ObesityM-TRIMM2NCT04506996
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
A study testing Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management, Monday-Focused Written Messages for Weight Management and Educational Materials in people with Obesity and Weight Loss, run by Johns Hopkins Bloomberg School of Public Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Obesity, Weight Loss, mHealth
- What is being tested?
- Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management, Monday-Focused Written Messages for Weight Management and Educational Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2016to 27 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 and <71
- BMI > 25
- having a phone that was capable of receiving text-messages and being willing to receive text-messages
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Obesity, Weight Loss, mHealth, Healthy Diet
- Being tested
- Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management, Monday-Focused Written Messages for Weight Management, Educational Materials
- Keywords
- obesity, mHealth, text messages, weight loss intervention, physical activity, diet
- Medical subject headings
- Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight ManagementBehavioural
see arm/group descriptions
Monday-Focused Written Messages for Weight ManagementBehavioural
see arm/group descriptions
Educational MaterialsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Receiving Text Messages | Experimental | 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 Receives: Behavioral: Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management; Behavioral: Educational Materials |
| Control Group - Written Messages | Active comparator | 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. Receives: Behavioral: Monday-Focused Written Messages for Weight Management; Behavioral: Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in weight from baseline
Measured: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
Secondary outcomes (1)
Body Mass Index (BMI) change from baseline
BMI = kg/m2
Measured: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start9 Sep 2016
- Primary completion27 Sep 2018
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, superiority randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Cheskin, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506996
- Sponsor's protocol ID
- 00007115
- Acronym
- M-TRIMM2
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35178432
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
- ClinicalTrials.gov ID
- NCT04506996
- Acronym / sponsor ID
- M-TRIMM2 / 00007115
- Conditions
- Obesity, Weight Loss, mHealth, Healthy Diet
- Keywords
- obesity, mHealth, text messages, weight loss intervention, physical activity, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel, superiority randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Receiving Text Messages | Experimental | Behavioral: Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management, Behavioral: Educational MaterialsThe 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 |
| Control Group - Written Messages | Active comparator | Behavioral: Monday-Focused Written Messages for Weight Management, Behavioral: Educational MaterialsParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 and <71
- BMI > 25
- having a phone that was capable of receiving text-messages and being willing to receive text-messages
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Managementsee arm/group descriptions | Behavioural | Intervention Group - Receiving Text Messages |
| Monday-Focused Written Messages for Weight Managementsee arm/group descriptions | Behavioural | Control Group - Written Messages |
| Educational MaterialsAfter 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 | Behavioural | Control Group - Written Messages, Intervention Group - Receiving Text Messages |
Primary outcome
Percent change in weight from baseline
Time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
1 secondary outcome
Body Mass Index (BMI) change from baseline
Time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Derived from this study: PubMed 35178432Kharmats 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Cheskin, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management, Monday-Focused Written Messages for Weight Management and Educational Materials in people with Obesity and Weight Loss, run by Johns Hopkins Bloomberg School of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in weight from baseline (time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04506996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.