Overweight and ObesityLEVA-POPNCT04184479
Effect of the LEVAmethod by Bertz et al © in Subjects With Overweight or Obesity in Primary Health Care.
A study testing LEVAmethod by Bertz et al in people with Overweight and Obesity, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
This study evaluates weight loss effect of the method LEVA by Bertz et al in subjects with overweight or obesity that are remitted to Primärvårdens Dietistenhet. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- LEVAmethod by Bertz et al
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 2 Dec 2020to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 27 ≤ 35
- age 18-75 år
Who cannot join
- difficulty understanding Swedish, spoken or read
- does not manage/want to handle digital Tools
- the remittance was addressed to Primärvårdens Dietistenhet at wrong premises and the patient should be treated elsewhere.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Västra Götalandsregionen
Gothenburg
Else Johansson, +46768871219, else.hellebo.johansson@vgregion.se
About this study
Official title: Placebo-Controlled, Randomized Weight Loss InterventionTrial in Subjects With Overweight or Obesity in Primary Health Care
This study evaluates weight loss effect of the method LEVA by Bertz et al in subjects with overweight or obesity that are remitted to Primärvårdens Dietistenhet.
Read the detailed description
The method "Lifestyle at Effective Weight Loss During Breastfeeding" (LEVA method by Bertz et al) has been scientifically studied to provide sustainable weight loss for women with overweight or obesity after childbirth. Primary health care centers in Västra Götalandsregionen treat adult patients with overweight and obesity. If the LEVA method by Bertz et el also produces weight loss to other patient groups than women post partum, the method could be used as a treatment alternative.
- Conditions
- Overweight and Obesity
- Being tested
- LEVAmethod by Bertz et al
- Keywords
- overweight, randomized controlled trial, obesity, weight loss, weight loss maintenance
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEVAmethod by Bertz et alBehavioural
Also called Ordinary treatment
Ordinary treatment
| Study group | Role | What they receive |
|---|---|---|
| A-LEVAmetoden by Bertz et al | Active comparator | Individual dietary advices for weight loss, based on the participants' food record of 4 consecutive days aimed to achieve an energy intake reduction of 500 kcal/d with a nutrient composition according to the Nordic Nutrition Recommendations. Follow up visits after 3 months, 1 year and 2 years after baseline. Follow up by electronic platform every other week until 3 months after baseline and each month after 3 months until 1 year after baseline. Receives: Behavioral: LEVAmethod by Bertz et al |
| B-Ordinary treatment | Placebo comparator | Dietary advices for weight loss aimed to achieve calorie restriction. Follow up visits after 3 months, 1 year and 2 years after baseline. Additional visits, up to 4 times in the first year after baseline. Receives: Behavioral: LEVAmethod by Bertz et al |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of weight between intervention group and placebo
Weight in kg measured at visits
Measured: From baseline and 12 weeks
Change of weight between intervention group and placebo
Weight in kg measured at visits
Measured: From baseline and 1 year
Change of weight between intervention group and placebo
Weight in kg measured at visits
Measured: From baseline and 2 year
Secondary outcomes (12)
Gender differences in weight loss results
weight in kg measured at visits in relation to gender
Measured: From baseline to 12 weeks
Gender differences in weight loss results
weight in kg measured at visits in relation to gender
Measured: From baseline to 1 year
Gender differences in weight loss results
weight in kg measured at visits in relation to gender
Measured: From baseline to 2 year
Age differences in weight loss results
Weight in kg measured at visits in relation to age
Measured: From baseline to 12 weeks
Age differences in weight loss results
Weight in kg measured at visits in relation to age
Measured: From baseline to 1 years
Age differences in weight loss results
Weight in kg measured at visits in relation to age
Measured: From baseline to 2 years
Weight loss result in relation to pre-treatment BMI
Weight in kg measured at visits in relation to pre-treatment BMI
Measured: From baseline to 12 weeks
Weight loss result in relation to pre-treatment BMI
Weight in kg measured at visits in relation to pre-treatment BMI
Measured: From baseline to 1 year
Weight loss result in relation to pre-treatment BMI
Weight in kg measured at visits in relation to pre-treatment BMI
Measured: From baseline to 2 year
Cost-effectiveness of LEVA method by Bertz et al
Calculation of cost-effectiveness by the method of monetary net benefit
Measured: From baseline to 12 weeks
Cost-effectiveness of LEVA method by Bertz et al
Calculation of cost-effectiveness by the method of monetary net benefit
Measured: From baseline to 1 year
Cost-effectiveness of LEVA method by Bertz et al
Calculation of cost-effectiveness by the method of monetary net benefit
Measured: From baseline to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start2 Dec 2020
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Else Johansson, Principal investigator, Västra Götalandsregionen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184479
- Sponsor's protocol ID
- LEVA-POP
- Acronym
- LEVA-POP
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2019
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Randomized Weight Loss InterventionTrial in Subjects With Overweight or Obesity in Primary Health Care
- ClinicalTrials.gov ID
- NCT04184479
- Acronym / sponsor ID
- LEVA-POP / LEVA-POP
- Conditions
- Overweight and Obesity
- Keywords
- overweight, randomized controlled trial, obesity, weight loss, weight loss maintenance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Dec 2019 (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.
