Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04184479

Effect of the LEVAmethod by Bertz et al © 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Overweight and Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LEVAmethod by Bertz et al

Behavioral

Ordinary treatment

Other names: Ordinary treatment

Primary outcomes

  1. Change of weight between intervention group and placebo

    Time frame: From baseline and 12 weeks

    Weight in kg measured at visits

  2. Change of weight between intervention group and placebo

    Time frame: From baseline and 1 year

    Weight in kg measured at visits

  3. Change of weight between intervention group and placebo

    Time frame: From baseline and 2 year

    Weight in kg measured at visits

Secondary outcomes

  1. Gender differences in weight loss results

    Time frame: From baseline to 12 weeks

    weight in kg measured at visits in relation to gender

  2. Gender differences in weight loss results

    Time frame: From baseline to 1 year

    weight in kg measured at visits in relation to gender

  3. Gender differences in weight loss results

    Time frame: From baseline to 2 year

    weight in kg measured at visits in relation to gender

  4. Age differences in weight loss results

    Time frame: From baseline to 12 weeks

    Weight in kg measured at visits in relation to age

  5. Age differences in weight loss results

    Time frame: From baseline to 1 years

    Weight in kg measured at visits in relation to age

  6. Age differences in weight loss results

    Time frame: From baseline to 2 years

    Weight in kg measured at visits in relation to age

  7. Weight loss result in relation to pre-treatment BMI

    Time frame: From baseline to 12 weeks

    Weight in kg measured at visits in relation to pre-treatment BMI

  8. Weight loss result in relation to pre-treatment BMI

    Time frame: From baseline to 1 year

    Weight in kg measured at visits in relation to pre-treatment BMI

  9. Weight loss result in relation to pre-treatment BMI

    Time frame: From baseline to 2 year

    Weight in kg measured at visits in relation to pre-treatment BMI

  10. Cost-effectiveness of LEVA method by Bertz et al

    Time frame: From baseline to 12 weeks

    Calculation of cost-effectiveness by the method of monetary net benefit

  11. Cost-effectiveness of LEVA method by Bertz et al

    Time frame: From baseline to 1 year

    Calculation of cost-effectiveness by the method of monetary net benefit

  12. Cost-effectiveness of LEVA method by Bertz et al

    Time frame: From baseline to 2 year

    Calculation of cost-effectiveness by the method of monetary net benefit

Study contacts

Contact information is provided by the study sponsor or research team.

Else Johansson

CONTACT

[email protected]

+46768871219

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Acronym: LEVA-POP

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Dec 3, 2019
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.