mDiet: A Text Message Intervention for Weight Loss

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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mDiet: A Text Message Intervention for Weight Loss

Conditions
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Overweight, Weight Loss

Intervention / Treatment
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* Behavioral: mDiet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are 21 - 60 years Are overweight or moderately obese with a BMI between 27.0 - 39.9 Have a cell phone that is capable of sending and receiving text and picture messages Have a permanent residence in San Diego County and intend to stay over the entire study duration Speak and read English or Spanish Are willing to attend all (3) measurement assessments at the research office Provide assent and have a legal guardian that will participate and provide parental permission/consent Exclusion Criteria: Have any of the following conditions: pulmonary, cardiovascular, or musculoskeletal problems that would limit the ability to comply with moderate intensity physical activity (i.e. brisk walking) Are pregnant or intend to become pregnant during the study period Have a history of substance abuse Have a psychiatric disorder that would impair compliance with the study protocol Are using weight loss medications or supplements Are currently involved in another weight loss study or program

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS Only<br>The SMS only group will receive hints, tips, strategies, and questions related to weight loss behaviors, physical activity, nutrition, and motivation. The messages will be pushed to participants (i.e. no response needed) and pulled from participants (i.e. response is needed). The SMS only group will also receive a brief printed or web based outline on weight loss resources and information. | Behavioral: mDiet<br>* 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 pushed and pulled text messages, self-monitoring tools, and brief health promotion printed or wed materials on physical activity, nutrition, or other weight loss related topics.<br>|
| Experimental: SMS + Phone Counseling<br>This group will receive hints, tips, strategies, and questions related to weight loss behaviors, physical activity, nutrition, and motivation. The messages will be pushed to participants (i.e. no response needed) and pulled from participants (i.e. response is needed). The group will also receive monthly counseling calls from a Health Coach to discuss barriers and solutions and will receive a brief printed or web based outline on weight loss resources and information. | Behavioral: mDiet<br>* 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 pushed and pulled text messages, self-monitoring tools, and brief health promotion printed or wed materials on physical activity, nutrition, or other weight loss related topics.<br>|
| No Intervention: Control<br>The Control group will receive a binder with an attractive set of Standard Print Materials related to weight loss that is comparable to what one would receive from community resources such as libraries, magazines and national non-profit or governmental organizations such as 5-A Day, American Heart Association and the like. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | To evaluate differences from baseline in percent weight loss at 12 months. We hypothesize that, compared to the usual care Standard Print condition differences in weight loss will be significant in both the SMS only (SMS = short message service or text message) and SMS+Phone intervention groups. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Effects | To assess the intervention effects on weight loss by study group, diet, physical activity and sedentary behaviors, quality of life, and depression | 12 months | 
| Weight Loss Between Intervention Arms | To assess differences in weight loss between the 2 intervention arms (SMS only and SMS plus phone counseling) | 12 months | 
| Intervention Satisfaction and Exposure | To assess the level of satisfaction and use of the intervention components (SMS, phone counseling) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, overweight, weight loss, weight maintenance, SMS, technology, cell phone, physical activity, nutrition