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

30 maart 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

124

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Standard Care
Individual assessment Lifestyle counseling
Gedragsmatig: Standard Care
Individual assessment, lifestyle counseling
Experimenteel: TRIMM Intervention
Individual assessment Lifestyle counseling Text messages
Gedragsmatig: TRIMM Intervention
Individuals in the TRIMM arm receive daily, individualized text-messages promoting positive lifestyle changes to support weight loss/management.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Biometrics
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Process survey
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2011

Primaire voltooiing (Werkelijk)

1 maart 2013

Studie voltooiing (Werkelijk)

1 maart 2013

Studieregistratiedata

Eerst ingediend

31 juli 2012

Eerst ingediend dat voldeed aan de QC-criteria

19 maart 2013

Eerst geplaatst (Schatting)

20 maart 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 april 2018

Laatste update ingediend die voldeed aan QC-criteria

30 maart 2018

Laatst geverifieerd

1 maart 2018

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 0003436

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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