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Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application for Weight Loss

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
"My Meal Mate" (smartphone application)
Paper food diary
Online food diary
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring smartphone, smartphone app, smartphone application, obesity, overweight, self monitoring

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Leeds

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Paper food diary

Online food diary

"My Meal Mate" (smartphone application)

Arm Description

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.

Outcomes

Primary Outcome Measures

Adherence to the trial
The number of completers in each group is a feasibility outcome.
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.

Secondary Outcome Measures

Weight change (kg)
Weight (kg) has been objectively measured at baseline and 6 months.
BMI change
BMI(kg/m2) has been objectively measured at baseline and 6 months.
change in body fat percentage
Body fat (%) has been objectively measured at baseline and 6 months.

Full Information

First Posted
December 5, 2012
Last Updated
December 6, 2012
Sponsor
University of Leeds
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1. Study Identification

Unique Protocol Identification Number
NCT01744535
Brief Title
Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application for Weight Loss
Official Title
Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application Designed to Facilitate Weight Loss.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
smartphone, smartphone app, smartphone application, obesity, overweight, self monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paper food diary
Arm Type
Active Comparator
Arm Title
Online food diary
Arm Type
Active Comparator
Arm Title
"My Meal Mate" (smartphone application)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
"My Meal Mate" (smartphone application)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Paper food diary
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online food diary
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to the trial
Description
The number of completers in each group is a feasibility outcome.
Time Frame
6 months
Title
Adherence to the intervention arms
Description
The number of days with a plausible record of diet (>500-5000 kcal recorded) in each arm is a feasibility outcome.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Weight change (kg)
Description
Weight (kg) has been objectively measured at baseline and 6 months.
Time Frame
6 months
Title
BMI change
Description
BMI(kg/m2) has been objectively measured at baseline and 6 months.
Time Frame
6 months
Title
change in body fat percentage
Description
Body fat (%) has been objectively measured at baseline and 6 months.
Time Frame
6 months

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: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Cade, Professor
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leeds
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS29JT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22717334
Citation
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.
Results Reference
background
PubMed Identifier
28153814
Citation
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.
Results Reference
derived
PubMed Identifier
23587561
Citation
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.
Results Reference
derived

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Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application for Weight Loss

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