Cost-effectiveness Study of a Lifestyle Change Program for the Treatment of OSA and Obesity: Hospital-Primary Care.

Summary

Obesity is the main risk factor for Obstructive Sleep Apnea (OSA). Nasal CPAP is the standard treatment for OSA, but since weight-loss programs are not usually offered to OSA patients, the root causes of their illness and its comorbidities are not treated. There is some evidence regarding improvements in OSA after weight reduction but whether weight reduction programs are cost-efficient has not as yet been addressed. OBJECTIVE: To determine whether an intensive weight-loss program, carried out in a project combining hospital and primary care levels, is cost-effective in the medium and long term for the treatment of obese patients with severe OSA undergoing CPAP treatment. More concretely, our objective is to demonstrate whether this program achieves sufficient improvement in OSA to allow a reduction \<30/h in the apnea-hypopnea index in at least 25%, improving their metabolic profile and central obesity. METHOD: A prospective, randomized, controlled study. Control group: standard dietary recommendations.

Intervention group: 0-3 months very low calorie diet, 15 days substituting three meals for low calorie shakes, from 15 to 120 days substituting 1 meal and from 120 days to 12 months on a low calorie diet while starting a progressive exercise program. Recommendations for good sleep habits will be given. The program will be carried out through group and individual sessions with the hospital dietician. After 3 months: group sessions with a nurse in the basic area. Group sessions led by hospital dietician. From 3 to 12 months: group sessions led by primary care nurse. MEASUREMENTS: At the beginning, at 3 and at 12 months: two-night home respiratory polygraph, actigraphy, anthropometric and blood analysis data including metabolic syndrome and inflammatory markers, and health related quality of life questionnaires. Direct and indirect costs of treatments, outpatient's consultations, incomes, emergency visits and patients' travel costs to medical centers.

Conditions

• Obstructive Sleep Apnea of Adult
• Obesity
• Lifestyle
• Weight Loss

Interventions

BEHAVIORAL

Intensive weigh-loss program

Intervention group: Intensive weight-loss program: 0-3 months very low calorie diet, 15 days substituting three meals for low calorie shakes, from 15 to 120 days substituting 1 meal and from 120 days to 12 months on a low calorie diet while starting a progressive exercise programme. Recommendations for good sleep habits will be given. The program will be carried out through group and individual sessions with the hospital dietician. After 3 months: group sessions with a nurse in the basic area. Group sessions led by hospital dietician. From 3 to 12 months: group sessions led by primary care nurse.

BEHAVIORAL

Standard Dietary recommendations

Patients will be managed according to the usual recommendations: The common written diet (designed by a hospital nutritionist) and an exercise advice will be given according to patient age and level of activity, without any other assessment or additional visits.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge

  lead OTHER

Principal Investigators

• Neus Salord, MD, phD · Hospital Universitari de Bellvige

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2021-01-30

Completion

2021-01-30

Countries

• Spain

Study Locations