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 |
| Secondary identifying numbers | eMed001 |
- 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
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
| Study design | Descriptive case series retrospective observational study in a single centre |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a 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 hypothesis | 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. |
| Condition | 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 | 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. |
| Secondary outcome measures | 1. Patient satisfaction measured using the NHS "Friends and family test" question throughout the duration of the study 2. Frequency, severity and nature of adverse events and side effects measured using an internally-developed side-effect reporting questionnaire throughout the duration of the study 3. Engagement with programme components such as check-ins measured using internal data to determine the percentage of recommended programme activities that the patient completes throughout the study 4. Drop out rate and any reasons provided for leaving the Programme measured using patient self-reporting at the end of the study 5. Weight loss of participants compared to that described in evaluations of other programmes measured using validated weight measurements collected at baseline and at the end of the study |
| Overall study start date | 01/10/2024 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Participant inclusion criteria | Patients who took part in the Programme provided by the treatment centre |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/11/2024 |
| Recruitment end date | 01/04/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centre
London
NW1 3HP
United Kingdom
Sponsor information
Industry
184-192 Drummond Street
London
NW1 3HP
England
United Kingdom
| Phone | +44 330 303 8000 |
|---|---|
| charlie@emed.com | |
| Website | http://www.emed.com/uk |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be published as a supplement to the results publication. |
Editorial Notes
21/10/2024: Trial's existence confirmed by Science 37.
