Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/07/2007
Date assigned
08/08/2007
Last edited
20/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.watch-it.org.uk

Contact information

Type

Scientific

Primary contact

Prof Mary Rudolf

ORCID ID

Contact details

3-5 Belmont House
Belmont Grove
Leeds
LS2 9DE
United Kingdom
+44 (0)113 392 6352
mary.rudolf@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

078174/Z/05/Z

Study information

Scientific title

Acronym

WATCH IT

Study hypothesis

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

Approval received from Leeds West Ethics Research Committee on the 3rd May 2006 (ref: O6/Q1205/14).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

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

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

Phase

Phase II

Drug names

Primary outcome measures

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 trial start date

01/10/2006

Overall trial end date

01/07/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

70

Participant 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

Recruitment start date

01/10/2006

Recruitment end date

01/07/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

3-5 Belmont House
Leeds
LS2 9DE
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Woodhouse Lane
Leeds
LS2 9JT
United Kingdom

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 078174)

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

1. 2006 pilot trial results in http://www.ncbi.nlm.nih.gov/pubmed/16531453
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22024104

Publication citations

  1. Pilot trial results

    Rudolf M, Christie D, McElhone S, Sahota P, Dixey R, Walker J, Wellings C, WATCH IT: a community based programme for obese children and adolescents., Arch. Dis. Child., 2006, 91, 9, 736-739, doi: 10.1136/adc.2005.089896.

  2. Results

    Bryant M, Farrin A, Christie D, Jebb SA, Cooper AR, Rudolf M, Results of a feasibility randomised controlled trial (RCT) for WATCH IT: a programme for obese children and adolescents., Clin Trials, 2011, 8, 6, 755-764, doi: 10.1177/1740774511424766.

Additional files

Editorial Notes