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

Not Applicable

Recruiting

• Conditions: Overweight and Obesity
• Interventions: Behavioral: LEVAmethod by Bertz et al

• Registration Number: NCT04184479
• Lead Sponsor: Vastra Gotaland Region

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.

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 Timeline

• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-28
• Study First Posted: 2019-12-03
• Study Start: 2020-12-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B-Ordinary treatment	LEVAmethod by Bertz et al	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.
A-LEVAmetoden by Bertz et al	LEVAmethod by Bertz et al	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.

Primary Outcome Measures

Name	Time	Method
Change of weight between intervention group and placebo	From baseline and 2 year	Weight in kg measured at visits

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness of LEVA method by Bertz et al	From baseline to 2 year	Calculation of cost-effectiveness by the method of monetary net benefit
Gender differences in weight loss results	From baseline to 2 year	weight in kg measured at visits in relation to gender
Age differences in weight loss results	From baseline to 2 years	Weight in kg measured at visits in relation to age
Weight loss result in relation to pre-treatment BMI	From baseline to 2 year	Weight in kg measured at visits in relation to pre-treatment BMI

Trial Locations

Locations (1)

Västra Götalandsregionen; 🇸🇪 Göteborg, Sweden