Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kath Sharman

ORCID ID

Contact details

The Manor Clinic
18 Ridgeway Road
Sheffield
S12 2ST
United Kingdom

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes