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Attentive Eating for Weight Loss

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ClinicalTrials.gov Identifier: NCT03602001
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : July 30, 2018
Sponsor:
Collaborators:
University of Birmingham
University of Oxford
Information provided by (Responsible Party):
Eric Robinson, University of Liverpool

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Attentive eating smartphone application. Behavioral: Standard dietary advice and text tips. Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Attentive Eating for Weight Loss: Proof of Concept Non-blinded Randomised Control Trial
Actual Study Start Date : September 7, 2017
Actual Primary Completion Date : April 11, 2018
Actual Study Completion Date : April 11, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: attentive eating smartphone app group
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.
Behavioral: Attentive eating smartphone application.
A smartphone application that encourages a more attentive eating style.

Behavioral: Standard dietary advice and text tips.
Standard dietary advice for weight loss booklet and weekly text tips containing dietary advice.

Active Comparator: control group
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.
Behavioral: Standard dietary advice and text tips.
Standard dietary advice for weight loss booklet and weekly text tips containing dietary advice.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Weight at 4 weeks. [ Time Frame: Measured at 4 weeks from the start of the trial. ]
    Weight (kg) measured using Tanita Body composition scales. A lower body weight is considered a better outcome.

  2. Body fat percentage at 4 weeks. [ Time Frame: Measured at 4 weeks from the start of the trial. ]
    Body fat percentage measured using Tanita Body composition scales. A lower body fat percentage is considered a better outcome.

  3. Body fat percentage at 8 weeks. [ Time Frame: Measured at 8 weeks from the start of the trial. ]
    Body fat percentage measured using Tanita Body composition scales. A lower body fat percentage is considered a better outcome.


Other Outcome Measures:
  1. Ideal portion size at 8 weeks. [ Time Frame: Measured at 8 weeks from the start of the trial. ]
    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.

  2. Uncontrolled eating measured at 8 weeks. [ Time Frame: Measured at 8 weeks from the start of the trial. ]
    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.

  3. Cognitive restraint measured at 8 weeks. [ Time Frame: Measured at 8 weeks from the start of the trial. ]
    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.

  4. Emotional eating measured at 8 weeks. [ Time Frame: Measured at 8 weeks from the start of the trial. ]
    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.

  5. Binge eating symptoms measured at 8 weeks. [ Time Frame: Measured at 8 weeks from the start of the trial. ]
    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.

  6. Food cravings measured at 8 weeks. [ Time Frame: Measured at 8 weeks from the start of the trial. ]
    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.

  7. Intuitive eating measured at 8 weeks. [ Time Frame: Measured at 8 weeks from the start of the trial. ]
    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.

  8. Intervention efficacy beliefs at baseline. [ Time Frame: Measured 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.

  9. Intervention efficacy beliefs at 8 weeks. [ Time Frame: Measured at 8 weeks from the start of the trial. ]
    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.

  10. Smartphone application usage. [ Time Frame: Data downloaded at 8 weeks from the start of the trial. ]
    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).

  11. Semi-structured interviews at 8 weeks. [ Time Frame: Conducted at 8 weeks from the start of the trial. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602001


Locations
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United Kingdom
University of Liverpool
Liverpool, Merseyside, United Kingdom, L69 3BX
Sponsors and Collaborators
University of Liverpool
University of Birmingham
University of Oxford
Investigators
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Principal Investigator: Eric Robinson, PhD University of Liverpool

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
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.

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eric Robinson, Principle Investigator, University of Liverpool
ClinicalTrials.gov Identifier: NCT03602001     History of Changes
Other Study ID Numbers: 1905
ES/N00034X/1 ( Other Grant/Funding Number: ESRC )
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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/
URL: https://osf.io/btzhw/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Robinson, University of Liverpool:
attentive eating
e-health
weight loss
food intake
Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes