Clinical trial NCT04506996: Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
Official title: Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
mHealth
Healthy Diet
Keywords: obesity
mHealth
text messages
weight loss intervention
physical activity
diet
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel, superiority randomized controlled trial
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Percent change in weight from baseline
timeFrame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
Secondary outcomes:
measure: Body Mass Index (BMI) change from baseline
timeFrame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
Other outcomes:
measure: Change from baseline in self-efficacy to lose weight
timeFrame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
measure: Physical activity change from baseline
timeFrame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
measure: Change from baseline in fruit and vegetable servings intake from baseline
timeFrame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
measure: Change from baseline in percent energy from fat intake
timeFrame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
measure: Change from baseline in scores of perceived exercise benefits and barriers to engaging in exercise and physical activity
timeFrame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
measure: Comparison of satisfaction with the program and suggestions for improvement between intervention and control groups
timeFrame: ~16 weeks, and ~42 weeks post-randomization compared to baseline
Locations:
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Lawrence Cheskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.