Audio unconscious persuasion for weight loss in overweight adults
| ISRCTN | ISRCTN75203062 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75203062 |
| Secondary identifying numbers | PSYETH (UPTD) 12/13 71 |
- Submission date
- 13/02/2020
- Registration date
- 27/02/2020
- Last edited
- 23/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Weight loss interventions using audio unconscious persuasion are increasingly popular. However, no robust trials have been conducted to assess their effectiveness.
The aim of this trial is to assess the effectiveness of an audio unconscious persuasion weight loss intervention incorporating techniques from NLP and hypnosis (Slimpod®) compared to audio relaxation (control) on weight loss and other measures.
Who can participate?
Healthy adult volunteers with BMI > 25 kg/m²
What does the study involve?
Participants will be randomly allocated to the intervention or control groups.
The intervention is Slimpod®, a nine-minute long digital audio recording focused on changing behaviours and attitudes related to diet and weight. Participants listen to the recording once a day for 24 weeks at a time and place of their choosing. Recordings are available in two formats: digital file (.MP3) and compact disc (CD); participants can select their preferred format.
The control group are asked to listen to nine-minute long recording informed by the principles of relaxation therapy once a day for 24 weeks. The control recording does not include a focus on behaviour change.
What are the possible benefits and risks of participating?
Benefits of participating: The potential to lose weight with the need for willpower or conscious effort such as conscious calorie restriction. There is no risk in participating.
Where is the study run from?
City University London (UK)
When is the study starting and how long is it expected to run for?
October 2013 to July 2014
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Christopher Roycroft-Davis
chris@thinkingslimmer.com
Contact information
Scientific
400 Harrow Road
London
W9 2HU
United Kingdom
 ORCID ID |
0000-0003-3356-1544 |
|---|---|
| Phone | +44 (0)207 760 7596 |
| chris@thinkingslimmer.com |
Study information
| Study design | Pilot randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Revolutionising participants' health and wellbeing through Neuro-reprogramming via Slimpod® app: a RCT |
| Study objectives | The aim of this pilot randomised controlled trial is to assess the effectiveness of an audio unconscious persuasion weight loss intervention incorporating techniques from NLP and hypnosis (Slimpod®) compared to audio relaxation (control) on weight (primary outcome), eating self-efficacy, exercise confidence, and quality of life (secondary outcomes). |
| Ethics approval(s) | Approved 09/10/2013, Research and ethics committee of the department of psychology of City University London (Jay Leighton, Executive Assistant, School of Arts & Social Sciences, D217, Rhind Building, City, University of London, Northampton Square, London, EC1V 0HB, UK; +44 (0)20 7040 3362; jay.leighton@city.ac.uk), ref: PSYETH (UPTD) 12/13 71 |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | The intervention is Slimpod®, a nine-minute long digital audio recording focused on changing behaviours and attitudes related to diet and weight. Participants listen to the recording once a day for 24 weeks at a time and place of their choosing. Recordings are available in two formats: digital file (.MP3) and compact disc (CD); participants can select their preferred format. The control group are asked to listen to nine-minute long recording informed by the principles of relaxation therapy once a day for 24 weeks. The control recording does not include a focus on behaviour change. To assess the effectiveness of an audio unconscious persuasion weight loss intervention called Slimpod® compared to audio relaxation (control), overweight adults (i.e., age < 18 years, self-reported Body Mass Index < 25.0 kg/m²) will be randomized to intervention and control groups. Weight (primary outcome) will be assessed at trial commencement, mid-trial (12 weeks) and trial end (24 weeks). Secondary outcomes are assessed using the Eating Self-Efficacy Scale (ESES), Exercise Confidence Scale (ECS) and Quality of Life Index Generic Version III (QLI-G3) at the start and end of the trial. The nine-minute Slimpod audio recording and the nine-minute control audio are provided to participants as MP3 files to be listened to daily every day for 24 weeks. Simple randomization is used to allocate participants to the intervention or control groups using a 1:1 allocation ratio. A computer programme operated by the study researcher is used to generate a random number to assign each participant to a trial arm. The trial statistician is not involved in the process of recruitment, randomization, or group assignment. Blinding It is not possible to blind participants to their group allocation. Participants became aware of their allocation on first listening to the audio recording they had received as the recording for those in the intervention group included weight loss messages, whereas the control group recording did not. Statistical methods Data analysis is conducted using R version 3.4.3. Baseline characteristics are reported as mean and standard deviation (SD) for continuous data and n (%) for categorical data. For each measure, baseline is defined as the value collected prior to the commencement of randomised therapy. The two therapy arms are compared using analysis of covariance (ANCOVA) using the change from baseline at each post-baseline assessment separately, with the baseline fitted as a covariate; interaction between baseline and treatment are assessed but removed from the model as not statistically significant. |
| Intervention type | Behavioural |
| Primary outcome measure | Weight (kg) at baseline, 12, and 24-weeks |
| Secondary outcome measures | At baseline and 24-weeks: 1. Eating Self-Efficacy Scale (ESES) 2. Exercise Confidence Scale (ECS) 3. Quality of Life Index Generic Version III (QLI-G3) |
| Overall study start date | 14/01/2014 |
| Completion date | 01/07/2014 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 82 |
| Total final enrolment | 82 |
| Key inclusion criteria | 1. BMI above 25 kg/m² 2. Aged 18 years or above |
| Key exclusion criteria | 1. Pregnant 2. Diagnosed with mental health condition 3. Seeking medical support for a medical diagnosis unless prior consent was obtained from their medical practitioner |
| Date of first enrolment | 05/10/2013 |
| Date of final enrolment | 01/01/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clerkenwell
London
EC1V 0HB
United Kingdom
Sponsor information
Industry
400 Harrow Road
London
W9 2HU
United Kingdom
| Phone | +44 (0)7770381733 |
|---|---|
| chris@thinkingslimmer.com | |
| Website | https://www.ThinkingSlimmer.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 12/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Poster presentation at the British Journal of General Practitioners' research conference on March 12, 2020. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request, data will be available from April 2, 2020 indefinitely. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 18/06/2020 | 23/09/2021 | No | No |
Editorial Notes
23/09/2021: The following changes have been made:
1. Abstract added.
2. The final enrolment number has been added from the reference.
27/02/2020: Trial’s existence confirmed by City University of London.
