Extended follow-up of a short total diet replacement programme: results of the Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET) randomised controlled trial at 3 years

• Published in: International Journal of Obesity 2021-11, Vol.45 (11), p.2432-2438
• Main Authors: Astbury, Nerys M., Edwards, Rhiannon M., Ghebretinsea, Fitsum, Shanyinde, Milensu, Mollison, Jill, Aveyard, Paul, Jebb, Susan A.
• Format: Article
• Language: English
• Subjects: 692/308/575; 692/700/2817; Adult; Aftercare - methods; Aftercare - statistics & numerical data; Biomarkers; Blood pressure; Body weight; Body weight loss; Cardiovascular diseases; Cholesterol; Diabetes mellitus; Diet; Diet therapy; Diet Therapy - methods; Diet Therapy - standards; Diet Therapy - statistics & numerical data; Epidemiology; Follow-Up Studies; Health care; Health Promotion and Disease Prevention; Health risks; Humans; Internal Medicine; Low density lipoprotein; Low-calorie diet; Male; Medicine; Medicine & Public Health; Metabolic Diseases; Middle Aged; Nutrient deficiency; Obesity; Overweight; Overweight - diet therapy; Overweight - epidemiology; Patient outcomes; Public Health; Referral and Consultation - standards; Referral and Consultation - statistics & numerical data; Reintroduction; Risk; United Kingdom - epidemiology; Weight control; Weight loss; Weight Reduction Programs - methods; Weight Reduction Programs - standards; Weight Reduction Programs - statistics & numerical data
• ISSN: 0307-0565; 1476-5497
• DOI: 10.1038/s41366-021-00915-1

Objectives To test the long-term effectiveness of a total diet replacement programme (TDR) for routine treatment of obesity in a primary care setting. Methods This study was a pragmatic, two-arm, parallel-group, open-label, individually randomised controlled trial in adults with obesity. The outcomes were change in weight and biomarkers of diabetes and cardiovascular disease risk from baseline to 3 years, analysed as intention-to-treat with mixed effects models. Interventions The intervention was TDR for 8 weeks, followed by food-reintroduction over 4 weeks. Behavioural support was provided weekly for 8 weeks, bi-weekly for the next 4 weeks, then monthly for 3 months after which no further support was provided. The usual care (UC) group received dietary advice and behavioural support from a practice nurse for up to 3 months. Results Outcome measures were collected from 179 (66%) participants. Compared with baseline, at 3 years the TDR group lost −6.2 kg (SD 9.1) and usual care −2.7 kg (SD 7.7); adjusted mean difference −3.3 kg (95% CI: −5.2, −1.5), p