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Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 (M-TRIMM2)

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

154

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention Group - Receiving Text Messages

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

see arm/group descriptions
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
Comparatore attivo: Control Group - Written Messages

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.

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
see arm/group descriptions

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Percent change in weight from baseline
Lasso di tempo: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
~8 weeks, ~16 weeks, and ~42 weeks post-randomization

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body Mass Index (BMI) change from baseline
Lasso di tempo: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization
BMI = kg/m2
~8 weeks, ~16 weeks, and ~42 weeks post-randomization

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in self-efficacy to lose weight
Lasso di tempo: ~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
Weight Efficacy Lifestyle Questionnaire (Clark, Abrams,& Niaura, 1991)
~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
Physical activity change from baseline
Lasso di tempo: ~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.
~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
Change from baseline in fruit and vegetable servings intake from baseline
Lasso di tempo: ~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.
~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
Change from baseline in percent energy from fat intake
Lasso di tempo: ~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.
~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
Change from baseline in scores of perceived exercise benefits and barriers to engaging in exercise and physical activity
Lasso di tempo: ~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)
~8 weeks, ~16 weeks, and ~42 weeks post-randomization compared to baseline
Comparison of satisfaction with the program and suggestions for improvement between intervention and control groups
Lasso di tempo: ~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.

~16 weeks, and ~42 weeks post-randomization compared to baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Lawrence Cheskin, MD, Johns Hopkins Bloomberg School of Public Health

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 settembre 2016

Completamento primario (Effettivo)

27 settembre 2018

Completamento dello studio (Effettivo)

27 settembre 2018

Date di iscrizione allo studio

Primo inviato

7 agosto 2020

Primo inviato che soddisfa i criteri di controllo qualità

7 agosto 2020

Primo Inserito (Effettivo)

10 agosto 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 agosto 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 agosto 2020

Ultimo verificato

1 agosto 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 00007115

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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