A feasibility study of WATCH IT: a community intervention to reduce morbidity in obese children

ISRCTN	ISRCTN95431788
DOI	https://doi.org/10.1186/ISRCTN95431788
Protocol serial number	078174/Z/05/Z
Sponsor	University of Leeds (UK)
Funder	The Wellcome Trust (UK) (grant ref: 078174)

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

3-5 Belmont House
Belmont Grove
Leeds
LS2 9DE
United Kingdom

Phone	+44 (0)113 392 6352
Email	mary.rudolf@leedsth.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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).
Key secondary outcome measure(s)	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.
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 sample size at registration	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

United Kingdom
England

Study participating centre

Belmont House Paediatrics (Leeds Primary Care Trust)

3-5 Belmont House
Leeds
LS2 9DE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/10/2017: internal review.