## Protocol Section
### Identification Module
**NCT ID:** NCT04184479

**Acronym:** LEVA-POP

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

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

#### Organization Study ID Info
**ID:** LEVA-POP
#### Organization
**Class:** OTHER_GOV
**Full Name:** Vastra Gotaland Region
### Status Module
#### Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-12-02

**Type:** ACTUAL

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2019-12-03
**Type:** ACTUAL
**Study First Submit Date:** 2019-11-24
**Study First Submit QC Date:** 2019-11-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Vastra Gotaland Region

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Overweight and Obesity

**Keywords:**

- overweight

- randomized controlled trial

- obesity

- weight loss

- weight loss maintenance

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Behavioral: LEVAmethod by Bertz et al

**Label:** A-LEVAmetoden by Bertz et al

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**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 Names:**

- Behavioral: LEVAmethod by Bertz et al

**Label:** B-Ordinary treatment

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A-LEVAmetoden by Bertz et al

- B-Ordinary treatment

**Description:** Ordinary treatment

**Name:** LEVAmethod by Bertz et al

**Other Names:**

- Ordinary treatment

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Weight in kg measured at visits

**Measure:** Change of weight between intervention group and placebo

**Time Frame:** From baseline and 12 weeks

**Description:** Weight in kg measured at visits

**Measure:** Change of weight between intervention group and placebo

**Time Frame:** From baseline and 1 year

**Description:** Weight in kg measured at visits

**Measure:** Change of weight between intervention group and placebo

**Time Frame:** From baseline and 2 year

#### Secondary Outcomes

**Description:** weight in kg measured at visits in relation to gender

**Measure:** Gender differences in weight loss results

**Time Frame:** From baseline to 12 weeks

**Description:** weight in kg measured at visits in relation to gender

**Measure:** Gender differences in weight loss results

**Time Frame:** From baseline to 1 year

**Description:** weight in kg measured at visits in relation to gender

**Measure:** Gender differences in weight loss results

**Time Frame:** From baseline to 2 year

**Description:** Weight in kg measured at visits in relation to age

**Measure:** Age differences in weight loss results

**Time Frame:** From baseline to 12 weeks

**Description:** Weight in kg measured at visits in relation to age

**Measure:** Age differences in weight loss results

**Time Frame:** From baseline to 1 years

**Description:** Weight in kg measured at visits in relation to age

**Measure:** Age differences in weight loss results

**Time Frame:** From baseline to 2 years

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

**Measure:** Weight loss result in relation to pre-treatment BMI

**Time Frame:** From baseline to 12 weeks

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

**Measure:** Weight loss result in relation to pre-treatment BMI

**Time Frame:** From baseline to 1 year

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

**Measure:** Weight loss result in relation to pre-treatment BMI

**Time Frame:** From baseline to 2 year

**Description:** Calculation of cost-effectiveness by the method of monetary net benefit

**Measure:** Cost-effectiveness of LEVA method by Bertz et al

**Time Frame:** From baseline to 12 weeks

**Description:** Calculation of cost-effectiveness by the method of monetary net benefit

**Measure:** Cost-effectiveness of LEVA method by Bertz et al

**Time Frame:** From baseline to 1 year

**Description:** Calculation of cost-effectiveness by the method of monetary net benefit

**Measure:** Cost-effectiveness of LEVA method by Bertz et al

**Time Frame:** From baseline to 2 year

### Eligibility Module

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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** else.hellebo.johansson@vgregion.se

**Name:** Else Johansson

**Phone:** +46768871219

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Göteborg

**Contacts:**

***Contact 1:***

- **Email:** else.hellebo.johansson@vgregion.se

- **Name:** Else Johansson

- **Phone:** +46768871219

- **Role:** CONTACT

**Country:** Sweden

**Facility:** Västra Götalandsregionen

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Västra Götalandsregionen

**Name:** Else Johansson

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M18102

- Name: Weight Loss

- Relevance: LOW

- As Found: Unknown

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

- ID: D000050177

- Term: Overweight

### Misc Info Module

- Version Holder: 2024-05-24
