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

Obesity Clinical Trial

— M-TRIMM2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506996
• Other study ID #: 00007115
• Status: Completed
• Phase: N/A
• Start date: September 9, 2016
• Est. completion date: September 27, 2018

Study information

• Verified date: August 2020
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: September 27, 2018
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Healthy Diet
• mHealth
• Obesity
• Weight Loss

Intervention

Behavioral:
• Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management
see arm/group descriptions
• Monday-Focused Written Messages for Weight Management
see arm/group descriptions
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Percent change in weight from baseline		~8 weeks, ~16 weeks, and ~42 weeks post-randomization
Secondary	Body Mass Index (BMI) change from baseline	BMI = kg/m2	~8 weeks, ~16 weeks, and ~42 weeks post-randomization