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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Trial of My Meal Mate (MMM), a Smartphone Application Designed to Facilitate Weight Loss.

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: My Meal Mate (smartphone application)
* Behavioral: Paper food diary
* Behavioral: Online food diary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paper food diary<br> | Behavioral: Paper food diary<br>* 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.<br>|
| Active Comparator: Online food diary<br> | Behavioral: Online food diary<br>* 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.<br>|
| Experimental: My Meal Mate (smartphone application)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change (kg) | Weight (kg) has been objectively measured at baseline and 6 months. | 6 months | 
| BMI change | BMI(kg/m2) has been objectively measured at baseline and 6 months. | 6 months | 
| change in body fat percentage | Body fat (%) has been objectively measured at baseline and 6 months. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smartphone, smartphone app, smartphone application, obesity, overweight, self monitoring