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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle Carter, University of Leeds
ClinicalTrials.gov Identifier:
NCT01744535
First received: December 5, 2012
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Obesity
Overweight
Behavioral: "My Meal Mate" (smartphone application)
Behavioral: Paper food diary
Behavioral: Online food diary
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application Designed to Facilitate Weight Loss.

Resource links provided by NLM:


Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • Adherence to the trial [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The number of completers in each group is a feasibility outcome.

  • Adherence to the intervention arms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Weight (kg) has been objectively measured at baseline and 6 months.

  • BMI change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    BMI(kg/m2) has been objectively measured at baseline and 6 months.

  • change in body fat percentage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body fat (%) has been objectively measured at baseline and 6 months.


Enrollment: 128
Study Start Date: March 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paper food diary Behavioral: Paper food diary
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.
Active Comparator: Online food diary Behavioral: Online food diary
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.
Experimental: "My Meal Mate" (smartphone application)
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744535

Locations
United Kingdom
University of Leeds
Leeds, West Yorkshire, United Kingdom, LS29JT
Sponsors and Collaborators
University of Leeds
Investigators
Principal Investigator: Janet Cade, Professor University of Leeds
  More Information

Publications:
Responsible Party: Michelle Carter, Research Dietitian, University of Leeds
ClinicalTrials.gov Identifier: NCT01744535     History of Changes
Other Study ID Numbers: G0802108
Study First Received: December 5, 2012
Last Updated: December 6, 2012
Health Authority: United Kingdom: Research Councils UK

Keywords provided by University of Leeds:
smartphone
smartphone app
smartphone application
obesity
overweight
self monitoring

Additional relevant MeSH terms:
Obesity
Weight Loss
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 28, 2014