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Attentive Eating for Weight Loss

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Attentive eating smartphone application.
Standard dietary advice and text tips.
Sponsored by
University of Liverpool
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring attentive eating, e-health, weight loss, food intake

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Liverpool

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

attentive eating smartphone app group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Weight at 8 weeks.
Weight (kg) measured using Tanita Body composition scales. A lower body weight is considered a better outcome.
Self-reported energy intake at 4 weeks.
Energy intake (kcal) measured via 24HR recall. Lower energy intake is considered a better outcome.
Self-reported energy intake at 8 weeks.
Energy intake (kcal) measured via 24HR recall. Lower energy intake is considered a better outcome.
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.
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.

Secondary Outcome Measures

Weight at 4 weeks.
Weight (kg) measured using Tanita Body composition scales. A lower body weight is considered a better outcome.
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.
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.

Full Information

First Posted
July 4, 2018
Last Updated
July 26, 2018
Sponsor
University of Liverpool
Collaborators
University of Birmingham, University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT03602001
Brief Title
Attentive Eating for Weight Loss
Official Title
Attentive Eating for Weight Loss: Proof of Concept Non-blinded Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
April 11, 2018 (Actual)
Study Completion Date
April 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liverpool
Collaborators
University of Birmingham, University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
attentive eating, e-health, weight loss, food intake

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
attentive eating smartphone app group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attentive eating smartphone application.
Intervention Description
A smartphone application that encourages a more attentive eating style.
Intervention Type
Behavioral
Intervention Name(s)
Standard dietary advice and text tips.
Intervention Description
Standard dietary advice for weight loss booklet and weekly text tips containing dietary advice.
Primary Outcome Measure Information:
Title
Weight at 8 weeks.
Description
Weight (kg) measured using Tanita Body composition scales. A lower body weight is considered a better outcome.
Time Frame
Measured at 8 weeks from the start of the trial.
Title
Self-reported energy intake at 4 weeks.
Description
Energy intake (kcal) measured via 24HR recall. Lower energy intake is considered a better outcome.
Time Frame
Measured at 4 weeks from the start of the trial.
Title
Self-reported energy intake at 8 weeks.
Description
Energy intake (kcal) measured via 24HR recall. Lower energy intake is considered a better outcome.
Time Frame
Measured at 8 weeks from the start of the trial.
Title
Objective laboratory measured energy intake at 4 weeks.
Description
Energy intake (kcal) measured with a bogus taste-test task. Lower energy intake is considered a better outcome.
Time Frame
Measured at 4 weeks from the start of the trial.
Title
Objective laboratory measured energy intake at 8 weeks.
Description
Energy intake (kcal) measured with a bogus taste-test task. Lower energy intake is considered a better outcome.
Time Frame
Measured at 8 weeks from the start of the trial.
Secondary Outcome Measure Information:
Title
Weight at 4 weeks.
Description
Weight (kg) measured using Tanita Body composition scales. A lower body weight is considered a better outcome.
Time Frame
Measured at 4 weeks from the start of the trial.
Title
Body fat percentage at 4 weeks.
Description
Body fat percentage measured using Tanita Body composition scales. A lower body fat percentage is considered a better outcome.
Time Frame
Measured at 4 weeks from the start of the trial.
Title
Body fat percentage at 8 weeks.
Description
Body fat percentage measured using Tanita Body composition scales. A lower body fat percentage is considered a better outcome.
Time Frame
Measured at 8 weeks from the start of the trial.
Other Pre-specified Outcome Measures:
Title
Ideal portion size at 8 weeks.
Description
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.
Time Frame
Measured at 8 weeks from the start of the trial.
Title
Uncontrolled eating measured at 8 weeks.
Description
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.
Time Frame
Measured at 8 weeks from the start of the trial.
Title
Cognitive restraint measured at 8 weeks.
Description
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.
Time Frame
Measured at 8 weeks from the start of the trial.
Title
Emotional eating measured at 8 weeks.
Description
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.
Time Frame
Measured at 8 weeks from the start of the trial.
Title
Binge eating symptoms measured at 8 weeks.
Description
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.
Time Frame
Measured at 8 weeks from the start of the trial.
Title
Food cravings measured at 8 weeks.
Description
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.
Time Frame
Measured at 8 weeks from the start of the trial.
Title
Intuitive eating measured at 8 weeks.
Description
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.
Time Frame
Measured at 8 weeks from the start of the trial.
Title
Intervention efficacy beliefs at baseline.
Description
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.
Time Frame
Measured at baseline.
Title
Intervention efficacy beliefs at 8 weeks.
Description
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.
Time Frame
Measured at 8 weeks from the start of the trial.
Title
Smartphone application usage.
Description
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).
Time Frame
Data downloaded at 8 weeks from the start of the trial.
Title
Semi-structured interviews at 8 weeks.
Description
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.
Time Frame
Conducted at 8 weeks from the start of the trial.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Robinson, PhD
Organizational Affiliation
University of Liverpool
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Liverpool
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L69 3BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication.
IPD Sharing Time Frame
The study protocol and statistical analysis plan were pre-registered prior to starting recruitment. IPD will be made available shortly prior to publication.
IPD Sharing Access Criteria
The study protocol and statistical analysis plan were pre-registered prior to starting recruitment on the Open Science Framework, these can be accessed via this link. Datafile(s), including IPD, will be made publicly available here also. Link: https://osf.io/btzhw/
IPD Sharing URL
https://osf.io/btzhw/
Citations:
PubMed Identifier
19399021
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.
Results Reference
background
PubMed Identifier
7080884
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.
Results Reference
background
PubMed Identifier
17187897
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.
Results Reference
background
PubMed Identifier
23356469
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.
Results Reference
background
PubMed Identifier
33006564
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.
Results Reference
derived
PubMed Identifier
31113400
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://osf.io/btzhw/
Available IPD/Information Comments
The study protocol was pre-registered prior to starting recruitment on the Open Science Framework and is available via this link. IPD underlying publications will also be available here.

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Attentive Eating for Weight Loss

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