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

December 6, 2022 updated by: Jean-Michel Lecerf, Institut Pasteur de Lille
The study aim is to Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Weight changes after 12 months compared to a dietary care (associated with physical activity advice) dispensed by a professional.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Effect of infrared (IR) reflexotherapy on weight changes.
Time Frame: 3, 12 and 18 months
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.
Time Frame: 3, 12 and 18 months.
3, 12 and 18 months.
Effect of infrared (IR) reflexotherapy on waist size.
Time Frame: 3, 12 and 18 months
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.
Time Frame: 3, 12 and 18 months.
3, 12 and 18 months.
Effect of infrared (IR) reflexotherapy on dietary habits.
Time Frame: 3, 12 and 18 months
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.
Time Frame: 3, 12 and 18 months.
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).
Time Frame: 3, 12 and 18 months
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)
Time Frame: 3, 12 and 18 months.
3, 12 and 18 months.
Effect of infrared (IR) reflexotherapy on the salivary cortisol.
Time Frame: 3 months
3 months
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.
3 months.
Effect of infrared (IR) reflexotherapy on blood pressure and heart rate.
Time Frame: 3 months
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.
Time Frame: 3 months.
3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Pasteur de Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Luxomed

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Michel LECERF, MD, Institut Pasteur de Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-A00800-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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