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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: LEVAmethod by Bertz et al

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Else Johansson; Phone Number: +46768871219; Email: else.hellebo.johansson@vgregion.se

Study Locations

• Sweden
  • Göteborg, Sweden
    • Recruiting
    • Västra Götalandsregionen
    • Contact: Else Johansson; Phone Number: +46768871219; Email: else.hellebo.johansson@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A-LEVAmetoden 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.	Behavioral: LEVAmethod by Bertz et al; Ordinary treatment; Other Names: Ordinary treatment
Placebo Comparator: B-Ordinary treatment; 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.	Behavioral: LEVAmethod by Bertz et al; Ordinary treatment; Other Names: Ordinary treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender differences in weight loss results	weight in kg measured at visits in relation to gender	From baseline to 12 weeks
Gender differences in weight loss results	weight in kg measured at visits in relation to gender	From baseline to 1 year
Gender differences in weight loss results	weight in kg measured at visits in relation to gender	From baseline to 2 year
Age differences in weight loss results	Weight in kg measured at visits in relation to age	From baseline to 12 weeks
Age differences in weight loss results	Weight in kg measured at visits in relation to age	From baseline to 1 years
Age differences in weight loss results	Weight in kg measured at visits in relation to age	From baseline to 2 years
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Else Johansson, Västra Götalandsregionen

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: November 24, 2019
• First Submitted That Met QC Criteria: November 28, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; obesity; overweight; weight loss; weight loss maintenance
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: LEVA-POP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No