Clinical trial NCT04184479: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: overweight
randomized controlled trial
obesity
weight loss
weight loss maintenance
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2019-12-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of weight between intervention group and placebo
timeFrame: From baseline and 12 weeks
measure: Change of weight between intervention group and placebo
timeFrame: From baseline and 1 year
measure: Change of weight between intervention group and placebo
timeFrame: From baseline and 2 year
Secondary outcomes:
measure: Gender differences in weight loss results
timeFrame: From baseline to 12 weeks
measure: Gender differences in weight loss results
timeFrame: From baseline to 1 year
measure: Gender differences in weight loss results
timeFrame: From baseline to 2 year
measure: Age differences in weight loss results
timeFrame: From baseline to 12 weeks
measure: Age differences in weight loss results
timeFrame: From baseline to 1 years
measure: Age differences in weight loss results
timeFrame: From baseline to 2 years
measure: Weight loss result in relation to pre-treatment BMI
timeFrame: From baseline to 12 weeks
measure: Weight loss result in relation to pre-treatment BMI
timeFrame: From baseline to 1 year
measure: Weight loss result in relation to pre-treatment BMI
timeFrame: From baseline to 2 year
measure: Cost-effectiveness of LEVA method by Bertz et al
timeFrame: From baseline to 12 weeks
measure: Cost-effectiveness of LEVA method by Bertz et al
timeFrame: From baseline to 1 year
measure: Cost-effectiveness of LEVA method by Bertz et al
timeFrame: From baseline to 2 year
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Västra Götalandsregionen
Study officials:
affiliation: Västra Götalandsregionen
name: Else Johansson
role: PRINCIPAL_INVESTIGATOR
References: