DROPLET extended follow-up
Research type
Research Study
Full title
Extended follow-up of participants in the DROPLET randomised controlled trial.
IRAS ID
251781
Contact name
Nerys Astbury
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
ISRCTN Number
ISRCTN12311645
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Research Summary:
The DROPLET trial (Ethics Ref: 15/SC/0337) was an individually randomised trial whereby patients who had a BMI ≥30kg/m2 were randomised to receive a free referral to a commercial low-energy TDR weight loss programme or usual care. At 12 months those allocated to the TDR group lost on average 10.7kg, whilst those assigned to usual care lost an average 3.1kg – an adjusted mean difference between groups of 7.2kg favouring the TDR group.
However the longer term effects on weight are unknown and theer is a concerns that rapid weight loss may lead to more rapid weight regain. The aim of this study is to contact the original participants in the DROPLET trial to invite them to enrol in this study and to attend a new appointment approximately 3 years from their original randomisation visit to measure body weight and collect other information on their health and weight control efforts. This will allow us to study weight regain after weight loss and to use this information to provide more reliable estimates of the long term health care impact of weight loss interventions.Summary of results:
To purpose of this study was to see if a total diet replacement programme (TDR) was effective in the long term (3 years).Participants who took part in the main DROPLET trial were randomised to a TDR weight loss treatment of usual care.
The TDR group followed a 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.Outcome measures were collected from 179 of the 272 participants recruited were followed at 3 years . At 3 years the TDR group lost −6.2 kg (SD 9.1) and usual care −2.7 kg (SD 7.7) compared with when they stared the trial. adjusted mean difference −3.3 kg (95% CI: −5.2, −1.5), p < 0.0001. Weight Regain was greater in TDR group +8.9 kg (SD 9.4) than UC + 1.2, (SD 9.1); adjusted mean difference +6.9 kg (95% CI 4.2, 9.5) P < 0.001.
At 3 years TDR led to greater reductions than UC in diastolic blood pressure (mean difference −3.3 mmHg (95% CI:−6.2; −0.4) P = 0.024), and systolic blood pressure (mean differences −3.7 mmHg (95% CI: −7.4; 0.1) P = 0.057). There was no evidence of differences between groups in the change from baseline to 3 years HbA1c (−1.9 mmol/mol (95% CI: −0.7; 4.5; P = 0.15), LDL cholesterol concentrations (0.2 mmol/L (95% CI −0.3, 0.7) P = 0.39), cardiovascular risk score (QRISK2) (−0.37 (95% CI −0.96; 0.22); P = 0.22).Treatment of people with obesity with a TDR programme compared with support from a practice nurse leads to greater weight loss which persists to at least 3 years, but there was only evidence of sustained improvements in BP and not in other aspects of cardiometabolic risk.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0012
Date of REC Opinion
18 Jan 2019
REC opinion
Favourable Opinion