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Interactive Mobile Messaging for Weight Control Among the Underserved (TRIMM)

30 marzo 2018 aggiornato da: Johns Hopkins Bloomberg School of Public Health

Tailored Rapid Interactive Mobile Messaging (TRIMM) for Weight Control Among the Underserved

This project will test the efficacy of the "TRIMM" (Tailored Rapid Interactive Mobile Messaging) program, a user-friendly, semi-individualized text-messaging intervention to facilitate lifestyle change and weight loss among obese African-American adults with or at risk for diabetes, in a pilot, controlled clinical trial.

The text-messaging intervention will be in addition to, and compared with traditional diet, behavior, and physical activity education. Tips will be designed to increase knowledge, skills, and motivation.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Type-2 diabetes, and its most important risk factor, obesity, have become major strains on our nation's health care system. By 2050, one in three U.S. adults could have diabetes (Stobbe, 2010), and obesity currently contributes nearly 17% of U.S. medical costs (Cawley, 2010). Our nation's underserved urban minority populations disproportionately suffer from type-2 diabetes and obesity. African-Americans, for example, comprise 12% of the US population but 23% of the extremely obese (Livingston, 2004). To reduce diabetes, obesity must be addressed. Unfortunately, traditional obesity interventions are intrusive and costly.

This project will test the efficacy of the "TRIMM" (Tailored Rapid Interactive Mobile Messaging) program, a user-friendly, semi-individualized text-messaging intervention to facilitate lifestyle change and weight loss among obese African-American adults with or at risk for diabetes, in a pilot, controlled clinical trial.

The text-messaging intervention will be in addition to, and compared with traditional diet, behavior, and physical activity education. Tips will be designed to increase knowledge, skills, and motivation. Participants will have the option to receive spiritually-based messages, if desired.

166 overweight or obese men and women will be recruited from 10 Baltimore inner-city churches, and will be assigned to one of two, six-month lifestyle-change programs. Participants must be overweight, aged 21-65, and own a cell phone with text-messaging capability. To be eligible for the study, participants will need to first pass a health screening and meet other study criteria.

The McKesson Foundation is funding this study, which has a total of 5 visits, ranging from ½ hr. to 3 hrs. The active intervention will last 6 months, with a follow-up visit at month 12. The TRIMM Program will feature periodic, individualized text messages and feedback via the participant's mobile phone as well as periodic follow-up appointments. The traditional program will consist of traditional diet, behavior, and physical activity education.

Qualified participants will receive individualized weight-loss plans and monetary compensation for their time, effort, & parking.

The long-term goal is to demonstrate, using a real-life setting, the potential superiority in efficacy of a specific mHealth application (text-messaging) for an underserved population at high risk of type-2 diabetes, compared to traditional, often more costly, and currently underutilized lifestyle-change interventions.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

124

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 21 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Participants must be African-American,
  • aged 21-65,
  • have a phone with unlimited text/SMS capability,
  • a BMI > 27, and
  • be free from uncontrolled hypertension or other health or mental health condition that would make it inappropriate or unsafe for them to participate.

Exclusion Criteria:

  • Following initial assessments, participants will be excluded if they are currently abusing alcohol/other substances, or
  • have an Inventory of Depressive Symptomatology (IDS-SR) score > 38 ('severe to very severe' depression).

Potential participants with uncontrolled hypertension (> 160 systolic or >95 diastolic), HbA1c > 8, or symptomatic CAD will be referred for medical clearance.

