Overweight and ObesityNCT03602001
Attentive Eating for Weight Loss
A study testing Attentive eating smartphone application. and Standard dietary advice and text tips. in people with Overweight and Obesity, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
This trial examined whether a smartphone application designed to encourage a more attentive eating style could help people to lose weight, compared to a control group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Attentive eating smartphone application. and Standard dietary advice and text tips.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Sep 2017to 11 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥25.0 kg/m2
- Self-report would like to lose weight by changing their dietary behaviour
- 18-65 years
- Fluent English
- Own an Android/Apple smartphone
Who cannot join
- History of eating disorders or food allergies
- Medication that affects appetite
- Pregnant
- Scheduled for weight loss survey during the trial
- Currently on a structured weight loss programme (e.g. Weight Watchers)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Liverpool
Liverpool, Merseyside, L69 3BX
About this study
Official title: Attentive Eating for Weight Loss: Proof of Concept Non-blinded Randomised Control Trial
This trial examined whether a smartphone application designed to encourage a more attentive eating style could help people to lose weight, compared to a control group.
Read the detailed description
There is evidence that enhancing memory for recent eating and focusing attention on food being consumed influences later energy intake. Studies have shown that attending to food being eaten can reduce food intake. This has since been implemented into a smartphone based 'attentive eating' application. In a feasibility trial of this mobile phone application, adults with overweight or obesity were encouraged to eat attentively by photographing their meals and making satiety ratings after they had eaten. Participants were also required to review what else they had eaten that day before entering their next meal, with an overall aim of encouraging a more attentive eating style. Adherence data and qualitative interviews suggested that the mobile phone app was generally acceptable to participants and easy to use. Participants reported that they felt the application increased their awareness of what they had been eating. There was also an average weight loss of 1.5kg across the 4 week period that participants used the application for. Given that the previous feasibility trial included no control condition, the aim of the current trial was to examine initial proof of concept for effectiveness of an attentive eating smartphone weight loss application.
In the current study the investigators hypothesised that participants randomised to the attentive eating smartphone based condition (experimental condition) would lose significantly more weight than participants randomised to the control condition.
The study is a single centre, parallel, two arm, individually randomised 8 week controlled trial in adults with overweight and obesity in the Merseyside area of England.
- Conditions
- Overweight and Obesity
- Being tested
- Attentive eating smartphone application., Standard dietary advice and text tips.
- Keywords
- attentive eating, e-health, weight loss, food intake
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attentive eating smartphone application.Behavioural
A smartphone application that encourages a more attentive eating style.
Standard dietary advice and text tips.Behavioural
Standard dietary advice for weight loss booklet and weekly text tips containing dietary advice.
| Study group | Role | What they receive |
|---|---|---|
| attentive eating smartphone app group | Experimental | Participant's received the intervention 'Attentive eating smartphone application'. This is a smartphone application that encourages a more attentive eating style. Participants also received the 'Standard dietary advice and text tips' intervention. This consists of a standard dietary advice booklet, and weekly dietary advice tips by text message. Receives: Behavioral: Attentive eating smartphone application.; Behavioral: Standard dietary advice and text tips. |
| control group | Active comparator | Participants received the 'Standard dietary advice and text tips' intervention. This consists of a standard dietary advice booklet, and weekly dietary advice tips by text message. Receives: Behavioral: Standard dietary advice and text tips. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight at 8 weeks.
Weight (kg) measured using Tanita Body composition scales. A lower body weight is considered a better outcome.
Measured: Measured at 8 weeks from the start of the trial.
Self-reported energy intake at 4 weeks.
Energy intake (kcal) measured via 24HR recall. Lower energy intake is considered a better outcome.
Measured: Measured at 4 weeks from the start of the trial.
Self-reported energy intake at 8 weeks.
Energy intake (kcal) measured via 24HR recall. Lower energy intake is considered a better outcome.
Measured: Measured at 8 weeks from the start of the trial.
Objective laboratory measured energy intake at 4 weeks.
Energy intake (kcal) measured with a bogus taste-test task. Lower energy intake is considered a better outcome.
Measured: Measured at 4 weeks from the start of the trial.
Objective laboratory measured energy intake at 8 weeks.
Energy intake (kcal) measured with a bogus taste-test task. Lower energy intake is considered a better outcome.
Measured: Measured at 8 weeks from the start of the trial.
Secondary outcomes (3)
Weight at 4 weeks.
