Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/03/2019
Date assigned
18/04/2019
Last edited
18/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Around 1 in 4 people in the UK are seriously overweight (obese). Being obese makes it more likely that a person will develop diabetes, heart disease and some types of cancer. Extra body weight also puts a strain on muscles and joints, making it difficult and sometimes painful to move around. The aim of the DROPLET study, conducted in 2015-2017 was to investigate whether a GP referral of patients who are obese to a commercial low-energy total diet replacement (TDR) programme, could help these people to lose more weight than a weight loss programme provided by the practice nurse. 278 participants were recruited from GP practices across Oxfordshire CCG. The participants who were assigned to the TDR programme lost on average 10.7 kg after one year, compared with those assigned to the nurse advice who lost on average 3.1 kg, which resulted in an average difference between the groups of 7.2 kg in favour of the TDR group. These results clearly demonstrate that TDR is clinically effective at 1 year, and the health benefits are largely commensurate with the weight losses observed. However, there are concerns that a rapid weight may be followed with rapid regain, which could negate some of the health benefits. A better understanding of the longer-term effects on weight and health outcomes will help to determine whether the treatment is a cost-effective option in the longer term. 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 about 3 years from their original randomisation visit to measure body weight and collect other information on their health and weight control efforts.

Who can participate?
Adults who participated in the original DROPLET study

What does the study involve?
Participants are seen by a nurse or a member of the research team to collect measures of weight, body fat, waist circumference and a fasting blood sample to assess change in blood markers, such as cholesterol and insulin. This is to assess participants’ risk of developing heart disease or diabetes. Participants are also asked to complete questionnaires about weight control strategies. These measures collected at 3 years are compared with the same measures that were collected at the beginning of and during the main trial.

What are the possible benefits and risks of participating?
The risks of taking part are minimal, some people feel faint and have a small bruise where the blood sample has been collected.

Where is the study run from?
Oxfordshire Clinical Commissioning Group (UK)

When is the study starting and how long is it expected to run for?
March 2019 to September 2019

Who is funding the study?
1. Cambridge Weight Plan Ltd (UK)
2. National Institutes of Health Research Collaboration for Leadership in Health Research and Care (UK)

Who is the main contact?
Dr N Astbury
nerys.astbury@phc.ox.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Nerys Astbury

ORCID ID

http://orcid.org/0000-0001-9301-7458

Contact details

University Of Oxford
The Radcliffe Observatory Quarter Woodstock Road
Nuffield Department of Primary Care Health Sciences
Oxford
OX2 6GG
United Kingdom
+44 (0)1856617871
nerys.astbury@phc.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

13987

Study information

Scientific title

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

Acronym

Study hypothesis

The aim of the Extended follow up of the Doctor Referral of Overweight People to a Low-Energy Treatment (DROPLET) trial (https://www.isrctn.com/ISRCTN75092026) is to determine the clinical effectiveness, of referral to a low-energy total diet replacement programme compared with usual weight management interventions for long term weight management.

Ethics approval

South Central Oxford B Research Ethics Committee, Whitefriars, Level 3, Block B, Lewin's Mead, Bristol, BS1 2NTTel: +44 (0)207 1048058, Email: nrescommittee.southcentral-oxfordb@nhs.net, ref: 19/SC/0012

Study design

Observational follow-up study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Obesity

Intervention

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 the Doctor Referral of Overweight People to Low-Energy treatment (DROPLET) study whereby they were randomly assigned to either a TDR programme or usual care for weight loss, and were followed up at 1 year after randomisation. This study will invite those participants to attend an extended follow-up at 3 years after randomisation. There will be no further randomisation or additional intervention; 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 their health and weight control efforts.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Weight change from baseline to 3 years

Secondary outcome measures

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

Overall trial start date

01/03/2019

Overall trial end date

30/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

272

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/03/2019

Recruitment end date

30/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
The Radcliffe Observatory Quarter Woodstock Road
Oxford
OX2 6GG
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trial and Research Governance
Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
United Kingdom
+44 (0)1865 289885
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

https://researchsupport.admin.ox.ac.uk/ctrg

Funders

Funder type

Industry

Funder name

Cambridge Weight Plan UK Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NIHR CLAHRC Oxford

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal sometime in 2020.

IPD sharing statement
The current IPD data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/05/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/03/2019: Trial's existence confirmed by South Central - Oxford B Research Ethics Committee.