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

NCT02000037 | Terminated

• 1 other identifier: 2013-A00800-45
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (12)

• Effect of infrared (IR) reflexotherapy on weight changes.

  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.

  3, 12 and 18 months.

• Effect of infrared (IR) reflexotherapy on waist size.

  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.

  3, 12 and 18 months.

• Effect of infrared (IR) reflexotherapy on dietary habits.

  3, 12 and 18 months

Study Arms (3)

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).

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).

Device: IR Reflexotherapy; Behavioral: Dietary care

IR Reflexotherapy

EXPERIMENTAL

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

Device: IR Reflexotherapy

Interventions

IR Reflexotherapy 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

IR Reflexotherapy; IR reflexotherapy + dietary care

Dietary care BEHAVIORAL

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

Dietary care; IR reflexotherapy + dietary care

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Institut Pasteur de Lille: lead
• Luxomed: collaborator

Study Sites (1)

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

Location

Study Officials

• Jean-Michel LECERF, MD

  Institut Pasteur de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor specialized in endocrinology and metabolic diseases

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: October 18, 2013
• Primary Completion: January 28, 2016
• Study Completion: January 28, 2016
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

FR (1)