Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2

Study Overview
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Brief Summary
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This study, involves the implementation and evaluation of a Monday-focused, individually tailored mobile health application to assist overweight or obese adults who would like to achieve a healthful weight. The goal was to evaluate the application of a Monday-focused delivery system for the M-TRIMM2 intervention on participants who worked or lived in areas in or adjacent to Johns Hopkins East Baltimore medical campus.Targeting mobile messaging occurred at strategic intervals throughout each week, with the intent of prompting participants to renew their health resolutions each Monday combined with lifestyle behavioral education.

Detailed Description
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The specific aims of this research project are to: Develop a targeted delivery system for mobile health messages which focused on improving physical activity and diet, and setting healthy resolutions each week. Deliver the M-TRIMM intervention, which encourages healthy behavior and the weekly renewal of health resolutions. Evaluate the effectiveness of this intervention on individuals' weight loss, self-efficacy, and motivation to sustain changes in lifestyle behaviors. Assess the benefit of receiving the message content only (in a paper document), versus a scheduled weekly delivery via mobile messaging.

Official Title
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Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2

Conditions
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Obesity, Weight Loss, mHealth, Healthy Diet

Intervention / Treatment
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* Behavioral: Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management
* Behavioral: Monday-Focused Written Messages for Weight Management
* Behavioral: Educational Materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 and <71 BMI > 25 having a phone that was capable of receiving text-messages and being willing to receive text-messages Exclusion Criteria: age <18 or ≥ 71 BMI ≤ 25 not having a phone that was capable of receiving text-messages or not being willing to receive text-messages

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Parallel, superiority randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group - Receiving Text Messages<br>The 16-weeks text-messaging intervention centered around 8 goal topics: eating only when hungry, increasing PA, eating a lower fat diet, eating less sugar and reducing calories from beverages, exercising more, eating a balance diet, portion control, and making healthier food choices in social situations. Messaging Sun evening: asked to pick 1 of 3 goal topics Mon morning: received a goal to focus on for the week Mon evening: asked whether plans were made to reach the goal Wed morning: received a tip to help reach goal Wed evening: reminded that if having cravings, text tip to automatically receive a tip Fri morning: received end of the week congratulations, encouragement to keep goals in mind over the weekend Fri evening: asked for weight, congratulated if lost weight, or encouraged if no weight lost | Behavioral: Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management<br>* see arm/group descriptions<br>Behavioral: Educational Materials<br>* After the baseline assessment and the 1st follow-up ( 8 weeks post randomization), participants received educational materials regarding physical activity and healthier diets. The study staff reviewed these materials with the participants<br>|
| Active Comparator: Control Group - Written Messages<br>Participants in the control group, received a printed copy of the same messages that the intervention group received. However, the first eight-weeks' worth of messages and craving tips were given after the baseline assessment, and the rest were given after the first follow-up assessment (  8 weeks post randomization). The messages for each week were clearly laid out and labeled. Participants were given spaces to record their answers (i.e. to which goal they were selecting for each week). The study staff reviewed the first week's messages together with the study participants to get the participants comfortable with the format that the printed messages were presented in. | Behavioral: Monday-Focused Written Messages for Weight Management<br>* see arm/group descriptions<br>Behavioral: Educational Materials<br>* After the baseline assessment and the 1st follow-up ( 8 weeks post randomization), participants received educational materials regarding physical activity and healthier diets. The study staff reviewed these materials with the participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in weight from baseline |  |  8 weeks,  16 weeks, and  42 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) change from baseline | BMI = kg/m2 |  8 weeks,  16 weeks, and  42 weeks post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, mHealth, text messages, weight loss intervention, physical activity, diet