Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 (M-TRIMM2)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; mHealth; Healthy Diet
• Intervention / Treatment: Behavioral: Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management; Behavioral: Educational Materials; Behavioral: Monday-Focused Written Messages for Weight Management

Detailed Description

The specific aims of this research project are to:

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

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group - Receiving Text Messages; 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; see arm/group descriptions; Behavioral: Educational Materials; 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
Active Comparator: Control Group - Written Messages; 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: Educational Materials; 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; Behavioral: Monday-Focused Written Messages for Weight Management; see arm/group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in self-efficacy to lose weight	Weight Efficacy Lifestyle Questionnaire (Clark, Abrams,& Niaura, 1991)	~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
Physical activity change from baseline	International Physical Activity Questionnaire - was used to calculate the total metabolic equivalents (MET)-minutes per week, and MET-minutes per week for four domains of physical activity: (1) PA activity performed at work or during volunteer activities, (2) transportation-related PA (such as walking to do errands), (3) PA performed during housework and caring for family, and (4) recreational, sport, and leisure-time PA.	~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
Change from baseline in fruit and vegetable servings intake from baseline	National Cancer Institute's (NCI) 19-item All -Day Fruit and Vegetable Screener was used to calculate daily averages of fruit and vegetable serving intake, using NCI's 2001 scoring protocol.	~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
Change from baseline in percent energy from fat intake	National Cancer Institute's 17-item Percent Energy from Fat Screener - All-Day Quick Food Scan was used and scored according to NCI's 2004 protocol.	~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
Change from baseline in scores of perceived exercise benefits and barriers to engaging in exercise and physical activity	The 43-item Exercise Benefits and Barriers Scale was used. Separate scores will be calculated for perceived benefits and for perceived barriers. (Sechrist, Walker, & Pender, 1987)	~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
Comparison of satisfaction with the program and suggestions for improvement between intervention and control groups	Participants completed a questionnaire that included quantitative and qualitative questions. Most of the qualitative questions sought to assess what parts of the program worked well and what could have been done better. For instance, participants were asked for their suggestions about what could be done to improve the M-TRIMM2 program, what messages they liked and did not like, and why they would or would not recommend the program to their friends. The quantitative questions covered a variety of topics, including participants engagement with the program (i.e. whether the participants read the messages they received), how useful messages were in helping participants reach the eight study goals (i.e. eating only when hungry, and exercising more), how helpful the goals were helping participants to achieve weight loss, and whether the program helped participants commit to new goals each Monday during the intervention.	~16 weeks, and ~42 weeks post-randomization compared to baseline

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Investigators: Principal Investigator: Lawrence Cheskin, MD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

General Publications

• Kharmats AY, Wang C, Fuentes L, Hu L, Kline T, Welding K, Cheskin LJ. Monday-focused tailored rapid interactive mobile messaging for weight management 2 (MTRIMM2): results from a randomized controlled trial. Mhealth. 2022 Jan 20;8:1. doi: 10.21037/mhealth-21-3. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2016
• Primary Completion (Actual): September 27, 2018
• Study Completion (Actual): September 27, 2018

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: physical activity; obesity; mHealth; text messages; diet; weight loss intervention
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 00007115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No