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

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IR Reflexotherapy
Dietary care
Sponsored by
Institut Pasteur de Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NutrInvest - Institut Pasteur de Lille

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Dietary care

IR reflexotherapy + dietary care

IR Reflexotherapy

Arm Description

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).

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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect of infrared (IR) reflexotherapy on weight changes.
Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the weight changes.
Effect of infrared (IR) reflexotherapy on waist size.
Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the waist siez.
Effect of infrared (IR) reflexotherapy on dietary habits.
Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on dietary habits.
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).
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)
Effect of infrared (IR) reflexotherapy on the salivary cortisol.
Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the salivary cortisol.
Effect of infrared (IR) reflexotherapy on blood pressure and heart rate.
Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on blood pressure and heart rate.

Full Information

First Posted
November 26, 2013
Last Updated
December 6, 2022
Sponsor
Institut Pasteur de Lille
Collaborators
Luxomed
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1. Study Identification

Unique Protocol Identification Number
NCT02000037
Brief Title
Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People
Acronym
REFLEX-IR
Official Title
Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
The sponsor requested an early termination of the study following insufficient engagement of subjects beyond 12 months of follow-up (initial follow-up was 18 months).
Study Start Date
October 18, 2013 (Actual)
Primary Completion Date
January 28, 2016 (Actual)
Study Completion Date
January 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Pasteur de Lille
Collaborators
Luxomed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary care
Arm Type
Active Comparator
Arm Description
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).
Arm Title
IR reflexotherapy + dietary care
Arm Type
Experimental
Arm Description
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).
Arm Title
IR Reflexotherapy
Arm Type
Experimental
Arm Description
Treatment is composed of IR reflexotherapy sessions given by a trained professional.
Intervention Type
Device
Intervention Name(s)
IR Reflexotherapy
Intervention Description
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
Behavioral
Intervention Name(s)
Dietary care
Intervention Description
Dietary consultation 1, 2, 3, 6, 9, 12, 15 and 18 months after the beginning of the study
Primary Outcome Measure Information:
Title
Weight changes after 12 months compared to a dietary care (associated with physical activity advice) dispensed by a professional.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Effect of infrared (IR) reflexotherapy on weight changes.
Time Frame
3, 12 and 18 months
Title
Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the weight changes.
Time Frame
3, 12 and 18 months.
Title
Effect of infrared (IR) reflexotherapy on waist size.
Time Frame
3, 12 and 18 months
Title
Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the waist siez.
Time Frame
3, 12 and 18 months.
Title
Effect of infrared (IR) reflexotherapy on dietary habits.
Time Frame
3, 12 and 18 months
Title
Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on dietary habits.
Time Frame
3, 12 and 18 months.
Title
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).
Time Frame
3, 12 and 18 months
Title
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)
Time Frame
3, 12 and 18 months.
Title
Effect of infrared (IR) reflexotherapy on the salivary cortisol.
Time Frame
3 months
Title
Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the salivary cortisol.
Time Frame
3 months.
Title
Effect of infrared (IR) reflexotherapy on blood pressure and heart rate.
Time Frame
3 months
Title
Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on blood pressure and heart rate.
Time Frame
3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel LECERF, MD
Organizational Affiliation
Institut Pasteur de Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
NutrInvest - Institut Pasteur de Lille
City
Lille
State/Province
Nord
ZIP/Postal Code
59019
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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