Attentive Eating for Weight Loss

Overweight and Obesity Clinical Trial

Official title:

Attentive Eating for Weight Loss: Proof of Concept Non-blinded Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602001
• Other study ID #: 1905
• Secondary ID: ES/N00034X/1
• Status: Completed
• Phase: N/A
• Start date: September 7, 2017
• Est. completion date: April 11, 2018

Study information

• Verified date: July 2018
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: April 11, 2018
• Est. primary completion date: April 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• Attentive eating smartphone application.
A smartphone application that encourages a more attentive eating style.
• Standard dietary advice and text tips.
Standard dietary advice for weight loss booklet and weekly text tips containing dietary advice.

Locations

Country	Name	City	State
United Kingdom	University of Liverpool	Liverpool	Merseyside

Sponsors (3)

Lead Sponsor	Collaborator
University of Liverpool	University of Birmingham, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View 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. — View 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. Epub 2006 Dec 21. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ideal portion size at 8 weeks.	Assessed using a computer-based visual portion size task, where participants will be asked to indicate their ideal serving size for 18 meals. In this task participants are shown portion size photographs of a meal on the screen, and are asked to use buttons on the keyboard to adjust the portion size. Based on their responses for the 18 meals, participants are assigned a value (in kcals) that represents the average energy content of their ideal portion size.	Measured at 8 weeks from the start of the trial.
Other	Uncontrolled eating measured at 8 weeks.	The Three Factor Eating Questionnaire-21 (Cappelleri et al., 2009) will be used to measure uncontrolled eating. The possible range of scores is 1-4 and higher scores indicate higher levels of uncontrolled eating. A lower score is considered a better outcome.	Measured at 8 weeks from the start of the trial.
Other	Cognitive restraint measured at 8 weeks.	The cognitive restraint sub-scale of the Three Factor Eating Questionnaire-21 will be used to measured cognitive restraint (Cappelleri et al., 2009). The possible range of scores is 1-4 and higher scores indicate higher levels of cognitive restraint. A lower score is considered a better outcome.	Measured at 8 weeks from the start of the trial.
Other	Emotional eating measured at 8 weeks.	The emotional eating sub scale of the Three Factor Eating Questionnaire-21 will be used to measured emotional eating (Cappelleri et al., 2009). The possible range of scores is 1-4 and higher scores indicate higher levels of emotional eating. A lower score is considered a better outcome.	Measured at 8 weeks from the start of the trial.
Other	Binge eating symptoms measured at 8 weeks.	The Binge Eating Scale will be used to measured binge eating symptoms (Gormally, Black, Daston, & Rardin, 1982). The possible range of scores is 0-46 and higher scores indicate a greater number of binge eating symptoms. A lower score is considered a better outcome.	Measured at 8 weeks from the start of the trial.
Other	Food cravings measured at 8 weeks.	Food cravings will be measured using the Food Cravings Questionnaire (Nijs, Franken, & Muris, 2007). The possible range of scores is 21-126 and higher scores indicate a greater food cravings. A lower score is considered a better outcome.	Measured at 8 weeks from the start of the trial.
Other	Intuitive eating measured at 8 weeks.	Intuitive eating will be measured using the reliance on hunger and satiety cues sub-scale of the Intuitive Eating Scale (IES-2; Tylka & Kroon Van Diest, 2013). The possible range of scores is 1-5, and higher scores indicate greater intuitive eating (and greater reliance on hunger and satiety signals). A higher score is considered a better outcome.	Measured at 8 weeks from the start of the trial.
Other	Intervention efficacy beliefs at baseline.	Participants beliefs about how confident they are that the intervention will help them to eat less and lose weight will be measured. The scale consists of 2 questions scored on 100-point visual analogue scales. If responses to both questions are strongly correlated (r = 0.7), the average of the items will be computed to form a single composite measure. The possible score range is 0-100, with higher scores indicating higher beliefs that the intervention will help participants reduce food intake and aid weight loss.	Measured at baseline.
Other	Intervention efficacy beliefs at 8 weeks.	Participants beliefs about how confident they are that the intervention helped them to eat less and lose weight will be measured. The scale consists of 2 questions scored on 100-point visual analogue scales. If responses to both questions are strongly correlated (r = 0.7), the average of the items will be computed to form a single composite measure. The possible score range is 0-100, with higher scores indicating higher beliefs that the intervention helped participants reduce their food intake and lose weight.	Measured at 8 weeks from the start of the trial.
Other	Smartphone application usage.	At 8 week follow-up the researcher will download attentive eating application usage information. This will provide us with information about how often participants used the mobile phone application during the trial (e.g. number of times per day the application was accessed).	Data downloaded at 8 weeks from the start of the trial.
Other	Semi-structured interviews at 8 weeks.	Semi-structured interviews will be conducted with participants in the experimental group during the 8 week follow-up visit, in order to understand participants' experiences of the intervention.	Conducted at 8 weeks from the start of the trial.
Primary	Weight at 8 weeks.	Weight (kg) measured using Tanita Body composition scales. A lower body weight is considered a better outcome.	Measured at 8 weeks from the start of the trial.
Primary	Self-reported energy intake at 4 weeks.	Energy intake (kcal) measured via 24HR recall. Lower energy intake is considered a better outcome.	Measured at 4 weeks from the start of the trial.
Primary	Self-reported energy intake at 8 weeks.	Energy intake (kcal) measured via 24HR recall. Lower energy intake is considered a better outcome.	Measured at 8 weeks from the start of the trial.
Primary	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 at 4 weeks from the start of the trial.
Primary	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 at 8 weeks from the start of the trial.
Secondary	Weight at 4 weeks.	Weight (kg) measured using Tanita Body composition scales. A lower body weight is considered a better outcome.	Measured at 4 weeks from the start of the trial.
Secondary	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 at 4 weeks from the start of the trial.
Secondary	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 at 8 weeks from the start of the trial.