NCT03602001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

July 4, 2018

Last Update Submit

July 26, 2018

Conditions

Overweight and Obesity

Keywords

attentive eatinge-healthweight lossfood intake

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (3)

  • Weight at 4 weeks.

    Measured at 4 weeks from the start of the trial.

  • Body fat percentage at 4 weeks.

    Measured at 4 weeks from the start of the trial.

  • Body fat percentage at 8 weeks.

    Measured at 8 weeks from the start of the trial.

Other Outcomes (11)

  • Ideal portion size at 8 weeks.

    Measured at 8 weeks from the start of the trial.

  • Uncontrolled eating measured at 8 weeks.

    Measured at 8 weeks from the start of the trial.

  • Cognitive restraint measured at 8 weeks.

    Measured at 8 weeks from the start of the trial.

  • +8 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Standard dietary advice and text tips.

Interventions

Attentive eating smartphone application.BEHAVIORAL

A smartphone application that encourages a more attentive eating style.

attentive eating smartphone app group
Standard dietary advice and text tips.BEHAVIORAL

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

attentive eating smartphone app groupcontrol group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥25.0 kg/m2
  • Self-report would like to lose weight by changing their dietary behaviour
  • years
  • Fluent English
  • Own an Android/Apple smartphone

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liverpool

Liverpool, Merseyside, L69 3BX, United Kingdom

Location

Related Publications (6)

  • 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.

    PMID: 19399021BACKGROUND

  • 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.

    PMID: 7080884BACKGROUND

  • 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.

    PMID: 17187897BACKGROUND

  • 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.

    PMID: 23356469BACKGROUND

  • 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.

    PMID: 33006564DERIVED

  • 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.

    PMID: 31113400DERIVED

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Eric Robinson, PhD

    University of Liverpool

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 4, 2018

First Posted

July 26, 2018

Study Start

September 7, 2017

Primary Completion

April 11, 2018

Study Completion

April 11, 2018

Last Updated

July 30, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, 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/
More information

Available IPD Datasets

Study Protocol Access

Locations

GB(1)