Clinical trial NCT03602001: Attentive Eating for Weight Loss
Official title: Attentive Eating for Weight Loss: Proof of Concept Non-blinded Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: attentive eating
e-health
weight loss
food intake
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: University of Birmingham
name: University of Oxford
First posted: 2018-07-26
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Weight at 8 weeks.
timeFrame: Measured at 8 weeks from the start of the trial.
measure: Self-reported energy intake at 4 weeks.
timeFrame: Measured at 4 weeks from the start of the trial.
measure: Self-reported energy intake at 8 weeks.
timeFrame: Measured at 8 weeks from the start of the trial.
measure: Objective laboratory measured energy intake at 4 weeks.
timeFrame: Measured at 4 weeks from the start of the trial.
measure: Objective laboratory measured energy intake at 8 weeks.
timeFrame: Measured at 8 weeks from the start of the trial.
Secondary outcomes:
measure: Weight at 4 weeks.
timeFrame: Measured at 4 weeks from the start of the trial.
measure: Body fat percentage at 4 weeks.
timeFrame: Measured at 4 weeks from the start of the trial.
measure: Body fat percentage at 8 weeks.
timeFrame: Measured at 8 weeks from the start of the trial.
Other outcomes:
measure: Ideal portion size at 8 weeks.
timeFrame: Measured at 8 weeks from the start of the trial.
measure: Uncontrolled eating measured at 8 weeks.
timeFrame: Measured at 8 weeks from the start of the trial.
measure: Cognitive restraint measured at 8 weeks.
timeFrame: Measured at 8 weeks from the start of the trial.
measure: Emotional eating measured at 8 weeks.
timeFrame: Measured at 8 weeks from the start of the trial.
measure: Binge eating symptoms measured at 8 weeks.
timeFrame: Measured at 8 weeks from the start of the trial.
measure: Food cravings measured at 8 weeks.
timeFrame: Measured at 8 weeks from the start of the trial.
measure: Intuitive eating measured at 8 weeks.
timeFrame: Measured at 8 weeks from the start of the trial.
measure: Intervention efficacy beliefs at baseline.
timeFrame: Measured at baseline.
measure: Intervention efficacy beliefs at 8 weeks.
timeFrame: Measured at 8 weeks from the start of the trial.
measure: Smartphone application usage.
timeFrame: Data downloaded at 8 weeks from the start of the trial.
measure: Semi-structured interviews at 8 weeks.
timeFrame: Conducted at 8 weeks from the start of the trial.
Locations:
city: Liverpool
country: United Kingdom
facility: University of Liverpool
state: Merseyside
Study officials:
affiliation: University of Liverpool
name: Eric Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Gormally 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.
citation: Nijs 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.
citation: Tylka 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.
citation: Whitelock 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.
citation: Whitelock 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.