Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People (REFLEX-IR)

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

Study Overview

• Status: Terminated
• Conditions: Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People
• Intervention / Treatment: Behavioral: Dietary care; Device: IR Reflexotherapy

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nord
    • Lille, Nord, France, 59019
      • NutrInvest - Institut Pasteur de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dietary care; 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).	Behavioral: Dietary care; Dietary consultation 1, 2, 3, 6, 9, 12, 15 and 18 months after the beginning of the study
Experimental: IR reflexotherapy + dietary care; Treatment is composed of : IR reflexotherapy sessions given by a trained professional ;; dietary care (with advices on physical activity) given by a professional (dietician of the Nutrition Department of the Institut Pasteur de Lille).	Behavioral: Dietary care; Dietary consultation 1, 2, 3, 6, 9, 12, 15 and 18 months after the beginning of the study; Device: IR 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
Experimental: IR Reflexotherapy; Treatment is composed of IR reflexotherapy sessions given by a trained professional.	Device: IR 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Institut Pasteur de Lille
• Collaborators: Luxomed
• Investigators: Principal Investigator: Jean-Michel LECERF, MD, Institut Pasteur de Lille

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2013
• Primary Completion (Actual): January 28, 2016
• Study Completion (Actual): January 28, 2016

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 2013-A00800-45