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

Study Overview
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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 Närhälsan 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.

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: LEVAmethod by Bertz et al


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A-LEVAmetoden by Bertz et al<br>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. | Behavioral: LEVAmethod by Bertz et al<br>* Ordinary treatment<br>* Other names: Ordinary treatment;|
| Placebo Comparator: B-Ordinary treatment<br>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. | Behavioral: LEVAmethod by Bertz et al<br>* Ordinary treatment<br>* Other names: Ordinary treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of weight between intervention group and placebo | Weight in kg measured at visits | From baseline and 12 weeks | 
| Change of weight between intervention group and placebo | Weight in kg measured at visits | From baseline and 1 year | 
| Change of weight between intervention group and placebo | Weight in kg measured at visits | From baseline and 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gender differences in weight loss results | weight in kg measured at visits in relation to gender | From baseline to 12 weeks | 
| Gender differences in weight loss results | weight in kg measured at visits in relation to gender | From baseline to 1 year | 
| Gender differences in weight loss results | weight in kg measured at visits in relation to gender | From baseline to 2 year | 
| Age differences in weight loss results | Weight in kg measured at visits in relation to age | From baseline to 12 weeks | 
| Age differences in weight loss results | Weight in kg measured at visits in relation to age | From baseline to 1 years | 
| Age differences in weight loss results | Weight in kg measured at visits in relation to age | From baseline to 2 years | 
| Weight loss result in relation to pre-treatment BMI | Weight in kg measured at visits in relation to pre-treatment BMI | From baseline to 12 weeks | 
| Weight loss result in relation to pre-treatment BMI | Weight in kg measured at visits in relation to pre-treatment BMI | From baseline to 1 year | 
| Weight loss result in relation to pre-treatment BMI | Weight in kg measured at visits in relation to pre-treatment BMI | From baseline to 2 year | 
| Cost-effectiveness of LEVA method by Bertz et al | Calculation of cost-effectiveness by the method of monetary net benefit | From baseline to 12 weeks | 
| Cost-effectiveness of LEVA method by Bertz et al | Calculation of cost-effectiveness by the method of monetary net benefit | From baseline to 1 year | 
| Cost-effectiveness of LEVA method by Bertz et al | Calculation of cost-effectiveness by the method of monetary net benefit | From baseline to 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, randomized controlled trial, obesity, weight loss, weight loss maintenance