Maâthermes: Spa Treatment for Overweight and Obesity

NCT01258114 | Completed Phase 3

• 1 other identifier: MAATHERMES
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 5

Brief Summary

Public health campaigns and industry-supported changes in our food supply have obviously failed to control the epidemic to date. However, customized life style modification programs (LSMP) comprising diet, physical activity and behavioral therapy (a set of principles designed to help patients achieve their goals) induce weight loss of 10% of baseline body weight after 16 to 26 weeks of intervention . Long-term weight control is then facilitated by an appropriate weight-loss maintenance strategy such as continued patient-therapist contact (whether provided in person or by telephone or e-mail). This strategy allows patients to stabilize at an average of 5% and 3% loss of baseline body weight after 1 and 2 years, respectively. Numerous reports have concluded that this modest weight loss contributes to important health benefits. However, the high dropout rate during weight-management strategies presumably means that treatment is mainly effective in highly motivated patients, as the highest success rates are likely to be reported among study completers. Many individuals appear to conclude that the benefits of weight-management strategies are not worth the cost (i.e. time, money, and continued unrewarding efforts). This underlines the critical need to implement new, practical and affordable strategies to induce and maintain weight loss that can be achieved by most patients. The main objective of this study is to test the hypothesis that a 3 week intensive course of spa therapy can reduce the weight (and/or BMI) of overweight or obese patient at 14 months (BMI from 27 to 35).

Conditions

Overweight; Obesity

Keywords

Overweight; Obesity; Balneotherapy; Spa Therapy; balneology; hydrotherapy; SF 12; Nutritional counselling; Zelen double consent; Lifestyle modification program; IMC

Outcome Measures

Primary Outcomes (1)

• SPA treatment (ST) : Active comparator spa treatment during 18 days soon after randomization. The Weight loss will be measured in kg and kg/m2 at 14 months

  spa treatment during 18 days soon after randomization Weight loss assessed in kg and kg/m2 at 14 months

  14 months

Secondary Outcomes (2)

• Patients achieving a weight loss of 5%

  14 months

• Quality of life : assessed by SF12

  14 months

Study Arms (2)

SPA treatment (ST)

ACTIVE COMPARATOR

Drug : spa treatment during 18 days soon after randomization the most adapted to the concerned pathology and common to all of spa resorts (mineral water drinking, bath with automatic air (bubble bathing), mud body wrapping, manual massages, water exercises) ; * nutritional counseling (french nutritional recommendations booklet) ; * caloric restriction and physical training on demand (non mandatory).

Other: SPA treatment (ST)

Non SPA treatment (NST)

SHAM COMPARATOR

Drug: General practitioner (GP) counselling After randomisation Verbal and/or written advice based on the "French national guidelines for a healthy life style" brochure (given to the patient by the GP at baseline)

Other: Non SPA treatment (NST)

Interventions

SPA treatment (ST) OTHER

Drug: spa treatment soon after randomization : Spa treatment of 18 days. Spa treatment : the most adapted to the concerned pathology and common to all of spa resorts (mineral water drinking, bath with automatic air (bubble bathing), mud body wrapping, manual massages, water exercises ; * nutritional counseling (french nutritional recommendations booklet) ; * caloric restriction and physical training on demand (non mandatory).

SPA treatment (ST)

Non SPA treatment (NST) OTHER

Drug: General practitioner (GP) counselling After randomisation Verbal and/or written advice based on the "French national guidelines for a healthy life style" brochure (given to the patient by the GP at baseline)

Non SPA treatment (NST)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sexes, more than 20 years and less than 70 years old patients with overweight (BMI\>27) or obesity (BMI\<35). Available for a spa treatment during 18 days, and a follow-up period of 14 months
• Voluntary to participate to the study,informed consent form signed after appropriate information
• Affiliation to the social security system or equivalent

You may not qualify if:

• Previous spa therapy for weight problems
• Pregnancy
• Major eating disorders (compulsive over eating)
• Poor french proficiency
• Involvement in another clinical trial
• Other contra-indications to spa therapy (severe general weakness, inflammatory bowel disease, cirrhosis, severe disability, psychosis and dementia, or Immunodeficiency, cancer in progress).
• Refusal to consent
• Refusal of spa treatment

Sponsors & Collaborators

• Association Francaise pour la Recherche Thermale: lead
• Université Joseph Fourier: collaborator
• Université Victor Segalen Bordeaux 2: collaborator
• HAT Consultant: collaborator
• AXONAL S.A.: collaborator

Study Sites (5)

Cabinet Médical

Brides-les-Bains, 73000, France

Location

Cabinet Medical

Capvern-les-Bains, 65000, France

Location

Cabinet Medical

Vals-les-Bains, 07000, France

Location

Cabinet Medical

Vichy, 03000, France

Location

Cabinet Medical

Vittel, 88000, France

Location

Related Publications (14)

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MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick SEROG, MD

  Hospital PARIS

  PRINCIPAL INVESTIGATOR

• Thierry HANH, MD

  PARIS HAT Consultant

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 10, 2010
• Study Start: March 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 10, 2010

Record last verified: 2010-12

Locations

FR (5)