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

30. März 2018 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

124

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

21 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Standard Care
Individual assessment Lifestyle counseling
Verhalten: Standard Care
Individual assessment, lifestyle counseling
Experimental: TRIMM Intervention
Individual assessment Lifestyle counseling Text messages
Verhalten: TRIMM Intervention
Individuals in the TRIMM arm receive daily, individualized text-messages promoting positive lifestyle changes to support weight loss/management.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Biometrics
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Process survey
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2011

Primärer Abschluss (Tatsächlich)

1. März 2013

Studienabschluss (Tatsächlich)

1. März 2013

Studienanmeldedaten

Zuerst eingereicht

31. Juli 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. März 2013

Zuerst gepostet (Schätzen)

20. März 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. April 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. März 2018

Zuletzt verifiziert

1. März 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 0003436

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