Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese PeopleREFLEX-IRNCT02000037
Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People
A study testing IR Reflexotherapy and Dietary care in people with Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People, run by Institut Pasteur de Lille at 1 site in France.
Trial summary
The study aim is to Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People
- What is being tested?
- IR Reflexotherapy and Dietary care
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2013to 28 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The study aim is to Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People.
- Being tested
- IR Reflexotherapy, Dietary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IR ReflexotherapyDevice
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 careBehavioural
Dietary consultation 1, 2, 3, 6, 9, 12, 15 and 18 months after the beginning of the study
| Study group | Role | What they receive |
|---|---|---|
| Dietary care | Active comparator | 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). Receives: Behavioral: Dietary care |
| IR reflexotherapy + dietary care | Experimental | 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). Receives: Device: IR Reflexotherapy; Behavioral: Dietary care |
| IR Reflexotherapy | Experimental | Treatment is composed of IR reflexotherapy sessions given by a trained professional. Receives: Device: IR Reflexotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight changes after 12 months compared to a dietary care (associated with physical activity advice) dispensed by a professional.
Measured: 12 months
Secondary outcomes (12)
Effect of infrared (IR) reflexotherapy on weight changes.
Measured: 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.
Measured: 3, 12 and 18 months.
Effect of infrared (IR) reflexotherapy on waist size.
Measured: 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.
Measured: 3, 12 and 18 months.
Effect of infrared (IR) reflexotherapy on dietary habits.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 3, 12 and 18 months.
Effect of infrared (IR) reflexotherapy on the salivary cortisol.
Measured: 3 months
Effect of IR reflexotherapy combined with a dietary care (and physical activity advises) dispensed by a professional on the salivary cortisol.
Measured: 3 months.
Effect of infrared (IR) reflexotherapy on blood pressure and heart rate.
Measured: 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.
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study start18 Oct 2013
- Primary completion28 Jan 2016
- Study completion28 Jan 2016
Why it 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).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Luxomed
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Jean-Michel LECERF, MD, Principal investigator, Institut Pasteur de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000037
- Sponsor's protocol ID
- 2013-A00800-45
- Acronym
- REFLEX-IR
- Status last verified
- Dec 2022
- First submitted
- 26 Nov 2013
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People
- ClinicalTrials.gov ID
- NCT02000037
- Acronym / sponsor ID
- REFLEX-IR / 2013-A00800-45
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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).
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Collaborators
- Luxomed
- Study start
- 18 Oct 2013 (actual)
- Primary completion
- 28 Jan 2016 (actual)
- Study completion
- 28 Jan 2016 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aim is to Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary care | Active comparator | Behavioral: Dietary careTreatment 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). |
| IR reflexotherapy + dietary care | Experimental | Device: IR Reflexotherapy, Behavioral: Dietary careTreatment 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). |
| IR Reflexotherapy | Experimental | Device: IR ReflexotherapyTreatment is composed of IR reflexotherapy sessions given by a trained professional. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (27 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IR Reflexotherapy18 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 | Device | IR Reflexotherapy, IR reflexotherapy + dietary care |
| Dietary careDietary consultation 1, 2, 3, 6, 9, 12, 15 and 18 months after the beginning of the study | Behavioural | Dietary care, IR reflexotherapy + dietary care |
Primary outcome
Weight changes after 12 months compared to a dietary care (associated with physical activity advice) dispensed by a professional.
Time frame: 12 months
12 secondary outcomes
Effect of infrared (IR) reflexotherapy on weight changes.
Time frame: 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.
Effect of infrared (IR) reflexotherapy on waist size.
Time frame: 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.
Effect of infrared (IR) reflexotherapy on dietary habits.
Time frame: 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.
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
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.
Effect of infrared (IR) reflexotherapy on the salivary cortisol.
Time frame: 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.
Effect of infrared (IR) reflexotherapy on blood pressure and heart rate.
Time frame: 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.
Results and safety
The study was stopped early (reason given: 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).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel LECERF, MD principal investigator
Institut Pasteur de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IR Reflexotherapy and Dietary care in people with Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People, run by Institut Pasteur de Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight changes after 12 months compared to a dietary care (associated with physical activity advice) dispensed by a professional. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.