Weight (kg) measured using Tanita Body composition scales. A lower body weight is considered a better outcome.
Measured: Measured at 4 weeks from the start of the trial.
Body fat percentage at 4 weeks.
Body fat percentage measured using Tanita Body composition scales. A lower body fat percentage is considered a better outcome.
Measured: Measured at 4 weeks from the start of the trial.
Body fat percentage at 8 weeks.
Body fat percentage measured using Tanita Body composition scales. A lower body fat percentage is considered a better outcome.
Measured: Measured at 8 weeks from the start of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start7 Sep 2017
- Primary completion11 Apr 2018
- Study completion11 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, University of Oxford
- Responsible party
- Principal investigator, Eric Robinson, University of Liverpool
- Investigators
- Eric Robinson, PhD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602001
- Sponsor's protocol ID
- 1905
- Other IDs
- ES/N00034X/1
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Cappelleri JC, Bushmakin AG, Gerber RA, Leidy NK, Sexton CC, Lowe MR, Karlsson J. Psychometric analysis of the Three-Factor Eating Questionnaire-R21: results from a large diverse sample of obese and non-obese participants. Int J Obes (Lond). 2009 Jun;33(6):611-20. doi: 10.1038/ijo.2009.74. Epub 2009 Apr 28.
PubMed 19399021Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55. doi: 10.1016/0306-4603(82)90024-7.
PubMed 7080884Nijs IM, Franken IH, Muris P. The modified Trait and State Food-Cravings Questionnaires: development and validation of a general index of food craving. Appetite. 2007 Jul;49(1):38-46. doi: 10.1016/j.appet.2006.11.001. Epub 2006 Dec 21.
PubMed 17187897Tylka TL, Kroon Van Diest AM. The Intuitive Eating Scale-2: item refinement and psychometric evaluation with college women and men. J Couns Psychol. 2013 Jan;60(1):137-53. doi: 10.1037/a0030893.
PubMed 23356469Whitelock V, Kersbergen I, Higgs S, Aveyard P, Halford JC, Robinson E. User Experiences of a Smartphone-Based Attentive Eating App and Their Association With Diet and Weight Loss Outcomes: Thematic and Exploratory Analyses From a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Oct 2;8(10):e16780. doi: 10.2196/16780.
PubMed 33006564Whitelock V, Kersbergen I, Higgs S, Aveyard P, Halford JCG, Robinson E. A smartphone based attentive eating intervention for energy intake and weight loss: results from a randomised controlled trial. BMC Public Health. 2019 May 21;19(1):611. doi: 10.1186/s12889-019-6923-x.
PubMed 31113400
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attentive Eating for Weight Loss: Proof of Concept Non-blinded Randomised Control Trial
- ClinicalTrials.gov ID
- NCT03602001
- Acronym / sponsor ID
- 1905
- Conditions
- Overweight and Obesity
- Keywords
- attentive eating, e-health, weight loss, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- University of Birmingham, University of Oxford
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial examined whether a smartphone application designed to encourage a more attentive eating style could help people to lose weight, compared to a control group.
Detailed description
There is evidence that enhancing memory for recent eating and focusing attention on food being consumed influences later energy intake. Studies have shown that attending to food being eaten can reduce food intake. This has since been implemented into a smartphone based 'attentive eating' application. In a feasibility trial of this mobile phone application, adults with overweight or obesity were encouraged to eat attentively by photographing their meals and making satiety ratings after they had eaten. Participants were also required to review what else they had eaten that day before entering their next meal, with an overall aim of encouraging a more attentive eating style. Adherence data and qualitative interviews suggested that the mobile phone app was generally acceptable to participants and easy to use. Participants reported that they felt the application increased their awareness of what they had been eating. There was also an average weight loss of 1.5kg across the 4 week period that participants used the application for. Given that the previous feasibility trial included no control condition, the aim of the current trial was to examine initial proof of concept for effectiveness of an attentive eating smartphone weight loss application.
In the current study the investigators hypothesised that participants randomised to the attentive eating smartphone based condition (experimental condition) would lose significantly more weight than participants randomised to the control condition.
