Welcome
Support Centre
24 April 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
A randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countries
ISRCTN ISRCTN85485463
DOI 10.1186/ISRCTN85485463
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countries
Scientific title
Acronym WW Global Effectiveness Trial
Serial number at source 6202
Study hypothesis The purpose of the study is to compare the effectiveness of WeightWatchers (WW), a commercial weight-loss programme, with current standard General Practitioner (GP) weight-loss treatment for overweight adults, as informed by national guidelines in three countries (the UK, Australia and Germany).
Lay summary Not provided at time of registration
Ethics approval 1. UK: Nottingham Research Ethics Committee 2 on the 30th April 2007 (ref: 07/Q2404/40)
2. Australia: Sydney SW Area Health Service (RPAH Zone) on the 14th May 2007 (ref. X07-0089)
3. Germany: Ethics Committee of Fakultat (Ethikkommission de Fakultat fur Medizin der TUM) on the 18th May 2007 (ref. 1812/07)
Study design 12-month multi-centre randomised controlled trial
Countries of recruitment Australia, Germany, United Kingdom
Disease/condition/study domain Overweight and obesity
Participants - inclusion criteria Men and women who are overweight and with evidence of some increased risk of obesity-related disease will be eligible for the trial. Participants will be male and female adults aged 18+ years, with a body mass index of 27 - 35 kg/m^2 and one or more of the following risk factors:
1. Family history of diabetes mellitus
2. Controlled type 2 diabetes mellitus not treated with insulin*
3. Previous gestational diabetes mellitus
4. Impaired glucose tolerance/impaired fasting glycaemia
5. Mild-moderate dyslipidaemia, or treatment for dyslipidaemia
6. Treatment for hypertension
7. Central adiposity (waist circumference greater than 88 cm in women or greater than 102 cm in men)
8. Polycystic ovary syndrome/infertility without apparent cause other than weight
9. Lower limb osteoarthritis
10. Abdominal hernia

* Patients with type 2 diabetes treated with sulphonylureas will be eligible for inclusion but GPs will be advised to instruct them to closely monitor their glucose levels due to the additional risk of hypoglycaemia during weight loss, and to regularly review their medication. The number of people with diabetes recruited to the study will be limited to a maximum of 50% of the total sample.
Participants - exclusion criteria Factors which may affect weight:
1. Recent weight loss of greater than 5 kg in the previous 3 months
2. History of clinically-diagnosed eating disorder
3. Orthopaedic limitations preventing participation in regular physical activity
4. Untreated thyroid disease or greater than one change in thyroid medication over previous 6 months
5. Taking any prescription medication with known effects on appetite or weight (according to National Medicines Formulary)
6. Taking oral steroids
7. Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome acceptable)
8. Previous surgical procedure for weight loss
9. Major surgery within previous 3 months
10. Pregnancy or lactation

Co-exisiting disease:
11. Insulin-treated diabetes mellitus
12. HbA1c greater than 9.0%
13. Diagnosis of type 2 diabetes within previous 6 months
14. Heart problems within previous 3 months (e.g. angina, myocardial infarction, stroke) or implanted cardiac defibrillator or pacemaker
15. Uncontrolled hypertension (greater than 160/95 mmHg)
16. Having started taking a new prescription medication within 3 months
17. Change in dosage of a prescription medication within 1 month
18. History or presence of cancer (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrolment)

Participants will also be excluded if they have participated in another clinical trial within 30 days prior to enrolment.

Participants must be willing to be involved in a lifestyle-based weight-loss programme for a 12-month period, and able to attend weekly meetings (free of charge) for the duration if required.
Anticipated start date 01/07/2007
Anticipated end date 31/12/2009
Status of trial Completed
Patient information material
Target number of participants 804 (268 per country)
Interventions GP referral to WW for 12 months versus standard GP management for weight loss for 12 months.
Primary outcome measure(s) To examine the differences in weight loss at 12 months between the WW programme and standard GP management for weight loss (as informed by national guidelines) across three countries.
Secondary outcome measure(s) 1. To investigate numbers of subjects losing 5% and 10% of baseline weight in each group
2. To investigate changes in a number of indicators of metabolic disease in both groups - to include body composition (bio-impedance analysis), simple indices of insulin sensitivity (HOMA-IR) , lipid profile, liver function and inflammatory markers, measured at baseline and at 6 and 12 months
3. To explore the impact of the treatments on eating behaviour (Three Factor Eating Questionnaire [TFEQ-R21]), physical activity (International Physical Activity Questionnaire short version [IPAQ-short]) and quality of life (Impact of Weight on Quality Of Life [IWQOL-lite]), assessed at baseline and at 6 and 12 months
4. To examine cost of the WW programme vs standard GP care for weight loss
5. To investigate the temporal pattern of change in body weight over all measured time points
6. To qualitatively explore participants' experiences of the two weight-loss programmes (focus groups), assessed at baseline and at 6 and 12 months
Sources of funding WeightWatchers International Inc. (UK)
Trial website
Publications 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21906798
2013 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/22929209
Contact name Dr  Susan  Jebb
  Address MRC Human Nutrition Research
Elsie Widdowson Laboratory
120 Fulbourn Road
  City/town Cambridge
  Zip/Postcode CB1 9NL
  Country United Kingdom
  Tel +44 (0)1223 426356
  Fax +44 (0)1223 437515
  Email susan.jebb@mrc-hnr.cam.ac.uk
Sponsor Medical Research Council Human Nutrition Research (UK)
  Address c/o Dr Ann Prentice
MRC Human Nutrition Research
Elsie Widdowson Laboratory
120 Fulbourn Road
  City/town Cambridge
  Zip/Postcode CB1 9YQ
  Country United Kingdom
  Tel +44 (0)1223 426356
  Fax +44 (0)1223 437515
  Email ann.prentice@mrc-hnr.cam.ac.uk
  Sponsor website: http://www.mrc-hnr.cam.ac.uk/
Date applied 03/08/2007
Last edited 05/03/2014
Date ISRCTN assigned 08/08/2007
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.