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The sponsor requested an early termination of the study following insufficient engagement of subjects beyond 12 months of follow-up (initial follow-up was 18 months).
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| Name | Class |
|---|---|
| Luxomed | UNKNOWN |
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The study aim is to Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary care | Active Comparator | Treatment is composed of a dietary care (with advices on physical activity) given by a professional (dietician of the Nutrition Department of the Institut Pasteur de Lille). |
|
| IR reflexotherapy + dietary care | Experimental | Treatment is composed of :
|
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| IR Reflexotherapy | Experimental | Treatment is composed of IR reflexotherapy sessions given by a trained professional. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IR Reflexotherapy | Device | 18 IR reflexotherapy sessions :
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| Measure | Description | Time Frame |
|---|---|---|
| Weight changes after 12 months compared to a dietary care (associated with physical activity advice) dispensed by a professional. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of infrared (IR) reflexotherapy on weight changes. | 3, 12 and 18 months | |
| Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the weight changes. | 3, 12 and 18 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel LECERF, MD | Institut Pasteur de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NutrInvest - Institut Pasteur de Lille | Lille | Nord | 59019 | France |
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| Dietary care | Behavioral | Dietary consultation 1, 2, 3, 6, 9, 12, 15 and 18 months after the beginning of the study |
|
| Effect of infrared (IR) reflexotherapy on waist size. | 3, 12 and 18 months |
| Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the waist siez. | 3, 12 and 18 months. |
| Effect of infrared (IR) reflexotherapy on dietary habits. | 3, 12 and 18 months |
| Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on dietary habits. | 3, 12 and 18 months. |
| Effect of infrared (IR) reflexotherapy on life's quality (anxiety, depression, physical impact, psychosocial, impact on sexual life, eating well-being, feeling about the dietary care). | 3, 12 and 18 months |
| Effect of IR reflexotherapy combined with dietary care (and physical activity advises) dispensed by professional on life quality (anxiety, depression, physical impact, psychosocial, impact on sexual life, eating wellbeing, feeling about the dietary care) | 3, 12 and 18 months. |
| Effect of infrared (IR) reflexotherapy on the salivary cortisol. | 3 months |
| Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the salivary cortisol. | 3 months. |
| Effect of infrared (IR) reflexotherapy on blood pressure and heart rate. | 3 months |
| Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on blood pressure and heart rate. | 3 months. |