A randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countries

ISRCTN	ISRCTN85485463
DOI	https://doi.org/10.1186/ISRCTN85485463
Protocol serial number	6202
Sponsor	Medical Research Council Human Nutrition Research (UK)
Funder	WeightWatchers International Inc. (UK)

Submission date: 03/08/2007
Registration date: 08/08/2007
Last edited: 06/07/2018

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

Dr Susan Jebb
Scientific

MRC Human Nutrition Research
Elsie Widdowson Laboratory
120 Fulbourn Road
Cambridge
CB1 9NL
United Kingdom

Phone	+44 (0)1223 426356
Email	susan.jebb@mrc-hnr.cam.ac.uk

Study information

Primary study design	Interventional
Study design	12-month multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countries
Study acronym	WW Global Effectiveness Trial
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	Overweight and obesity
Intervention	GP referral to WW for 12 months versus standard GP management for weight loss for 12 months.
Intervention type	Behavioural
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.
Key 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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	804
Key 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.
Key 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.
Date of first enrolment	01/07/2007
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

United Kingdom
England
Australia
Germany

Study participating centre

MRC Human Nutrition Research

Cambridge
CB1 9NL
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	results	22/10/2011		Yes	No
Results article	cost-effectiveness results	01/06/2013		Yes	No
Results article	results	01/06/2014		Yes	No
Results article	results	04/07/2018		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/07/2018: Publication reference added.