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

NCT ID: NCT04184479

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-02

Study Completion Date

2027-08-31

Brief Summary

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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

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

LEVAmethod by Bertz et al

Intervention Type BEHAVIORAL

Ordinary treatment

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.

Group Type PLACEBO_COMPARATOR

LEVAmethod by Bertz et al

Intervention Type BEHAVIORAL

Ordinary treatment

Interventions

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LEVAmethod by Bertz et al

Ordinary treatment

Intervention Type BEHAVIORAL

Other Intervention Names

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Ordinary treatment

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Else Johansson

Role: PRINCIPAL_INVESTIGATOR

Västra Götalandsregionen

Locations

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Västra Götalandsregionen

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Else Johansson

Role: CONTACT

+46768871219

Facility Contacts

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Else Johansson

Role: primary

+46768871219

Other Identifiers

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LEVA-POP

Identifier Type: -

Identifier Source: org_study_id

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