<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04506996</url>
  </required_header>
  <id_info>
    <org_study_id>00007115</org_study_id>
    <nct_id>NCT04506996</nct_id>
  </id_info>
  <brief_title>Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2</brief_title>
  <acronym>M-TRIMM2</acronym>
  <official_title>Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study, involves the implementation and evaluation of a Monday-focused, individually&#xD;
      tailored mobile health application to assist overweight or obese adults who would like to&#xD;
      achieve a healthful weight. The goal was to evaluate the application of a Monday-focused&#xD;
      delivery system for the M-TRIMM2 intervention on participants who worked or lived in areas in&#xD;
      or adjacent to Johns Hopkins East Baltimore medical campus.Targeting mobile messaging&#xD;
      occurred at strategic intervals throughout each week, with the intent of prompting&#xD;
      participants to renew their health resolutions each Monday combined with lifestyle behavioral&#xD;
      education.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific aims of this research project are to:&#xD;
&#xD;
        1. Develop a targeted delivery system for mobile health messages which focused on improving&#xD;
           physical activity and diet, and setting healthy resolutions each week.&#xD;
&#xD;
        2. Deliver the M-TRIMM intervention, which encourages healthy behavior and the weekly&#xD;
           renewal of health resolutions.&#xD;
&#xD;
        3. Evaluate the effectiveness of this intervention on individuals' weight loss,&#xD;
           self-efficacy, and motivation to sustain changes in lifestyle behaviors.&#xD;
&#xD;
        4. Assess the benefit of receiving the message content only (in a paper document), versus a&#xD;
           scheduled weekly delivery via mobile messaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2016</start_date>
  <completion_date type="Actual">September 27, 2018</completion_date>
  <primary_completion_date type="Actual">September 27, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel, superiority randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change in weight from baseline</measure>
    <time_frame>~8 weeks, ~16 weeks, and ~42 weeks post-randomization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI) change from baseline</measure>
    <time_frame>~8 weeks, ~16 weeks, and ~42 weeks post-randomization</time_frame>
    <description>BMI = kg/m2</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in self-efficacy to lose weight</measure>
    <time_frame>~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline</time_frame>
    <description>Weight Efficacy Lifestyle Questionnaire (Clark, Abrams,&amp; Niaura, 1991)</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity change from baseline</measure>
    <time_frame>~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in fruit and vegetable servings intake from baseline</measure>
    <time_frame>~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in percent energy from fat intake</measure>
    <time_frame>~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in scores of perceived exercise benefits and barriers to engaging in exercise and physical activity</measure>
    <time_frame>~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline</time_frame>
    <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, &amp; Pender, 1987)</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparison of satisfaction with the program and suggestions for improvement between intervention and control groups</measure>
    <time_frame>~16 weeks, and ~42 weeks post-randomization compared to baseline</time_frame>
    <description>Participants completed a questionnaire that included quantitative and qualitative questions.&#xD;
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.&#xD;
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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Loss</condition>
  <condition>mHealth</condition>
  <condition>Healthy Diet</condition>
  <arm_group>
    <arm_group_label>Intervention Group - Receiving Text Messages</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
Messaging&#xD;
Sun evening: asked to pick 1 of 3 goal topics&#xD;
Mon morning: received a goal to focus on for the week&#xD;
Mon evening: asked whether plans were made to reach the goal&#xD;
Wed morning: received a tip to help reach goal&#xD;
Wed evening: reminded that if having cravings, text &quot;tip&quot; to automatically receive a tip&#xD;
Fri morning: received end of the week congratulations, encouragement to keep goals in mind over the weekend&#xD;
Fri evening: asked for weight, congratulated if lost weight, or encouraged if no weight lost</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group - Written Messages</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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).&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management</intervention_name>
    <description>see arm/group descriptions</description>
    <arm_group_label>Intervention Group - Receiving Text Messages</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Monday-Focused Written Messages for Weight Management</intervention_name>
    <description>see arm/group descriptions</description>
    <arm_group_label>Control Group - Written Messages</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational Materials</intervention_name>
    <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</description>
    <arm_group_label>Control Group - Written Messages</arm_group_label>
    <arm_group_label>Intervention Group - Receiving Text Messages</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 and &lt;71&#xD;
&#xD;
          -  BMI &gt; 25&#xD;
&#xD;
          -  having a phone that was capable of receiving text-messages and being willing to&#xD;
             receive text-messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 or ≥ 71&#xD;
&#xD;
          -  BMI ≤ 25&#xD;
&#xD;
          -  not having a phone that was capable of receiving text-messages or not being willing to&#xD;
             receive text-messages&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lawrence Cheskin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>mHealth</keyword>
  <keyword>text messages</keyword>
  <keyword>weight loss intervention</keyword>
  <keyword>physical activity</keyword>
  <keyword>diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04506996
org study id: 00007115
nct id: NCT04506996
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel, superiority randomized controlled trial
primary purpose: Treatment
masking: Single (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.
measure: Percent change in weight from baseline
time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
measure: Body Mass Index (BMI) change from baseline
time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
description: BMI = kg/m2
measure: Change from baseline in self-efficacy to lose weight
time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
description: Weight Efficacy Lifestyle Questionnaire (Clark, Abrams,& Niaura, 1991)
measure: Physical activity change from baseline
time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to 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.
measure: Change from baseline in fruit and vegetable servings intake from baseline
time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to 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.
measure: Change from baseline in percent energy from fat intake
time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
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.
measure: Change from baseline in scores of perceived exercise benefits and barriers to engaging in exercise and physical activity
time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
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)
measure: Comparison of satisfaction with the program and suggestions for improvement between intervention and control groups
time frame: ~16 weeks, and ~42 weeks post-randomization compared to baseline
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.
arm group label: Intervention Group - Receiving Text Messages
arm group type: Experimental
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 group label: Control Group - Written Messages
arm group type: Active Comparator
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: Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management
description: see arm/group descriptions
arm group label: Intervention Group - Receiving Text Messages
intervention type: Behavioral
intervention name: Monday-Focused Written Messages for Weight Management
description: see arm/group descriptions
arm group label: Control Group - Written Messages
intervention type: Behavioral
intervention name: Educational Materials
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
arm group label: Control Group - Written Messages
arm group label: Intervention Group - Receiving Text Messages
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Lawrence Cheskin, MD
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
responsible party type: Sponsor
mesh term: Body Weight
mesh term: Weight Loss
sharing ipd: No