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Flinders Chronic Condition Self-managment Program for Weight Loss in Obstructive Sleep Apnoea study

Flinders Chronic Condition Self-managment Program for Weight Loss in Obese Adults with Obstructive Sleep Apnoea study: Scale-up study to underpin application for large- scale trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001117505
Acronym
FOSA study
Enrollment
40
Registered
2015-10-23
Start date
2015-09-29
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary study hypothesis is that use of the Flinders chronic condition self-management program (FP) intervention will result in weight loss in patients with moderate to severe obstructive sleep apnoea (OSA) over a 6 month period compared to a cohort of historical patients matched for age, sex and baseline BMI with moderate-severe OSA. INTERVENTION: The Flinders Chronic Condition Management Program will be delivered to all participants. The Flinders Program was developed by the Flinders Human Behaviour & Health Research Unit (FHBHRU) and is used widely to enable patients to self-manage their chronic disease. Patients will also be offered a weight management Impromy program developed by Commonwealth Scientific and Industrial Research Organisation (CSIRO) at no cost in addition to intensive support using behavioural techniques. The pharmacy-supervised Impromy program uses nutritious and highly accepted meal replacements as a means to weight loss. DESIGN: A prospective cohort of 40 patients will be compared to a historical control cohort. DURATION: Participants will be followed-up over a 6 month period to assist them to achieve their goals.

Interventions

The intervention will comprise of a comprehensive approach to weight loss via the Flinders Program Flinders Chronic Condition Management Program which will be delivered to all participants. The Flinders Program (FP) was developed by the FHBHRU* and is used widely to enable patients to self-manage their chronic disease. The Flinders Chronic Condition Management Program will be delivered to all participants for 6 months. Patients will also be offered a weight management Impromy program develop

The intervention will comprise of a comprehensive approach to weight loss via the Flinders Program Flinders Chronic Condition Management Program which will be delivered to all participants. The Flinders Program (FP) was developed by the FHBHRU* and is used widely to enable patients to self-manage their chronic disease. The Flinders Chronic Condition Management Program will be delivered to all participants for 6 months. Patients will also be offered a weight management Impromy program developed by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) at no cost in addition to intensive support using behavioural techniques. The pharmacy-supervised Impromy program uses nutritious and highly accepted meal replacements as a means to weight loss. Further details regarding the Flinders Program: The Flinders Program provides a framework and tools that engage the patient and structure self- management assessment and tailored planning, motivational enhancement, disease management, prevention, coordination and outcome measurement. The first step is patient completion of the Partners in Health (PIH) tool, an as- sessment of self-management, knowledge, shared decision making, symptom management, adherence to medical management, impact of condition(s) and lifestyle behaviours. The clinician then uses the Cue and Response (C&R) tool to conduct an interview with the patient on the same items. This process leads to shared decisions on issues requiring intervention. Clinician and patient then identify the patient’s main (life) problem and set a medium term (6 month) goal using the Problem and Goals tool (P&G). The output is a care plan (the Flinders Care Plan tool) documenting issues that patient and clinician agree to act on over the following 6 months. At follow up contacts, the clinician monitors outcomes of the care plan using PIH and P&G scores, helps the patient to achieve goals using motivational and problem solving approaches and uses the structured framework of the Program to manage activities. The Flinders Program encompasses relevant evidence based patient education programs and the medical and psychiatric and community services that the patient agrees to access according to their priorities, therefore tailored to each individual. The program can be delivered face to face, by phone and/or electronically to suit patient needs. Intensive support using behavioural techniques has been associated with success in weight loss programs including; providing instruction, prompting intention formation, specific goal setting, self-monitoring, review of behavioral goals and practice, feedback on performance, and relapse prevention and use of CBT and motivational interviewing. These behaviour change techniques are used within the Flinders Program therefore the weight-loss oriented component will be delivered directly by the Flinders Program clinician for patients choosing this option. Many of these techniques can be delivered telephonically or electronically for follow ups (eg motivational weight loss text messages, sharing self-monitoring measures) if this suits the patient. If patients select alternative programs or resources to achieve their goals, this will be recorded and supported as part of the FP process. For other activities agreed between clinician and patient, local referral and community resources will be used (for example gyms, exercise groups, smoking cessation support services etc). Participants will be followed-up over a 6 month period to assist them to achieve their goals. Over a 6 month period, participation in the trial will include: 1 x Flinders Program delivery session (maximum of 1 hour) 2 x Questionnaires completion and baseline blood pressure, height and weight measurements at 0 and 6 months (30 minutes each) Optional: Meal replacement weight loss program (ImpromyTM program) with pharmacists’ support (and brief encounters) intermittently Clinician training in use of the Program is provided by Flinders University on a cost-recovery basis via face-to-face sessions or nationally and internationally via on-line modules. Integration of the Flinders Program with weight loss interventions: In usual care, activities towards any weight loss goals within the FP, include identifying and joining available community and health service-provided weight loss programs. There are commonly significant barriers to timely access to evidence-based weight loss programs (availability, timing, location, cost and quality and appropriateness to patient needs). Weight loss options that will be discussed with patients will include use of a meal replacement strategy, intensive support using behavioural techniques, and advice on how to access local community resources, such as gyms, exercise support groups, dieticians, exercise physiologists, etc. All patients will be offered the option of using a meal replacement strategy, which for the purposes of this study will be the ImpromyTM program which focuses on improving health through weight loss and good nutrition. It comprises nutritious and highly accepted meal replacements along with high protein meal. The program has been developed by the CSIRO and is pharmacist driven. The program will be carried out via several conveniently-located pharmacies which supply ImpromyTM. It usually costs AUD49.95 per person for registration and support material; and AUD3.95 per meal replacement. It will be provided at no cost to participants for the purposes of this study. Further details of the Chronic Condition Self-management in Obstructive Sleep Apnoea program can be found at http://www.csiro.au/Outcomes/Health-and-Wellbeing/Prevention/Impromy-Health-and- Weight-Management-Program.aspx. Whilst we anticipate that the vast majority of patients will accept the Impromy meal replacement program, they will not be excluded from the study if they decide to focus on alternative strategies, such as intensive behavioural support, to achieve weight loss. Patients will also receive usual sleep health care including an initial assessment and later review by asleep physician. Patients will likely, but not inevitably, commence CPAP therapy and for these patients, education about CPAP will be provided. Other therapies for OSA and the general health of the patient will be at the discretion of the treating physician as negotiated with the patient.

Sponsors

Dr Ching Li Chai-Coetzer
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Moderate to severe obstructive sleep apnoea defined as an Apnea Hypopnea Index (AHI) of 20/hour or more, Body Mass Index of 30 or more, ESS (Epworth Sleepiness Scale) score of 8 or more, Age 18-70, and Ability to give voluntary written consent and to complete English-language self-report instruments.

Exclusion criteria

Severe morbid obesity (body mass index [BMI]; neuromuscular disease; unstable psychiatric disease or cognitive impairment considered likely to interfere with adherence to instructions, completing the study or managing CPAP; hospitalization in the previous 3 months for myocardial infarction, unstable angina, cardiac failure, or cerebrovascular accident or New York Heart Association class III or IV symptoms; and lung disease with awake resting oxygen saturation of less than 92%). Patients who are pregnant, or are current participants in other research studies also will not be included.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026