This study evaluates weight loss effect of the method LEVA by Bertz et al in subjects with overweight or obesity that are remitted to Primärvårdens Dietistenhet.
Detailed description
The method "Lifestyle at Effective Weight Loss During Breastfeeding" (LEVA method by Bertz et al) has been scientifically studied to provide sustainable weight loss for women with overweight or obesity after childbirth. Primary health care centers in Västra Götalandsregionen treat adult patients with overweight and obesity. If the LEVA method by Bertz et el also produces weight loss to other patient groups than women post partum, the method could be used as a treatment alternative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-LEVAmetoden by Bertz et al | Active comparator | Behavioral: LEVAmethod by Bertz et alIndividual dietary advices for weight loss, based on the participants' food record of 4 consecutive days aimed to achieve an energy intake reduction of 500 kcal/d with a nutrient composition according to the Nordic Nutrition Recommendations. Follow up visits after 3 months, 1 year and 2 years after baseline. Follow up by electronic platform every other week until 3 months after baseline and each month after 3 months until 1 year after baseline. |
| B-Ordinary treatment | Placebo comparator | Behavioral: LEVAmethod by Bertz et alDietary advices for weight loss aimed to achieve calorie restriction. Follow up visits after 3 months, 1 year and 2 years after baseline. Additional visits, up to 4 times in the first year after baseline. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 27 ≤ 35
- age 18-75 år
Key exclusion criteria (3 listed)
- difficulty understanding Swedish, spoken or read
- does not manage/want to handle digital Tools
- the remittance was addressed to Primärvårdens Dietistenhet at wrong premises and the patient should be treated elsewhere.
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 |
|---|---|---|
| LEVAmethod by Bertz et alAlso: Ordinary treatmentOrdinary treatment | Behavioural | A-LEVAmetoden by Bertz et al, B-Ordinary treatment |
Primary outcome
Change of weight between intervention group and placebo
Time frame: From baseline and 12 weeks
Weight in kg measured at visits
Change of weight between intervention group and placebo
Time frame: From baseline and 1 year
Weight in kg measured at visits
Change of weight between intervention group and placebo
Time frame: From baseline and 2 year
Weight in kg measured at visits
12 secondary outcomes
Gender differences in weight loss results
Time frame: From baseline to 12 weeks
Gender differences in weight loss results
Time frame: From baseline to 1 year
Gender differences in weight loss results
Time frame: From baseline to 2 year
Age differences in weight loss results
Time frame: From baseline to 12 weeks
Age differences in weight loss results
Time frame: From baseline to 1 years
Age differences in weight loss results
Time frame: From baseline to 2 years
Weight loss result in relation to pre-treatment BMI
Time frame: From baseline to 12 weeks
Weight loss result in relation to pre-treatment BMI
Time frame: From baseline to 1 year
Weight loss result in relation to pre-treatment BMI
Time frame: From baseline to 2 year
Cost-effectiveness of LEVA method by Bertz et al
Time frame: From baseline to 12 weeks
Cost-effectiveness of LEVA method by Bertz et al
Time frame: From baseline to 1 year
Cost-effectiveness of LEVA method by Bertz et al
Time frame: From baseline to 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Else Johansson principal investigator
Västra Götalandsregionen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEVAmethod by Bertz et al in people with Overweight and Obesity, run by Vastra Gotaland Region at 1 site in Sweden.
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: looking for participants now, as of the sponsor's last update on 25 Nov 2024. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Else Johansson (+46768871219, else.hellebo.johansson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of weight between intervention group and placebo (time frame: From baseline and 12 weeks). The study lists 3 primary outcomes in all. 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 25 Nov 2024.