Interactive Mobile Messaging for Weight Control Among the Underserved

NCT01814644 | Completed

• 1 other identifier: 0003436
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (10)

• Biometrics

  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

  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

  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.

  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

  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

  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

  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

  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

  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

  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

Secondary Outcomes (1)

• Process survey

  month 6

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Individual assessment Lifestyle counseling

Behavioral: Standard Care

TRIMM Intervention

EXPERIMENTAL

Individual assessment Lifestyle counseling Text messages

Behavioral: TRIMM Intervention

Interventions

TRIMM Intervention BEHAVIORAL

Individuals in the TRIMM arm receive daily, individualized text-messages promoting positive lifestyle changes to support weight loss/management.

TRIMM Intervention

Standard Care BEHAVIORAL

Individual assessment, lifestyle counseling

Standard Care

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Related Publications (1)

• 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.

  PMID: 25840035 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: March 20, 2013
• Study Start: July 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 3, 2018

Record last verified: 2018-03