Effect of the LEVAmethod by Bertz et al © in Subjects With Overweight or Obesity in Primary Health Care.
LEVA-POP
Placebo-Controlled, Randomized Weight Loss InterventionTrial in Subjects With Overweight or Obesity in Primary Health Care
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
1 active site
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
November 24, 2019
CompletedFirst Posted
Study publicly available on registry
December 3, 2019
CompletedStudy Start
First participant enrolled
December 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
November 25, 2024
November 1, 2024
5.7 years
November 24, 2019
November 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change of weight between intervention group and placebo
Weight in kg measured at visits
From baseline and 12 weeks
Change of weight between intervention group and placebo
Weight in kg measured at visits
From baseline and 1 year
Change of weight between intervention group and placebo
Weight in kg measured at visits
From baseline and 2 year
Secondary Outcomes (12)
Gender differences in weight loss results
From baseline to 12 weeks
Gender differences in weight loss results
From baseline to 1 year
Gender differences in weight loss results
From baseline to 2 year
Age differences in weight loss results
From baseline to 12 weeks
Age differences in weight loss results
From baseline to 1 years
- +7 more secondary outcomes
Study Arms (2)
A-LEVAmetoden by Bertz et al
ACTIVE COMPARATORIndividual 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 COMPARATORDietary 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.
Interventions
Ordinary treatment
Eligibility Criteria
You may qualify if:
- BMI 27 ≤ 35
- age 18-75 år
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Västra Götalandsregionen
Gothenburg, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Else Johansson
Västra Götalandsregionen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2019
First Posted
December 3, 2019
Study Start
December 2, 2020
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2027
Last Updated
November 25, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share