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Completed

NCT Number: NCT04506996

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

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.

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Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Healthy Diet Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss mHealth

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management

Behavioral

see arm/group descriptions

Monday-Focused Written Messages for Weight Management

Behavioral

see arm/group descriptions

Educational materials

Behavioral

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 outcomes

  1. Percent change in weight from baseline

    Time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization

Secondary outcomes

  1. Body Mass Index (BMI) change from baseline

    Time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization

    BMI = kg/m2

Other outcomes

  1. Change from baseline in self-efficacy to lose weight

    Time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline

    Weight Efficacy Lifestyle Questionnaire (Clark, Abrams,& Niaura, 1991)

  2. Physical activity change from baseline

    Time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to 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.

  3. 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

    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.

  4. Change from baseline in percent energy from fat intake

    Time frame: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline

    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.

  5. 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

    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)

  6. 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

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Registry information

Acronym: M-TRIMM2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2020
Registry last updated
Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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