Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People
Conditions
Brief summary
The study aim is to Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People.
Interventions
DEVICEIR Reflexotherapy
18 IR reflexotherapy sessions : * Once a week for 12 weeks at the beginning of the study * Once a week for 3 weeks, 9 months after the beginning of the study * Once a week for 3 weeks, 15 months after the beginning of the study
BEHAVIORALDietary care
Dietary consultation 1, 2, 3, 6, 9, 12, 15 and 18 months after the beginning of the study
Sponsors
Luxomed
Institut Pasteur de Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI between 27 and 35 kg/m2 (included), * Aged 30 to 60 years old (included), * Stable weight: no variation of 3 kg in the las 3 months, * Signed the consent form, * Able to follow the study, * Health insured.
Exclusion criteria
* History of coronary disease (in the last 6 months), * Progressive illness at the time of the study (cancer, neurodegenerative disease...), * Diabetics (treated or not), * Fasting blood total cholesterol equal or over 2.5 g/L (treated or not), * Fasting blood triglycerides equal or over 2.0 g/L (treated or not), * Fasting blood glucose equal or over 1.26 g/L, * Peripheral neuropathy (polyneuritis, diabetic neuropathy) or central neuropathy (hemiplegia), * Infectious cutaneous condition or allergies (to the contact point of the device), * History of stroke, * Severe heart disease, * Epilepsy, * Reduced motility, * Diagnosed eating disorder, * Followed a diet in the last 90 days in order to lose weight, * Took weight loss assistance drug (Orlistat) in the last month or is likely to take one during the study, * Psychiatric disorder incompatible with the study, * Mental illness, * Neurological disorder, * Chronic somatic disease, * Addiction or nicotine withdrawal, * Under psychoactive drug , * Alcool consumption over 3 glasses a day, * Pregnant or breastfeeding women, * Women that are likely to get pregnant during the study, * Is unable to understand or follow the protocol * Is deprived of liberty * Is under judicial protection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight changes after 12 months compared to a dietary care (associated with physical activity advice) dispensed by a professional. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
| 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 weight changes. | 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. |
| 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 |
Countries
France
Outcome results
None listed