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

• Sponsor: Institut Pasteur de Lille (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02000037
• Collaborator: Luxomed (Other)
• Enrollment: 87
• Location: 1
• Arms: 3
• Duration (Months): 29
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

It is known that the care that is offered to overweigh of class I obese people leads to an initial weight loss.

However, after 12 months, people start to gain their weight back. French National Authority for Health suggests that physicians warn their patients against restrictive diets that can are the origin of weight's fluctuation can be health threatening. This weight regain is linked to numerous factors, mainly dietary compensation phenomenon tied to cravings (Lecerf, 2013. Obésité : pourquoi les regimes échouent-ils ? Nutr Clin Metab (in press)).

Due to the difficulties to keep the weight loss, it seems interesting to consider alternatives like reflexotherapy. This method seems to act in reducing the dietary urges causes by stress, by cravings or by frustration.

This technique would allow to re-establish normal hormones' or neurotransmitters' concentrations mainly involved in the food intake.

This could be a complementary response to the limits of the classic treatments for weight maintenance management, but it needs to be confirmed by a specific study.

Condition or Disease	Intervention/Treatment	Phase
Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People	Device: IR Reflexotherapy; Behavioral: Dietary care	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People
• Study Start Date: Oct 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Mar 1, 2016

Arms and Interventions

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).	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; Behavioral: Dietary care; Dietary consultation 1, 2, 3, 6, 9, 12, 15 and 18 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

Outcome Measures

Primary Outcome Measures

1. Weight changes after 12 months compared to a dietary care (associated with physical activity advice) dispensed by a professional. [12 months]

Secondary Outcome Measures

1. Effect of infrared (IR) reflexotherapy on weight changes. [3, 12 and 18 months]

2. 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.]

3. Effect of infrared (IR) reflexotherapy on waist size. [3, 12 and 18 months]

4. 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.]

5. Effect of infrared (IR) reflexotherapy on dietary habits. [3, 12 and 18 months]

6. 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.]

7. 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]

8. 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.]

9. Effect of infrared (IR) reflexotherapy on the salivary cortisol. [3 months]

10. Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the salivary cortisol. [3 months.]

11. Effect of infrared (IR) reflexotherapy on blood pressure and heart rate. [3 months]

12. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NutrInvest - Institut Pasteur de Lille	Lille	Nord	France	59019

Sponsors and Collaborators

• Institut Pasteur de Lille
• Luxomed

Investigators

• Principal Investigator: Jean-Michel LECERF, MD, Institut Pasteur de Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jean-Michel Lecerf, Medical doctor specialized in endocrinology and metabolic diseases, Institut Pasteur de Lille
• ClinicalTrials.gov Identifier: NCT02000037
• Other Study ID Numbers: 2013-A00800-45
• First Posted: Dec 3, 2013
• Last Update Posted: Dec 3, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Dec 3, 2013