Contact information
Type
Scientific
Primary contact
Dr Susan Jebb
ORCID ID
Contact details
MRC Human Nutrition Research
Elsie Widdowson Laboratory
120 Fulbourn Road
Cambridge
CB1 9NL
United Kingdom
+44 (0)1223 426356
susan.jebb@mrc-hnr.cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6202
Study information
Scientific title
A randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countries
Acronym
WW Global Effectiveness Trial
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).
Ethics approval
1. UK: Nottingham Research Ethics Committee 2, 30/04/2007, ref: 07/Q2404/40
2. Australia: Sydney SW Area Health Service (RPAH Zone), 14/05/2007, ref. X07-0089
3. Germany: Ethics Committee of Fakultat (Ethikkommission de Fakultat fur Medizin der TUM), 18/05/2007, ref. 1812/07
Study design
12-month multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Overweight and obesity
Intervention
GP referral to WW for 12 months versus standard GP management for weight loss for 12 months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/07/2007
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
804 (268 per country)
Participant 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.
Recruitment start date
01/07/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Australia, Germany, United Kingdom
Trial participating centre
MRC Human Nutrition Research
Cambridge
CB1 9NL
United Kingdom
Sponsor information
Organisation
Medical Research Council Human Nutrition Research (UK)
Sponsor details
c/o Dr Ann Prentice
MRC Human Nutrition Research
Elsie Widdowson Laboratory
120 Fulbourn Road
Cambridge
CB1 9YQ
United Kingdom
+44 (0)1223 426356
ann.prentice@mrc-hnr.cam.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
WeightWatchers International Inc. (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
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21906798
2013 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/22929209
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25826767
Publication citations
-
Results
Jebb SA, Ahern AL, Olson AD, Aston LM, Holzapfel C, Stoll J, Amann-Gassner U, Simpson AE, Fuller NR, Pearson S, Lau NS, Mander AP, Hauner H, Caterson ID, Primary care referral to a commercial provider for weight loss treatment versus standard care: a randomised controlled trial., Lancet, 2011, 378, 9801, 1485-1492, doi: 10.1016/S0140-6736(11)61344-5.
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Fuller NR, Colagiuri S, Schofield D, Olson AD, Shrestha R, Holzapfel C, Wolfenstetter SB, Holle R, Ahern AL, Hauner H, Jebb SA, Caterson ID, A within-trial cost-effectiveness analysis of primary care referral to a commercial provider for weight loss treatment, relative to standard care--an international randomised controlled trial., Int J Obes (Lond), 2013, 37, 6, 828-834, doi: 10.1038/ijo.2012.139.
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Results
Fuller NR, Williams K, Shrestha R, Ahern AL, Holzapfel C, Hauner H, Jebb SA, Caterson ID, Changes in physical activity during a weight loss intervention and follow-up: a randomized controlled trial, Clin Obes, 2014, 4, 3, 127-135, doi: 10.1111/cob.12057.