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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-LEVAmetoden by Bertz et al | Active Comparator | 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. |
|
| B-Ordinary treatment | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEVAmethod by Bertz et al | Behavioral | Ordinary treatment |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Else Johansson | Contact | +46768871219 | else.hellebo.johansson@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Else Johansson | Västra Götalandsregionen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Västra Götalandsregionen | Recruiting | Gothenburg | Sweden |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |