Extended follow-up of participants in the DROPLET randomised controlled trial

Participants enrolled in the DROPLET randomised controlled trial which compared referral to a commercial total diet replacement (TDR) weight loss programme with usual care weight management on weight at 3 years

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12311645

Enrollment

272

Registered

2019-04-18

Start date

2019-03-01

Completion date

Unknown

Last updated

2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

This is an extended follow-up of the participants who were enrolled in the DROPLET randomised controlled trial (https://www.isrctn.com/ISRCTN75092026). Eligible participants have already taken part in

this is an observational follow-up only. The participants attend a new appointment approximately 3 years from their original randomisation visit to measure body weight and collect other information on

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participant in the original DROPLET randomised controlled trial and consented to re-contact

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
Weight change from baseline to 3 years	—

Secondary

Measure	Time frame
Proportion of participants in each group achieving 5% weight loss at 3 years Proportion of participants in each group achieving 10% weight loss at 3 years Change in fat mass between baseline and 3 years Change in LDL cholesterol between baseline and 3 years Change in HbA1c between baseline and 3 years Change in systolic and diastolic blood pressure between baseline and 3 years Change in QRISK2 between baseline and 3 years	—

Measure

Time frame

Proportion of participants in each group achieving 5% weight loss at 3 years Proportion of participants in each group achieving 10% weight loss at 3 years Change in fat mass between baseline and 3 years Change in LDL cholesterol between baseline and 3 years Change in HbA1c between baseline and 3 years Change in systolic and diastolic blood pressure between baseline and 3 years Change in QRISK2 between baseline and 3 years

—

Countries

England, United Kingdom

Contacts

Public ContactNerys Astbury

nerys.astbury@phc.ox.ac.uk+44 (0)1856617871

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026