Extended follow-up of participants in the DROPLET randomised controlled trial
| ISRCTN | ISRCTN12311645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12311645 |
| Secondary identifying numbers | 13987 |
- Submission date
- 13/03/2019
- Registration date
- 18/04/2019
- Last edited
- 01/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Public
University Of Oxford
The Radcliffe Observatory Quarter Woodstock Road
Nuffield Department of Primary Care Health Sciences
Oxford
OX2 6GG
United Kingdom
 ORCID ID |
0000-0001-9301-7458 |
|---|---|
| Phone | +44 (0)1856617871 |
| nerys.astbury@phc.ox.ac.uk |
Study information
| Study design | Observational follow-up study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2019 |
| Completion date | 30/09/2019 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 272 |
| Total final enrolment | 179 |
| Key inclusion criteria | Participant in the original DROPLET randomised controlled trial and consented to re-contact |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/03/2019 |
| Date of final enrolment | 30/09/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Woodstock Road
Oxford
OX2 6GG
United Kingdom
Sponsor information
University/education
Clinical Trial and Research Governance
Joint Research Office
1st floor, Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 289885 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | https://researchsupport.admin.ox.ac.uk/ctrg |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 01/05/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal sometime in 2020. |
| IPD sharing plan | The current IPD data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/07/2021 | 01/10/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
22/03/2019: Trial's existence confirmed by South Central - Oxford B Research Ethics Committee.
