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

Conditions

Overweight and obesity Nutritional, Metabolic, Endocrine Obesity

Dimitrios A. Koutoukidis, Susan A. Jebb, Paul Aveyard, Nerys M. Astbury

Obesity Facts2020-01-014 citations

Greater improvements in diet quality among overweight participants following a group-based commercial weight loss programme than those receiving support to lose weight in primary care

Gina L. Ambrosini, Ivonne Solis‐Trapala, Amy L. Ahern, Nicholas R. Fuller, Christina Holzapfel et al. (8 authors)

Nutrition Journal2018-07-0410 citations

10.1186/s12937-018-0370-x

Weight loss referrals for adults in primary care (WRAP): protocol for a multi-centre randomised controlled trial comparing the clinical and cost-effectiveness of primary care referral to a commercial weight loss provider for 12 weeks, referral for 52 weeks, and a brief self-help intervention [ISRCTN82857232].

Ahern AL, Aveyard PN, Halford JC, Mander A, Cresswell L, Cohn SR, Suhrcke M, Marsh T, Thomson AM, Jebb SA.

2014-06-1820 citations

10.1186/1471-2458-14-620

Primary care referral to a commercial provider for weight loss treatment versus standard care: a randomised controlled trial.

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.

2011-09-07277 citations

10.1016/s0140-6736(11)61344-5

Interventions

GP referral to WW for 12 months versus standard GP management for weight loss for 12 months.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Australia, Germany, United Kingdom

Outcome results

None listed