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Effect of the LEVAmethod by Bertz et al © in Subjects With Overweight or Obesity in Primary Health Care. (LEVA-POP)

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
LEVAmethod by Bertz et al
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring overweight, randomized controlled trial, obesity, weight loss, weight loss maintenance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Närhälsan Dietistenhet at wrong premises and the patient should be treated elsewhere.

Sites / Locations

  • Västra GötalandsregionenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A-LEVAmetoden by Bertz et al

B-Ordinary treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of weight between intervention group and placebo
Weight in kg measured at visits
Change of weight between intervention group and placebo
Weight in kg measured at visits
Change of weight between intervention group and placebo
Weight in kg measured at visits

Secondary Outcome Measures

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

Full Information

First Posted
November 24, 2019
Last Updated
November 5, 2021
Sponsor
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT04184479
Brief Title
Effect of the LEVAmethod by Bertz et al © in Subjects With Overweight or Obesity in Primary Health Care.
Acronym
LEVA-POP
Official Title
Placebo-Controlled, Randomized Weight Loss InterventionTrial in Subjects With Overweight or Obesity in Primary Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 Närhälsan 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
overweight, randomized controlled trial, obesity, weight loss, weight loss maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A-LEVAmetoden by Bertz et al
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B-Ordinary treatment
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LEVAmethod by Bertz et al
Other Intervention Name(s)
Ordinary treatment
Intervention Description
Ordinary treatment
Primary Outcome Measure Information:
Title
Change of weight between intervention group and placebo
Description
Weight in kg measured at visits
Time Frame
From baseline and 12 weeks
Title
Change of weight between intervention group and placebo
Description
Weight in kg measured at visits
Time Frame
From baseline and 1 year
Title
Change of weight between intervention group and placebo
Description
Weight in kg measured at visits
Time Frame
From baseline and 2 year
Secondary Outcome Measure Information:
Title
Gender differences in weight loss results
Description
weight in kg measured at visits in relation to gender
Time Frame
From baseline to 12 weeks
Title
Gender differences in weight loss results
Description
weight in kg measured at visits in relation to gender
Time Frame
From baseline to 1 year
Title
Gender differences in weight loss results
Description
weight in kg measured at visits in relation to gender
Time Frame
From baseline to 2 year
Title
Age differences in weight loss results
Description
Weight in kg measured at visits in relation to age
Time Frame
From baseline to 12 weeks
Title
Age differences in weight loss results
Description
Weight in kg measured at visits in relation to age
Time Frame
From baseline to 1 years
Title
Age differences in weight loss results
Description
Weight in kg measured at visits in relation to age
Time Frame
From baseline to 2 years
Title
Weight loss result in relation to pre-treatment BMI
Description
Weight in kg measured at visits in relation to pre-treatment BMI
Time Frame
From baseline to 12 weeks
Title
Weight loss result in relation to pre-treatment BMI
Description
Weight in kg measured at visits in relation to pre-treatment BMI
Time Frame
From baseline to 1 year
Title
Weight loss result in relation to pre-treatment BMI
Description
Weight in kg measured at visits in relation to pre-treatment BMI
Time Frame
From baseline to 2 year
Title
Cost-effectiveness of LEVA method by Bertz et al
Description
Calculation of cost-effectiveness by the method of monetary net benefit
Time Frame
From baseline to 12 weeks
Title
Cost-effectiveness of LEVA method by Bertz et al
Description
Calculation of cost-effectiveness by the method of monetary net benefit
Time Frame
From baseline to 1 year
Title
Cost-effectiveness of LEVA method by Bertz et al
Description
Calculation of cost-effectiveness by the method of monetary net benefit
Time Frame
From baseline to 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 Närhälsan Dietistenhet at wrong premises and the patient should be treated elsewhere.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Else Johansson
Phone
+46768871219
Email
else.hellebo.johansson@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Else Johansson
Organizational Affiliation
Västra Götalandsregionen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Västra Götalandsregionen
City
Göteborg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Else Johansson
Phone
+46768871219
Email
else.hellebo.johansson@vgregion.se

12. IPD Sharing Statement

Plan to Share IPD
No

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

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