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

Primary Purpose

Obesity, Weight Loss, mHealth

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management
Monday-Focused Written Messages for Weight Management
Educational Materials
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, mHealth, text messages, weight loss intervention, physical activity, diet

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention Group - Receiving Text Messages

    Control Group - Written Messages

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    Percent change in weight from baseline

    Secondary Outcome Measures

    Body Mass Index (BMI) change from baseline
    BMI = kg/m2

    Full Information

    First Posted
    August 7, 2020
    Last Updated
    August 7, 2020
    Sponsor
    Johns Hopkins Bloomberg School of Public Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04506996
    Brief Title
    Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
    Acronym
    M-TRIMM2
    Official Title
    Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 9, 2016 (Actual)
    Primary Completion Date
    September 27, 2018 (Actual)
    Study Completion Date
    September 27, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins Bloomberg School of Public Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Weight Loss, mHealth, Healthy Diet
    Keywords
    obesity, mHealth, text messages, weight loss intervention, physical activity, diet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel, superiority randomized controlled trial
    Masking
    Investigator
    Masking Description
    Participants were randomized after they completed the study's baseline assessment. The randomization sequence was designed to balance treatment groups by gender of the participants. Allocation was concealed from the data collectors, and was determined using a randomization module in REDCap, a survey website. The data collectors were not blinded to the randomization results after the completion of the baseline survey.
    Allocation
    Randomized
    Enrollment
    154 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group - Receiving Text Messages
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control Group - Written Messages
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management
    Intervention Description
    see arm/group descriptions
    Intervention Type
    Behavioral
    Intervention Name(s)
    Monday-Focused Written Messages for Weight Management
    Intervention Description
    see arm/group descriptions
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational Materials
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Percent change in weight from baseline
    Time Frame
    ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
    Secondary Outcome Measure Information:
    Title
    Body Mass Index (BMI) change from baseline
    Description
    BMI = kg/m2
    Time Frame
    ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
    Other Pre-specified Outcome Measures:
    Title
    Change from baseline in self-efficacy to lose weight
    Description
    Weight Efficacy Lifestyle Questionnaire (Clark, Abrams,& Niaura, 1991)
    Time Frame
    ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
    Title
    Physical activity change from baseline
    Description
    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.
    Time Frame
    ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
    Title
    Change from baseline in fruit and vegetable servings intake from baseline
    Description
    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.
    Time Frame
    ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
    Title
    Change from baseline in percent energy from fat intake
    Description
    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.
    Time Frame
    ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
    Title
    Change from baseline in scores of perceived exercise benefits and barriers to engaging in exercise and physical activity
    Description
    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)
    Time Frame
    ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
    Title
    Comparison of satisfaction with the program and suggestions for improvement between intervention and control groups
    Description
    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.
    Time Frame
    ~16 weeks, and ~42 weeks post-randomization compared to baseline

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lawrence Cheskin, MD
    Organizational Affiliation
    Johns Hopkins Bloomberg School of Public Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35178432
    Citation
    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.
    Results Reference
    derived

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

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