A feasibility study of WATCH IT: a community intervention to reduce morbidity in obese children
| ISRCTN | ISRCTN95431788 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95431788 |
| Secondary identifying numbers | 078174/Z/05/Z |
- Submission date
- 20/07/2007
- Registration date
- 08/08/2007
- Last edited
- 04/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Mary Rudolf
Scientific
Scientific
3-5 Belmont House
Belmont Grove
Leeds
LS2 9DE
United Kingdom
| Phone | +44 (0)113 392 6352 |
|---|---|
| mary.rudolf@leedsth.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| 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 | A feasibility study of WATCH IT: a community intervention to reduce morbidity in obese children - a randomised controlled trial |
| Study acronym | WATCH IT |
| Study objectives | This is a phase II trial which aims to assess the feasibility of conducting a definitive multicentre randomised controlled trial of the WATCH IT community programme for obese children. |
| Ethics approval(s) | Approval received from Leeds West Ethics Research Committee on the 3rd May 2006 (ref: O6/Q1205/14). |
| Health condition(s) or problem(s) studied | Childhood obesity |
| Intervention | The intervention is a community based programme to tackle obesity through one-to-one and group sessions. The control group is a 12 month wait list control. |
| Intervention type | Other |
| Primary outcome measure | The primary outcome is adiposity at 12 months. This will be assessed using % body fat by Dual Energy X-ray Absorptiometry (DEXA) scan, which will also provide more detailed outcomes relating to body fat: namely total and % fat mass, and total and % lean tissue, given as overall measures and broken down by region (abdomen, trunk, legs, arms). |
| Secondary outcome measures | Secondary outcomes of adiposity will be obtained from bioimpedance, BMI SD score and waist circumference at 6 and 12 months. Other secondary outcomes relate to feasibility (e.g. recruitment rate, attrition, acceptability etc.) plus, biomedical markers of morbidity, lifestyle, psycholoigal measures and physical fitness. |
| Overall study start date | 01/10/2006 |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 15 Years |
| Sex | Not Specified |
| Target number of participants | 70 |
| Key inclusion criteria | Young people aged 8 - 15 years with a BMI (Body Mass Index) above the 98th centile are eligible provided they and their principal carer have fluent English. |
| Key exclusion criteria | 1. Siblings of enrolled participants 2. Learning difficulties to a degree that precludes grasping the cognitivve component of the programme 3. Recent initiation of obesity reduction medication (for example, orlisat, metformin and sibutramine) 4. Young people with a medical cause for obesity or a psychiatric morbidity |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 01/07/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Belmont House Paediatrics (Leeds Primary Care Trust)
3-5 Belmont House
Leeds
LS2 9DE
United Kingdom
Leeds
LS2 9DE
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom
| Website | http://www.leeds.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 078174)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | pilot study results | 01/09/2006 | Yes | No | |
| Results article | RCT results | 01/12/2011 | Yes | No |
Editorial Notes
04/10/2017: internal review.