The study is a single centre, parallel, two arm, individually randomised 8 week controlled trial in adults with overweight and obesity in the Merseyside area of England.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| attentive eating smartphone app group | Experimental | Behavioral: Attentive eating smartphone application., Behavioral: Standard dietary advice and text tips.Participant's received the intervention 'Attentive eating smartphone application'. This is a smartphone application that encourages a more attentive eating style. Participants also received the 'Standard dietary advice and text tips' intervention. This consists of a standard dietary advice booklet, and weekly dietary advice tips by text message. |
| control group | Active comparator | Behavioral: Standard dietary advice and text tips.Participants received the 'Standard dietary advice and text tips' intervention. This consists of a standard dietary advice booklet, and weekly dietary advice tips by text message. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI ≥25.0 kg/m2
- Self-report would like to lose weight by changing their dietary behaviour
- 18-65 years
- Fluent English
- Own an Android/Apple smartphone
Key exclusion criteria (5 listed)
- History of eating disorders or food allergies
- Medication that affects appetite
- Pregnant
- Scheduled for weight loss survey during the trial
- Currently on a structured weight loss programme (e.g. Weight Watchers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attentive eating smartphone application.A smartphone application that encourages a more attentive eating style. | Behavioural | attentive eating smartphone app group |
| Standard dietary advice and text tips.Standard dietary advice for weight loss booklet and weekly text tips containing dietary advice. | Behavioural | attentive eating smartphone app group, control group |
Primary outcome
Weight at 8 weeks.
Time frame: Measured at 8 weeks from the start of the trial.
Weight (kg) measured using Tanita Body composition scales. A lower body weight is considered a better outcome.
Self-reported energy intake at 4 weeks.
Time frame: Measured at 4 weeks from the start of the trial.
Energy intake (kcal) measured via 24HR recall. Lower energy intake is considered a better outcome.
Self-reported energy intake at 8 weeks.
Time frame: Measured at 8 weeks from the start of the trial.
Energy intake (kcal) measured via 24HR recall. Lower energy intake is considered a better outcome.
Objective laboratory measured energy intake at 4 weeks.
Time frame: Measured at 4 weeks from the start of the trial.
Energy intake (kcal) measured with a bogus taste-test task. Lower energy intake is considered a better outcome.
Objective laboratory measured energy intake at 8 weeks.
Time frame: Measured at 8 weeks from the start of the trial.
Energy intake (kcal) measured with a bogus taste-test task. Lower energy intake is considered a better outcome.
3 secondary outcomes
Weight at 4 weeks.
Time frame: Measured at 4 weeks from the start of the trial.
Body fat percentage at 4 weeks.
Time frame: Measured at 4 weeks from the start of the trial.
Body fat percentage at 8 weeks.
Time frame: Measured at 8 weeks from the start of the trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Background: PubMed 19399021Cappelleri JC, Bushmakin AG, Gerber RA, Leidy NK, Sexton CC, Lowe MR, Karlsson J. Psychometric analysis of the Three-Factor Eating Questionnaire-R21: results from a large diverse sample of obese and non-obese participants. Int J Obes (Lond). 2009 Jun;33(6):611-20. doi: 10.1038/ijo.2009.74. Epub 2009 Apr 28.
- Background: PubMed 7080884Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55. doi: 10.1016/0306-4603(82)90024-7.
- Background: PubMed 17187897Nijs IM, Franken IH, Muris P. The modified Trait and State Food-Cravings Questionnaires: development and validation of a general index of food craving. Appetite. 2007 Jul;49(1):38-46. doi: 10.1016/j.appet.2006.11.001. Epub 2006 Dec 21.
- Background: PubMed 23356469Tylka TL, Kroon Van Diest AM. The Intuitive Eating Scale-2: item refinement and psychometric evaluation with college women and men. J Couns Psychol. 2013 Jan;60(1):137-53. doi: 10.1037/a0030893.
- Derived from this study: PubMed 33006564Whitelock V, Kersbergen I, Higgs S, Aveyard P, Halford JC, Robinson E. User Experiences of a Smartphone-Based Attentive Eating App and Their Association With Diet and Weight Loss Outcomes: Thematic and Exploratory Analyses From a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Oct 2;8(10):e16780. doi: 10.2196/16780.
- Derived from this study: PubMed 31113400Whitelock V, Kersbergen I, Higgs S, Aveyard P, Halford JCG, Robinson E. A smartphone based attentive eating intervention for energy intake and weight loss: results from a randomised controlled trial. BMC Public Health. 2019 May 21;19(1):611. doi: 10.1186/s12889-019-6923-x.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Robinson, PhD principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attentive eating smartphone application. and Standard dietary advice and text tips. in people with Overweight and Obesity, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight at 8 weeks. (time frame: Measured at 8 weeks from the start of the trial.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03602001, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.