NCT01744535

Brief Summary

The aim of this study is to implement an exploratory pilot trial of "My Meal Mate" (MMM), a smartphone application developed to facilitate weight loss, assessing its feasibility and acceptability. Overweight and obese adults will be recruited from large employers within the local area. The trial will aim to recruit a sample size of 135 which is a pragmatic decision based on randomizing 45 people to each arm. Participants will be randomized to one of three groups. The researchers have developed a smartphone application for weight loss called "My Meal Mate" (MMM) which incorporates a large branded food and drink database. MMM was developed using focus group data collected from potential system users and by benchmarking with similar commercially available diet tracking applications. One group will receive a smartphone with the MMM app downloaded on it, one group will receive access to an online food diary and one group will be given a paper food diary. Participants will be asked to set a goal for weight loss and self-monitor their food intake and activity using their allocated study equipment. Participants will be weighed at the beginning of the trial, at 6 weeks and at 6 months. Feasibility and acceptability outcomes will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2 obesity

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

March 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
Last Updated

December 7, 2012

Status Verified

December 1, 2012

Enrollment Period

10 months

First QC Date

December 5, 2012

Last Update Submit

December 6, 2012

Conditions

ObesityOverweight

Keywords

smartphonesmartphone appsmartphone applicationobesityoverweightself monitoring

Outcome Measures

Primary Outcomes (2)

  • Adherence to the trial

    The number of completers in each group is a feasibility outcome.

    6 months

  • Adherence to the intervention arms

    The number of days with a plausible record of diet (\>500-5000 kcal recorded) in each arm is a feasibility outcome.

    6 months

Secondary Outcomes (3)

  • Weight change (kg)

    6 months

  • BMI change

    6 months

  • change in body fat percentage

    6 months

Study Arms (3)

Paper food diary

ACTIVE COMPARATOR
Behavioral: Paper food diary

Online food diary

ACTIVE COMPARATOR
Behavioral: Online food diary

"My Meal Mate" (smartphone application)

EXPERIMENTAL

A smartphone application called "My Meal Mate" (MMM) designed to facilitate weight loss. The app allows system users to set a goal for weight loss and self monitor diet and activity in an electronic diary. Users can select foods from the large "Weight Loss Resources" food database. Instant nutritional feedback is provided along with weekly feedback by text message.

Behavioral: "My Meal Mate" (smartphone application)

Interventions

"My Meal Mate" (smartphone application)BEHAVIORAL

A smartphone application called "My Meal Mate" (MMM) designed to facilitate weight loss. The app allows system users to set a goal for weight loss and self monitor diet and activity in an electronic diary. Users receive instant nutritional feedback and feedback via text message.

"My Meal Mate" (smartphone application)
Paper food diaryBEHAVIORAL

The paper food diary is provided by a commerical slimming organisation called "Weight Loss Resources". The diary allows the user to record daily food and drink consumed. It is accompanied by a book which provides a database of the nutritional content of 40,000 food and drinks. The diary also encourages participants to record their physical activity.

Paper food diary
Online food diaryBEHAVIORAL

The online food diary is provided by a commerical slimming organisation called "Weight Loss Resources". The electronic diary allows the user to record daily food and drink consumed. System users are also encouraged to record their physical activity.

Online food diary

Eligibility Criteria

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

You may qualify if:

  • Aged 18-65
  • BMI equal to or greater than 27 kg/m2
  • Willing to commit the necessary time and effort to the study,
  • Employed by a large employer in Leeds (and expects to continue to be employed there for the next 12 months),
  • Able to read and write in English,
  • Able to access the internet,
  • Willing to be randomised to one of three groups.

You may not qualify if:

  • Pregnant, planning a pregnancy within next 12 months, lactating
  • Has had surgery for weight loss
  • Taking the medication sertraline (due to associations with weight gain)
  • Taking anti-obesity medications or medications for diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS29JT, United Kingdom

Location

Related Publications (4)

  • Carter MC, Burley VJ, Nykjaer C, Cade JE. 'My Meal Mate' (MMM): validation of the diet measures captured on a smartphone application to facilitate weight loss. Br J Nutr. 2013 Feb 14;109(3):539-46. doi: 10.1017/S0007114512001353. Epub 2012 May 3.

    PMID: 22717334BACKGROUND

  • Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

    PMID: 38375882DERIVED

  • Carter MC, Burley VJ, Cade JE. Weight Loss Associated With Different Patterns of Self-Monitoring Using the Mobile Phone App My Meal Mate. JMIR Mhealth Uhealth. 2017 Feb 2;5(2):e8. doi: 10.2196/mhealth.4520.

    PMID: 28153814DERIVED

  • Carter MC, Burley VJ, Nykjaer C, Cade JE. Adherence to a smartphone application for weight loss compared to website and paper diary: pilot randomized controlled trial. J Med Internet Res. 2013 Apr 15;15(4):e32. doi: 10.2196/jmir.2283.

    PMID: 23587561DERIVED

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janet Cade, Professor

    University of Leeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Dietitian

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 6, 2012

Study Start

March 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 7, 2012

Record last verified: 2012-12

Locations

GB(1)