National Service Framework Targets for Mental Health and Coronary Heart Disease (CHD): Obesity as an Eating Disorder - Weight Management Programme
| ISRCTN | ISRCTN12343040 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12343040 |
| Secondary identifying numbers | N0071121999 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 07/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kath Sharman
Scientific
Scientific
The Manor Clinic
18 Ridgeway Road
Sheffield
S12 2ST
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | National Service Framework Targets for Mental Health and Coronary Heart Disease (CHD): Obesity as an Eating Disorder - Weight Management Programme |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 02/10/2002 |
| Completion date | 01/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 280 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/10/2002 |
| Date of final enrolment | 01/10/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Manor Clinic
Sheffield
S12 2ST
United Kingdom
S12 2ST
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Research council
Sheffield Health and Social Research Consortium (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
