Overweight Clinical Trial
Official title:
mDiet: A Text Message Intervention for Weight Loss
The purpose of the National Cancer Institute (NCI) funded randomized controlled study is to develop and evaluate a text message (SMS) based weight loss intervention to 309 overweight or moderately obese English and Spanish speaking adults ages 21 - 60. The investigators propose that participants randomized to the intervention arms will lose significantly more weight than those participants randomized to the control group.
The SMS based intervention will be developed through formative research including focus
groups, cognitive interviews, and a pilot test of a Spanish version of mDIET. The focus
groups will be conducted with both English and Spanish speaking men and women to 1) learn
more about the content areas to be addressed in the intervention including physical activity
and sedentary behaviors to expand on previous research; 2) learn more about assessing
equivalence and compatibility in intervention messages in English and Spanish; 3) identify
the most culturally and linguistically appropriate messages; 4) assess text message use; 5)
identify factors that influence food and physical activity decisions; and 6) identify health
messages that Latinos see as most understandable, credible, and persuasive, cognitive
interviews, and a pilot test of a Spanish version of mDIET. The cognitive interviews will be
conducted in Spanish and will help inform translation of study materials (text messages and
measures) from English to Spanish. An 8-week pilot test of the Latino (Spanish language)
mDIET will be conducted to ensure that the text messages and SMS system works as expected in
terms of usability and acceptability.
The randomized controlled trial will be a 12-month intervention with 309 study participants.
Participants will be randomized to one of three groups: SMS-only, SMS plus phone counseling,
and a control group (Details of the study arms are discussed in another section). The goals
of the intervention groups (SMS-only and SMS plus phone counseling) include: 5% weight loss,
500 k/cal per day deficit through reduced caloric intake and increased energy expenditure,
12,00 steps through the use of a pedometer, and a reduction in sedentary behaviors.
Participants will receive daily text messages, self-monitoring tools, and brief health
promotion printed or wed materials on physical activity, nutrition, or other weight loss
related topics. Participants will complete physiological and survey measures at baseline, 6
months, and 12 months to assess weight (BMI), physical activity and diet behaviors,
psychosocial behaviors, environmental factors, and exposure and satisfaction with the
program.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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