Randomized Study of a Simple Weight Loss Program for Obes... | NCT00131547

Studies
Randomized Study of a Simple Weight Loss Program for Obese Patients With Obstructive Sleep Apnea

NCT00131547

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Completed

Last Update Posted

Oct 16, 2008Estimated

Enrollment

56Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

Dietary Counseling

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
10596

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Aug 17, 2005

First Submission Date that Met QC Criteria

Aug 17, 2005

First Posted Date

Aug 18, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2008

Last Update Posted Date

Oct 16, 2008Estimated

Name	Class
Ontario Lung Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring.

Detailed Description

Primary Objective

To determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate OSA when compared to usual care.
To determine if the amount of weight loss achieved in a 6 month period result in improvements in objective measures of sleep disordered breathing (AHI).

Secondary Objective

To determine if the weight loss achieved in 6 months result in improvements in OSA symptoms (e.g., snoring, sleepiness) and quality of life.
To determine if metabolic parameters (e.g., lipids, glucose) improve.
To determine if there is improvement in sleep structure and oxygenation during sleep.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	Usual Clinical Care
2	Experimental	Behavioral (e.g., Counseling)	Behavioral: Dietary Counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary Counseling	Behavioral	Dietary Counseling, use of a food diary and pedometer	2

Measure	Description	Time Frame
Post treatment weight (kg)		6 months

Measure	Description	Time Frame
Change in snoring (Visual analogue scale)		6 months
Quality of life (FOSQ)		6 months
Excessive daytime sleepiness (ESS)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have undergone a sleep study at the London Health Sciences Centre or St. Thomas Elgin General Hospital Sleep Laboratory and who are newly diagnosed with obstructive sleep apnea
Patients with an age over 18 years
Patients who have an apnea-hypopnea index (AHI) of 5-40 per hour (mild-to-moderate OSA)
Patients who have an elevated body mass index (BMI) of 28 to 39 kg/m2
Patients who have an Epworth Sleepiness Scale score ≤11

Exclusion Criteria:

Patients will not be recruited:

if they are on weight loss medications
if they have seen a registered dietician in the preceding 6 months for dietary counseling
if they have attended a weight loss program in the last 6 months
if they have a history of a car accident related to sleepiness or report sleepiness when driving
if they work in a safety critical occupation and require treatment for work reasons
if they have serious or unstable cardiac co-morbidity
if they are unable or unwilling to provide informed consent
if they are pregnant
if they are unwilling to return for follow-up visits

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kathleen Ferguson, MD	Western University, Canada	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Centre		London	Ontario	N6A 4G5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D009765	Obesity

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015596	Nutrition Assessment

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided