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

Vastra Gotaland Region

Status: Enrolling

Conditions: Overweight and Obesity

Treatments: Behavioral: LEVAmethod by Bertz et al

Study type: Interventional

Funder types: Other

Identifiers

NCT04184479

LEVA-POP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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 Primärvårdens Dietistenhet at wrong premises and the patient should be treated elsewhere.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

A-LEVAmetoden by Bertz et al

Active Comparator group

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.

Treatment:

Behavioral: LEVAmethod by Bertz et al

B-Ordinary treatment

Placebo Comparator group

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.

Treatment:

Behavioral: LEVAmethod by Bertz et al