Physical CapacityLIFETIMENCT03593148
The Effect of Lifestyle Treatment in Patients With Morbid Obesity
A study testing Lifestyle in people with Physical Capacity and Leg Strength, run by Sykehuset i Vestfold HF at 1 site in Norway.
Trial summary
The effect of lifestyle treatment on physical capacity, maximal strength, eating behavior and quality of life in patients with morbid obesity (LIFETIME) 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, Leg Strength, Eating Behavior
- What is being tested?
- Lifestyle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2017to 23 Dec 2025
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Treatment seeking 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
- Pregnancy
- Severe eating disorders
- Active substance abuse
Trial locations and contacts
1 site in 1 country.
Jens Hertel, PhD contact
Norway1 site, 1 recruiting
- Recruiting
Jarle Berge
Tønsberg, 3103
Jarle Berge, 33134111, jarle.berge@siv.no
About this study
Official title: The Effect of Lifestyle Treatment on Physical Capacity, Maximal Strength, Eating Behavior and Quality of Life in Patients With Morbid Obesity
The effect of lifestyle treatment on physical capacity, maximal strength, eating behavior and quality of life in patients with morbid obesity (LIFETIME)
Read the detailed description
In this study, the investigators will investigate whether more intensive day-based lifestyle treatment process have a better effect on weight loss and health-related quality of life than a previous treatment. Investigators also want to investigate whether patients with good physical capacity (maximal oxygen uptake) and bone strength (maximum bone strength) before initiating treatment and / or after 3 and 6 months intensive training may have greater weight loss 1 and 2 years after treatment than patients with lower physical capacity and bone strength.
- Conditions
- Physical Capacity, Leg Strength, Eating Behavior, Life of Quality
- Being tested
- Lifestyle
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifestyleOther
Lifestyle treatment
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle treatment | Other | Patients will be included in the Lifestyle treatment that is a existing treatment program at Vestfold Hospital Trust. Receives: Other: Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change at 2-year follow up
Effect of intensive treatment on weight loss changes at 2- year follow up.
Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and at 2-year follow up.
Measured: Changes from baseline body weight at 2-year follow up.
Secondary outcomes (9)
Maximal leg strength change at 2-year follow up
Maximum leg strength will be measure with a bone press device (OPS161 Interchangeable Leg Press) at baseline, after 3-6 month and 1-2 years. The test will be conduct as an individual adapted protocol with gradual loading until voluntary maximum bone strength is achieve.
Measured: Changes from baseline maximal leg strenght at 2-year follow up.
Physical capacity change at 2-year follow up
Physical capacity will be measure as maximum oxygen uptake (VO2max) by indirect calorimetry (Jaeger Oxycone Pro) at baseline, after 3-6 month and 1-2 years. Indirect calorimetry is to be regard as a gold standard for measurement of maximum oxygen uptake.
Measured: Changes from baseline physical capacity at 2-year follow up.
Health-related quality of life (HRQoL) - Short Form Health Survey (RAND-36), change at 2-year follow up
The patient reported outcome measurements (PROMS) comprise three elements; generic and obesity specific health related quality of life (HRQoL) and obesity specific symptoms measured at baseline, 3 months, 6 months, 1 year and 2 years.
The RAND-36 is a 36-item measure of generic HRQOL consisting of eight additive subscales (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health) and two summary scores each based on four subscales (Physical Component Summary and Mental Component Summary). Scores on all subscales range from 0 to 100. Summary-scores will be norm-based, with mean (SD) 50 (10). Higher scores on all scales represent better HRQOL.
Measured: Changes from baseline RAND-36 at 2-year follow up.
Health-related quality of life (HRQoL) - Impact on Weight Questionnaire (IWQOL-Lite), change at 2-year follow up
The patient reported outcome measurements (PROMS) comprise three elements; generic and obesity specific health related quality of life (HRQoL) and obesity specific symptoms measured at baseline, 3 months, 6 months, 1 year and 2 years.
The IWQOL-Lite is a 31-item measure of weight-related quality of life. There are five domain scores (Physical Function, Self-Esteem, Sexual Life, Public Distress and Work) and a total score. Scores for all domains and total score range from 0-100, with lower scores indicating greater impairment.
Measured: Changes from baseline IWQOL-Lite at 2-year follow up.
Health-related quality of life (HRQoL) - Weight-Related Symptom Measure (WRSM), change at 2-year follow up
The patient reported outcome measurements (PROMS) comprise three elements; generic and obesity specific health related quality of life (HRQoL) and obesity specific symptoms measured at baseline, 3 months, 6 months, 1 year and 2 years.
The WRSM is a 20-item measure for the presence and distress of 20 weight-related symptoms. The distress scores of the symptoms are reported on a six-point likert scale. Two summary scores are calculated; an additive score of presence of symptoms ranging from 1 to 20 and a symptom distress score for all symptoms. Symptom distress scores range from 0 to 100, with higher scores indicating a higher or worse total symptom distress.
Measured: Changes from baseline WRSM at 2-year follow up.
