Clinical trial NCT01814644: Interactive Mobile Messaging for Weight Control Among the Underserved
Official title: Tailored Rapid Interactive Mobile Messaging (TRIMM) for Weight Control Among the Underserved
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2013-03-20
Enrollment: 124
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biometrics
timeFrame: Change from month 0 (baseline) to month 3, 6, and 12
measure: Impact of Weight on Quality of Life
timeFrame: Change from month 0 (baseline) to month 6
measure: Diet quality
timeFrame: Change from month 0 (baseline) to month 6
measure: Nutrition knowledge and beliefs.
timeFrame: Change from month 0 (baseline) to month 6
measure: Exercise Benefits/Barriers
timeFrame: Change from month 0 (baseline) to month 6
measure: Self-Efficacy for Exercise
timeFrame: Change from month 0 (baseline) to month 6
measure: Self-Efficacy for Weight Loss
timeFrame: Change from month 0 (baseline) to month 6
measure: Motivation/Readiness to Change
timeFrame: Change from month 0 (baseline) to month 6
measure: Depression
timeFrame: Change from month 0 (baseline) to month 6
measure: Barriers to Change
timeFrame: Change from month 0 (baseline) to month 6
Secondary outcomes:
measure: Process survey
timeFrame: month 6
Other outcomes:
Locations:
Study officials:
References:
citation: Lin M, Mahmooth Z, Dedhia N, Frutchey R, Mercado CE, Epstein DH, Preston KL, Gibbons MC, Bowie JV, Labrique AB, Cheskin LJ. Tailored, interactive text messages for enhancing weight loss among African American adults: the TRIMM randomized controlled trial. Am J Med. 2015 Aug;128(8):896-904. doi: 10.1016/j.amjmed.2015.03.013. Epub 2015 Mar 31.