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
Comparatore attivo: Standard Care
Individual assessment Lifestyle counseling
Comportamentale: Standard Care
Individual assessment, lifestyle counseling
Sperimentale: TRIMM Intervention
Individual assessment Lifestyle counseling Text messages
Comportamentale: TRIMM Intervention
Individuals in the TRIMM arm receive daily, individualized text-messages promoting positive lifestyle changes to support weight loss/management.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Biometrics
Lasso di tempo: Change from month 0 (baseline) to month 3, 6, and 12
Physical measures: weight, blood pressure, resting heart rate, height, and waist circumference
Change from month 0 (baseline) to month 3, 6, and 12
Impact of Weight on Quality of Life
Lasso di tempo: Change from month 0 (baseline) to month 6
The Lite Version (IWQOL-Lite)is a widely used, well-validated, and reliable 31-item survey of obesity related quality of life (Kolotkin, 2002).
Change from month 0 (baseline) to month 6
Diet quality
Lasso di tempo: Change from month 0 (baseline) to month 6
The 2005 Healthy Eating Index (HEI-2005) is a standardized tool that measures diet quality compared to MyPyramid.gov and the 2005 U.S. Dietary Guidelines. The 24-hour dietary recall is used to calculate the 12 components of the HEI-2005. HEI scores range from 0 to 100 (best) (USDA, 2000).
Change from month 0 (baseline) to month 6
Nutrition knowledge and beliefs.
Lasso di tempo: Change from month 0 (baseline) to month 6
The 2008 Health and Diet Survey (HDS) will be used to assess participant's knowledge and attitudes, important components of the Health Belief Model. Questions cover nutrition knowledge and attitudes, grocery shopping, food label use, etc.
Change from month 0 (baseline) to month 6
Exercise Benefits/Barriers
Lasso di tempo: Change from month 0 (baseline) to month 6
The Exercise Benefits/Barriers Scale (EBBS). This scale was developed to understand individuals' perceptions of the benefits of and barriers to participating in exercise.
Change from month 0 (baseline) to month 6
Self-Efficacy for Exercise
Lasso di tempo: Change from month 0 (baseline) to month 6
The Self-Efficacy for Exercise Scale (SEE) is a 13-item measure that focuses on self-efficacy and expectations related to the ability to continue to exercise in the face of barriers.
Change from month 0 (baseline) to month 6
Self-Efficacy for Weight Loss
Lasso di tempo: Change from month 0 (baseline) to month 6
Weight Efficacy Lifestyle Questionnaire (WEL). This will be used to assess self-efficacy for weight loss. The 20-item WEL consists of five situational factors: Negative Emotions, Availability, Social Pressure, Physical Discomfort, and Positive Activities.
Change from month 0 (baseline) to month 6
Motivation/Readiness to Change
Lasso di tempo: Change from month 0 (baseline) to month 6
University of Rhode Island Change Assessment Scale. (URICA; McConnaughy, Prochaska, & Velicer, 1983). This will be used to assess motivation and readiness to change; based on the Transtheoretical Model of health behavior change. Accurately assessing motivation or commitment to change is a crucial step in matching patients to appropriate interventions.
Change from month 0 (baseline) to month 6
Depression
Lasso di tempo: Change from month 0 (baseline) to month 6
The Inventory of Depressive Symptomatology: Self-Report. The DS-SR will be used to assess symptoms of depression (Rush, 1986, 1996). Its psychometric properties have been established in various populations (Rush 1996, 2000).
Change from month 0 (baseline) to month 6
Barriers to Change
Lasso di tempo: Change from month 0 (baseline) to month 6
These will be examined using a measure specifically developed for use in this study. Barriers assessed in the survey were identified via a focus group with the target population, existing literature on lifestyle change programs, and the investigators prior experience conducting health behavior change interventions.
Change from month 0 (baseline) to month 6

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Process survey
Lasso di tempo: month 6
Participants will be given a survey assessing intervention's ease of use, satisfaction and desire to continue use at 6 months to obtain process evaluation measures.
month 6

Collaboratori e investigatori

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

Sponsor

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.

Pubblicazioni generali

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

1 luglio 2011

Completamento primario (Effettivo)

1 marzo 2013

Completamento dello studio (Effettivo)

1 marzo 2013

Date di iscrizione allo studio

Primo inviato

31 luglio 2012

Primo inviato che soddisfa i criteri di controllo qualità

19 marzo 2013

Primo Inserito (Stima)

20 marzo 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 aprile 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 marzo 2018

Ultimo verificato

1 marzo 2018

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 0003436

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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