Binge Eating Scale (BES), change at 2-year follow up
The patient reported outcome measurements (PROMS) eating behavior at baseline, 3 months, 6 months, 1 year and 2 years.
The Binge Eating Scale comprise 16 items assessing binge eating problems. Additive scores range between 0-46, with higher scores indicating greater problems. Cut-off scores have been established to determine binge severity, with "severe" represented by scores > 27, "moderate" by scores 18-26, and "mild-none" by scores < 17.
Measured: Changes from baseline BES at 2-year follow up.
The Power of Food scale (PFS) change at 2-year follow up
The patient reported outcome measurements (PROMS) eating behavior at baseline, 3 months, 6 months, 1 year and 2 years.
The Power of Food scale assess both the psychological impact and respondent's responsiveness to a food-abundant environment. This is a 15-item scale whose items pertain to three situations: food being readily available in the environment but not physically present, food is physically present, but not tasted, and food is first tasted but not already consumed. The three subscales is scored 0-100 with higher scores indicating greater eating problems.
Measured: Changes from baseline PES at 2-year follow up.
Weight change at 1-year follow up
Effect of intensive treatment on weight loss changes after 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 at 1-year follow up.
Measured: Changes from baseline body weight at 1-year follow up.
Three Factor Eating Questionnaire (TFEQ - R21)
The patient reported outcome measurements (PROMS) eating behavior at baseline, 3 months, 6 months, 1 year and 2 years.
TFEQ-R21 consists of 21 questions that measure cognitive and emotional conditions related to food intake, as well as degree of control over food intake. Each item scores either 0 or 1 point.
Measured: Changes from baseline TFEQ-R21 at 2-year follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Apr 2017
- Primary completion23 Dec 2025 (estimated)
- Study completion23 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
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, Principal investigator, The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593148
- Sponsor's protocol ID
- LIFETIME
- Acronym
- LIFETIME
- Status last verified
- Aug 2021
- First submitted
- 30 Apr 2018
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lifestyle Treatment on Physical Capacity, Maximal Strength, Eating Behavior and Quality of Life in Patients With Morbid Obesity
- ClinicalTrials.gov ID
- NCT03593148
- Acronym / sponsor ID
- LIFETIME / LIFETIME
- Conditions
- Physical Capacity, Leg Strength, Eating Behavior, Life of Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- University of South-Eastern Norway
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 23 Dec 2025 (estimated)
- Study completion
- 23 Dec 2025 (estimated)
- First posted
- 19 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.
The effect of lifestyle treatment on physical capacity, maximal strength, eating behavior and quality of life in patients with morbid obesity (LIFETIME)
Detailed description
In this study, the investigators will investigate whether more intensive day-based lifestyle treatment process have a better effect on weight loss and health-related quality of life than a previous treatment. Investigators also want to investigate whether patients with good physical capacity (maximal oxygen uptake) and bone strength (maximum bone strength) before initiating treatment and / or after 3 and 6 months intensive training may have greater weight loss 1 and 2 years after treatment than patients with lower physical capacity and bone strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle treatment | Other | Other: LifestylePatients will be included in the Lifestyle treatment that is a existing treatment program at Vestfold Hospital Trust. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Treatment seeking 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 (8 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 treatment | Other | Lifestyle treatment |
Primary outcome
Weight change at 2-year follow up
Time frame: Changes from baseline body weight at 2-year follow up.
Effect of intensive treatment on weight loss changes at 2- year follow up. Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and at 2-year follow up.
9 secondary outcomes
Maximal leg strength change at 2-year follow up
Time frame: Changes from baseline maximal leg strenght at 2-year follow up.
Physical capacity change at 2-year follow up
Time frame: Changes from baseline physical capacity at 2-year follow up.
Health-related quality of life (HRQoL) - Short Form Health Survey (RAND-36), change at 2-year follow up
Time frame: Changes from baseline RAND-36 at 2-year follow up.
Health-related quality of life (HRQoL) - Impact on Weight Questionnaire (IWQOL-Lite), change at 2-year follow up
Time frame: Changes from baseline IWQOL-Lite at 2-year follow up.
Health-related quality of life (HRQoL) - Weight-Related Symptom Measure (WRSM), change at 2-year follow up
Time frame: Changes from baseline WRSM at 2-year follow up.
Binge Eating Scale (BES), change at 2-year follow up
Time frame: Changes from baseline BES at 2-year follow up.
The Power of Food scale (PFS) change at 2-year follow up
Time frame: Changes from baseline PES at 2-year follow up.
Weight change at 1-year follow up
Time frame: Changes from baseline body weight at 1-year follow up.
Three Factor Eating Questionnaire (TFEQ - R21)
Time frame: Changes from baseline TFEQ-R21 at 2-year follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- 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 contact
Jens Hertel, PhD principal investigator
The Hospital of Vestfold
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 in people with Physical Capacity and Leg Strength, run by Sykehuset i Vestfold HF 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 1 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jarle Berge (+47 33134111, jarle.berge@siv.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change at 2-year follow up (time frame: Changes from baseline body weight at 2-year follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2021.