Interactive Mobile Messaging for Weight Control Among the Underserved (TRIMM)
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Aktív összehasonlító: Standard Care
Individual assessment Lifestyle counseling
|
Individual assessment, lifestyle counseling
|
|
Kísérleti: TRIMM Intervention
Individual assessment Lifestyle counseling Text messages
|
Individuals in the TRIMM arm receive daily, individualized text-messages promoting positive lifestyle changes to support weight loss/management.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Biometrics
Időkeret: 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
Időkeret: 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
Időkeret: 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.
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Process survey
Időkeret: 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
|
Együttműködők és nyomozók
Publikációk és hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- 0003436
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Standard Care
-
Luzerner KantonsspitalToborzás
-
Ensho Health Intelligent Systems Inc.Jelentkezés meghívóvalTranstiretin amiloid kardiomiopátia ("ATTR-CM")Kanada
-
National University of SingaporeAgency for Science, Technology and Research; AMILI Pte. Ltd.Toborzás
-
Curis, Inc.BefejezveElőrehaladott szilárd daganatok vagy limfómákEgyesült Államok, Spanyolország, Koreai Köztársaság, Egyesült Királyság
-
Concentric AnalgesicsBefejezveHallux Valgus deformitásEgyesült Államok
-
University of LeipzigCuris, Inc.MegszűntMielodiszpláziás szindrómák | AnémiaNémetország
-
Idego srlBefejezveÖnhatékonyság | MotivációOlaszország
-
Western Sydney Local Health DistrictNational Heart Foundation, Australia; University of SydneyMég nincs toborzásSzívritmuszavarok, szív | Cardiomyopathiák | Kamrai tachycardia | Kamrai aritmia
-
National and Kapodistrian University of AthensAghia Sophia Children's Hospital of Athens; Institute of Educational Policy; Ministry...BefejezveFeszültség | Egészségfejlesztés | SerdülőkorGörögország