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
Secondary identifying numbers 6202
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

Study design12-month multi-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countries
Study acronymWW Global Effectiveness Trial
Study objectivesThe 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) studiedOverweight and obesity
InterventionGP referral to WW for 12 months versus standard GP management for weight loss for 12 months.
Intervention typeBehavioural
Primary outcome measureTo 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 measures1. 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 study start date01/07/2007
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants804 (268 per country)
Key inclusion criteriaMen 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 criteriaFactors 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 enrolment01/07/2007
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Australia
  • England
  • Germany
  • United Kingdom

Study participating centre

MRC Human Nutrition Research
Cambridge
CB1 9NL
United Kingdom

Sponsor information

Medical Research Council Human Nutrition Research (UK)
Government

c/o Dr Ann Prentice
MRC Human Nutrition Research
Elsie Widdowson Laboratory
120 Fulbourn Road
Cambridge
CB1 9YQ
United Kingdom

Phone +44 (0)1223 426356
Email ann.prentice@mrc-hnr.cam.ac.uk
Website http://www.mrc-hnr.cam.ac.uk/
ROR logo "ROR" https://ror.org/050pqs331

Funders

Funder type

Industry

WeightWatchers International Inc. (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

Editorial Notes

06/07/2018: Publication reference added.