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

NCT ID: NCT02000037

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-18
• Study Completion Date: 2016-01-28

Brief Summary

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

Conditions

Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Dietary care

Intervention Type: BEHAVIORAL

Dietary consultation 1, 2, 3, 6, 9, 12, 15 and 18 months after the beginning of the study

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).

Group Type: EXPERIMENTAL

IR Reflexotherapy

Intervention Type: DEVICE

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

Dietary care

Intervention Type: BEHAVIORAL

Dietary consultation 1, 2, 3, 6, 9, 12, 15 and 18 months after the beginning of the study

IR Reflexotherapy

Treatment is composed of IR reflexotherapy sessions given by a trained professional.

Group Type: EXPERIMENTAL

IR Reflexotherapy

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Dietary care

Dietary consultation 1, 2, 3, 6, 9, 12, 15 and 18 months after the beginning of the study

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Luxomed

UNKNOWN

Sponsor Role: collaborator

Institut Pasteur de Lille

OTHER

Sponsor Role: lead

Responsible Party

Jean-Michel Lecerf

Medical doctor specialized in endocrinology and metabolic diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Michel LECERF, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de Lille

Locations

NutrInvest - Institut Pasteur de Lille

Lille, Nord, France

Countries

France

Other Identifiers

2013-A00800-45

Identifier Type: -

Identifier Source: org_study_id