Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0071121999
Study information
Scientific title
National Service Framework Targets for Mental Health and Coronary Heart Disease (CHD): Obesity as an Eating Disorder - Weight Management Programme
Acronym
Study hypothesis
Can a combined holistic therapeutic approach to weight loss achieve weight reduction and empower clients to promote healthier lifestyles physiologically, psychologically and sociologically?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Obesity
Intervention
Qualitative and quantitative methods will be used:
Questionnaires will be the main quantitative measure.
Qualitative data will be collected from 12 participants using semi-structured interviews and narrative approaches, to encapsulate the participants perspective of the strengths and limitations of the study (What helped and what hindered their process?).
Focus Groups will be held monthly with a representative of the Primary Healthcare Team, Counsellors, GPs, patients and therapists involved.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Changes will be assessed at varied time points during the study period. In view of the multiple aims of the project, a range of outcome measures will be utilised. These have been selected for their relevance to this particular client group, sensitivity to change, psychometric properties and clinical (as well as research) utility. The formal outcome measures will be substantiated and supplemented by descriptions of the services offered and the development of the service.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
02/10/2002
Overall trial end date
01/10/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
There are 33 practices within the South East Primary Care Trust (SE PCT). GPs will be asked to recruit a total of 280 participants (8-9 patients per practice)
1. Identified as 'obese patient' (Obesity is most commonly defined by clinicians in terms of body mass index (BMI). A desirable BMI is considered to be in the region of 20 to 25. Anything above this is defined as 'obese')
2. BMI >30
3. Gender, both males or females accepted
4. Age over 16 years, no maximum
5. Commitment to the research process for 18 months
6. May have mild/moderate chronic illness, diabetes, CHD, irritable bowel syndrome (IBS), back pain
7. May have mild/moderate psychological disorders including anxiety and depression
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
280
Participant exclusion criteria
1. Pregnancy
2. Psychiatric illness, psychosis, schizophrenia
3. Patients who are already taking weight reduction medication
4. Metabolic dysfunction, ie thyroid problems, hormonal dysfunction
Recruitment start date
02/10/2002
Recruitment end date
01/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Manor Clinic
Sheffield
S12 2ST
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research council
Funder name
Sheffield Health and Social Research Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list