The effect of a novel high-adherence weight loss programme in achieving weight loss and other health benefits
| ISRCTN | ISRCTN12421711 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12421711 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | eMed001 |
| Sponsor | eMed Healthcare UK Ltd |
| Funder | eMed Healthcare UK Ltd |
- Submission date
- 16/10/2024
- Registration date
- 21/10/2024
- Last edited
- 21/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
This study (the “Study”) is designed to assess the effectiveness and acceptability of a novel weight management programme (the “Programme”). The Programme is structured around a mobile application, and aims to provide a high-adherence model of care, support and guidance to participants in order to lose weight. Participants may also be prescribed medication to support their weight loss efforts as part of the Programme where this is deemed clinically appropriate following individual clinical review.
Who can participate?
Adults between the ages of 18 and 65 who meet the eligibility criteria and live in England or Wales. Participants will agree to the normal terms of the Programme, including any monthly fee associated.
What does the study involve?
The Programme involves regular check-ins including weight, side effect monitoring, blood tests and questionnaires. This data will be collected and analyzed as part of this study to draw conclusions concerning the effectiveness and acceptability of the Programme.
What are the possible benefits and risks of participating?
The expected benefit is weight loss and reduction of the complications associated with obesity. In addition, participants will be supported during their journey.
Medications may be prescribed to patients as part of the Programme if this is considered to be appropriate following individual clinical review. Side effects and risks of any medication prescribed will be discussed with patients at the point of prescribing, and informed consent obtained.
Where is the study run from?
eMed Healthcare UK Ltd
When is the study starting and how long is it expected to run for?
October 2024 to December 2025
Who is funding the study?
eMed Healthcare UK Ltd
Who is the main contact?
Dr Matthew Noble, matthew.noble@emed.com
Contact information
Public, Scientific, Principal investigator
184-192 Drummond Street
London
NW1 3HP
United Kingdom
 ORCID ID |
0000-0003-1174-186X |
|---|---|
| Phone | +44 330 303 8000 |
| matthew.noble@emed.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Descriptive case series retrospective observational study in a single centre |
| Secondary study design | Case series |
| Study type | Participant information sheet |
| Scientific title | The effect of and satisfaction with a novel high-adherence weight loss programme in achieving weight loss and other health benefits in adults with obesity: a retrospective observational study |
| Study acronym | HAWLoP |
| Study objectives | To evaluate the effectiveness and acceptability of a novel high adherence weight management support programme. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | This is a retrospective observational study that does not involve any randomisation, treatment or management changes. |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | This study is designed to assess the effectiveness and acceptability of a novel weight management programme (the “Programme”). The Programme is structured around a mobile application, and aims to provide a high-adherence model of care, support and guidance to participants in order to lose weight. Participants may also be prescribed medication to support their weight loss efforts as part of the Programme where this is deemed clinically appropriate following individual clinical review. The Programme involves regular check-ins including weight, side effect monitoring, blood tests and questionnaires. The Programme is already established and collects information on participation, outcomes, satisfaction, side effects, blood test data and other questionnaires as part of usual treatment. This study is designed to retrospectively analyze this routinely-collected data in order to draw conclusions concerning the effectiveness and acceptability of the Programme. The duration of the study is six months. Patients will be followed up for a further six months. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
BMI kg/m² measured using validated weight and self-reported height at baseline and validated weight and self-reported height at monthly intervals. Weight will be validated by directly observing the participant on a weighing-scale by video call. |
| Key secondary outcome measure(s) |
1. Patient satisfaction measured using the NHS "Friends and family test" question throughout the duration of the study |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | All |
| Target sample size at registration | 1000 |
| Key inclusion criteria | Patients who took part in the Programme provided by the treatment centre |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/11/2024 |
| Date of final enrolment | 01/04/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
Study participating centre
London
NW1 3HP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/10/2024: Trial's existence confirmed by Science 37.
