Clinical trial NCT02000037: Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People
Official title: Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
Collaborators: name: Luxomed
First posted: 2013-12-03
Enrollment: 87
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aim is to Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People.


Eligibility criteria: 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

Primary outcomes:
measure: Weight changes after 12 months compared to a dietary care (associated with physical activity advice) dispensed by a professional.
timeFrame: 12 months
Secondary outcomes:
measure: Effect of infrared (IR) reflexotherapy on weight changes.
timeFrame: 3, 12 and 18 months
measure: Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the weight changes.
timeFrame: 3, 12 and 18 months.
measure: Effect of infrared (IR) reflexotherapy on waist size.
timeFrame: 3, 12 and 18 months
measure: Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the waist siez.
timeFrame: 3, 12 and 18 months.
measure: Effect of infrared (IR) reflexotherapy on dietary habits.
timeFrame: 3, 12 and 18 months
measure: Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on dietary habits.
timeFrame: 3, 12 and 18 months.
measure: 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).
timeFrame: 3, 12 and 18 months
measure: 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)
timeFrame: 3, 12 and 18 months.
measure: Effect of infrared (IR) reflexotherapy on the salivary cortisol.
timeFrame: 3 months
measure: Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the salivary cortisol.
timeFrame: 3 months.
measure: Effect of infrared (IR) reflexotherapy on blood pressure and heart rate.
timeFrame: 3 months
measure: Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on blood pressure and heart rate.
timeFrame: 3 months.
Other outcomes:
Locations:
city: Lille
country: France
facility: NutrInvest - Institut Pasteur de Lille
state: Nord
Study officials:
affiliation: Institut Pasteur de Lille
name: Jean-Michel LECERF, MD
role: PRINCIPAL_INVESTIGATOR
References: