Effect of the LEVAmethod by Bertz et al © in Subjects With Overweight or Obesity in Primary Health Care.

Overweight and Obesity Clinical Trial

— LEVA-POP  

Official title:

Placebo-Controlled, Randomized Weight Loss InterventionTrial in Subjects With Overweight or Obesity in Primary Health Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04184479
• Other study ID #: LEVA-POP
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: August 2025

Study information

• Verified date: April 2023
• Source: Vastra Gotaland Region
• Contact: Else Johansson
• Phone: +46768871219
• Email: else.hellebo.johansson[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• LEVAmethod by Bertz et al
Ordinary treatment

Locations

Country	Name	City	State
Sweden	Västra Götalandsregionen	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of weight between intervention group and placebo	Weight in kg measured at visits	From baseline and 12 weeks
Primary	Change of weight between intervention group and placebo	Weight in kg measured at visits	From baseline and 1 year
Primary	Change of weight between intervention group and placebo	Weight in kg measured at visits	From baseline and 2 year
Secondary	Gender differences in weight loss results	weight in kg measured at visits in relation to gender	From baseline to 12 weeks
Secondary	Gender differences in weight loss results	weight in kg measured at visits in relation to gender	From baseline to 1 year
Secondary	Gender differences in weight loss results	weight in kg measured at visits in relation to gender	From baseline to 2 year
Secondary	Age differences in weight loss results	Weight in kg measured at visits in relation to age	From baseline to 12 weeks
Secondary	Age differences in weight loss results	Weight in kg measured at visits in relation to age	From baseline to 1 years
Secondary	Age differences in weight loss results	Weight in kg measured at visits in relation to age	From baseline to 2 years
Secondary	Weight loss result in relation to pre-treatment BMI	Weight in kg measured at visits in relation to pre-treatment BMI	From baseline to 12 weeks
Secondary	Weight loss result in relation to pre-treatment BMI	Weight in kg measured at visits in relation to pre-treatment BMI	From baseline to 1 year
Secondary	Weight loss result in relation to pre-treatment BMI	Weight in kg measured at visits in relation to pre-treatment BMI	From baseline to 2 year
Secondary	Cost-effectiveness of LEVA method by Bertz et al	Calculation of cost-effectiveness by the method of monetary net benefit	From baseline to 12 weeks
Secondary	Cost-effectiveness of LEVA method by Bertz et al	Calculation of cost-effectiveness by the method of monetary net benefit	From baseline to 1 year
Secondary	Cost-effectiveness of LEVA method by Bertz et al	Calculation of cost-effectiveness by the method of monetary net benefit	From baseline to 2 year