥ 40 kg/m2 or BMI 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the Vestfold Hospital Trust.
Who cannot join
- Uncompensated heart failure
- Recent myocardial infarction or stroke (<½ years)
- Severe arrhythmia or heart failure
- Unstable angina pectoris
- Renal failure
- Severe eating disorders
- Active substance abuse
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Telemark University College
Bø, 3800
Vestfold Hospital Trust
Tønsberg, 3103
About this study
Lifestyle intervention and physical capacity in patients with morbid Obesity (LEICO)
Read the detailed description
It is still uncertainty about which is the most effective lifestyle treatment to reducing body weight and increased quality of life. Increased physical capacity and muscle mass lead to increased energy expenditure, thus explaining parts of the difference in weight loss achieved after lifestyle treatment. However, literature in this area is limited and need better documentation of how, and to what extent increased physical capacity can affect the effect of lifestyle treatment offered to patients in the health service.
- Conditions
- Physical Capacity
- Being tested
- Lifestyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifestyleOther
Lifestyle intervention an effect on weight and physical capacity
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change at 1-year follow up
Can physical capacity before start of a routine medical care have a impact on weight loss at 1-year follow-up.
Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and after 1-year follow up.
Changes from baseline body weight at 1-year follow up.
Participants receive interventions as part of routine medical care, and studie the effect of the intervention.
Measured: Changes from baseline body weight at 1-year follow up.
Weight change at 12-weeks follow up
Can physical capacity before start of a routine medical care have a impact on weight loss at 12-weeks follow-up.
Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and after 12-weeks follow up.
Changes from baseline body weight at 12-weeks follow up.
Participants receive interventions as part of routine medical care, and studie the effect of the intervention.
Measured: Changes from baseline body weight at 12-weeks follow up.
Secondary outcomes (1)
Physical capacity changes after 12 weeks as assessed by the maximal oxygen uptake test
Can the mean twelve-week change in physical capacity be associated with weight loss.
The maximal oxygen uptake test was performed as an incremental treadmill test on Woodway ELG 55 (Waukesha, Germany) or, for patients with walking restrictions, on an incremental bicycle test (Lode Corival V3, Lode BV, Groningen, Netherlands). Oxygen uptake was registered using the Jaeger oxycon pro ergospirometry test system (Jaeger Oxycon Pro JLAB 5.x, Hoechberg, Germany).
Changes from baseline physical capacity at 12-weeks follow up.
Measured: Changes from baseline physical capacity at 12-weeks follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Nov 2013
- Primary completion30 May 2016
- Study completion30 May 2016
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 Physical CapacityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- University of South-Eastern Norway
- Responsible party
- Principal investigator, Jarle Berge, Sykehuset i Vestfold HF
- Investigators
- Jens Hertel, PhD, Study director, The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593798
- Sponsor's protocol ID
- LEICO
- Acronym
- LEICO
- Status last verified
- Aug 2018
- First submitted
- 30 Apr 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Berge J, Storen O, Hertel JK, Gjevestad E, Smastuen MC, Hjelmesaeth J. Associations between cardiorespiratory fitness and weight loss in patients with severe obesity undergoing an intensive lifestyle intervention program: retrospective cohort study. BMC Endocr Disord. 2019 Jul 1;19(1):69. doi: 10.1186/s12902-019-0394-z.
PubMed 31262301
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention and Physical Capacity in Patients With Morbid Obesity
- ClinicalTrials.gov ID
- NCT03593798
- Acronym / sponsor ID
- LEICO / LEICO
- Conditions
- Physical Capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- University of South-Eastern Norway
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 20 Jul 2018 (actual)
- 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.
Lifestyle intervention and physical capacity in patients with morbid Obesity (LEICO)
Detailed description
It is still uncertainty about which is the most effective lifestyle treatment to reducing body weight and increased quality of life. Increased physical capacity and muscle mass lead to increased energy expenditure, thus explaining parts of the difference in weight loss achieved after lifestyle treatment. However, literature in this area is limited and need better documentation of how, and to what extent increased physical capacity can affect the effect of lifestyle treatment offered to patients in the health service.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patient seeking lifestyle intervention program
Key inclusion criteria (1 listed)
- Treatment morbidly obese patients (BMI ≥ 40 kg/m2 or BMI 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the Vestfold Hospital Trust.
Key exclusion criteria (7 listed)
- Uncompensated heart failure
- Recent myocardial infarction or stroke (<½ years)
- Severe arrhythmia or heart failure
- Unstable angina pectoris
- Renal failure
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 |
|---|---|---|
| LifestyleLifestyle intervention an effect on weight and physical capacity | Other | – |
Primary outcome
Weight change at 1-year follow up
Time frame: Changes from baseline body weight at 1-year follow up.
Can physical capacity before start of a routine medical care have a impact on weight loss at 1-year follow-up. Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and after 1-year follow up. Changes from baseline body weight at 1-year follow up. Participants receive interventions as part of routine medical care, and studie the effect of the intervention.
Weight change at 12-weeks follow up
Time frame: Changes from baseline body weight at 12-weeks follow up.
Can physical capacity before start of a routine medical care have a impact on weight loss at 12-weeks follow-up. Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and after 12-weeks follow up. Changes from baseline body weight at 12-weeks follow up. Participants receive interventions as part of routine medical care, and studie the effect of the intervention.
1 secondary outcome
Physical capacity changes after 12 weeks as assessed by the maximal oxygen uptake test
Time frame: Changes from baseline physical capacity at 12-weeks follow up.
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 13 Aug 2018.
- Derived from this study: PubMed 31262301Berge J, Storen O, Hertel JK, Gjevestad E, Smastuen MC, Hjelmesaeth J. Associations between cardiorespiratory fitness and weight loss in patients with severe obesity undergoing an intensive lifestyle intervention program: retrospective cohort study. BMC Endocr Disord. 2019 Jul 1;19(1):69. doi: 10.1186/s12902-019-0394-z.
- Individual participant dataSharing planned: Undecided
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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.
Jens Hertel, PhD study director
The Hospital of Vestfold
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Capacity, run by Sykehuset i Vestfold HF at 2 sites 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 1 inclusion and 7 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 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 change at 1-year follow up (time frame: Changes from baseline body weight at 1-year follow up.). The study lists 2 primary outcomes in all. 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 NCT03593798, 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 13 Aug 2018.