Effect of the LEVAmethod by Bertz et al © in Subjects With Overweight or Obesity in Primary Health Care.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LEVAmethod by Bertz et al.
- Who it may be relevant to
- Registry conditions: Overweight and Obesity. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Placebo-Controlled, Randomized Weight Loss InterventionTrial in Subjects With Overweight or Obesity in Primary Health Care
Overview
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.
Interventions
- Behavioral LEVAmethod by Bertz et al
Ordinary treatment
Primary outcome measures
- Change of weight between intervention group and placebo [Time frame: From baseline and 12 weeks]
- Change of weight between intervention group and placebo [Time frame: From baseline and 1 year]
- Change of weight between intervention group and placebo [Time frame: From baseline and 2 year]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- BMI 27 ≤ 35
- age 18-75 år
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Västra Götalandsregionen — Gothenburg
Identifiers
NCT: NCT04184479 · LEVA-POP