Text Messaging for Weight Loss

Study Overview
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Brief Summary
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Overweight and obese adults recruited from the primary care setting (n=150) will be enrolled in a 6-month randomized trial of the INTERVENTION versus CONTROL. Both groups will receive usual medical care, printed materials, and educational text messages. The INTERVENTION group will also receive personalized coaching and feedback, as well as peer support, via text message. The investigators hypothesize that compared to those in the Control group, patients in the Intervention group will lose more weight and demonstrate more favorable changes in fruit and vegetable intake, exercise, and social support for weight loss.

Official Title
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Text Messaging for Weight Loss in Primary Care Patients

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: one way text
* Behavioral: Personal feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Approved to participate by PCP (Patients with diabetes, hypertension, or dyslipidemia will be eligible if approved by their PCP) Age ≥ 21 years Body mass index (BMI) 25 to 45 kg/m2 and weight ≤ 400 pounds Goal of losing weight (not just maintain weight) Willing to change diet, physical activity in order to lose weight. Currently uses text messaging in English on mobile phone Willing to use send and receive text messages for this study without direct compensation for cost of messages (general compensation for study participation will be provided) Have a scale at home for self-monitoring weight Fluent in English (speak, read, write) Commit to return for follow-up weight at 6 months regardless of amount of weight lost Exclusion Criteria: Involuntary or voluntary weight loss of ≥ 5% body weight in previous 6 months Participating in research project involving weight loss, exercise, or dietary modification in the previous 6 months Any of the following medical conditions which could affect weight or for which weight loss is contraindicated End-stage liver disease End-stage kidney disease Cancer within previous 2 years (except non-melanoma skin cancer) Myocardial infarction, stroke, or transient ischemic attack within previous 6 months Unstable angina Severe arthritis or other medical conditions which would prevent brisk walking Schizophrenia Hospitalization for psychiatric problems during the prior 12 months. Current use or anticipated future use (during 6 month study) of medications that could cause weight loss: phentermine orlistat (prescription Xenical or OTC Alli) topiramate buprioprion exenatide (Byetta) liraglutide (Victoza) Prior bariatric surgery or plans for bariatric surgery in next 6 months Pregnant or breast feeding within the previous 6 months Planning to become pregnant in next 6 months Consumes > 14 alcoholic drinks per week Current use of illicit drugs Planning to move out of the area in the next 6 months Another member of household or a close contact is participating in the study

Ages Eligible for Study
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Minimum Age: 21 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personal feedback<br>This arm will receive all intervention components of Active Comparator group, plus the following: Text messages to prompt participant to reply with self-monitoring entries Human coach uses system to send personalized text messages with feedback on self-monitoring entries | Behavioral: Personal feedback<br> <br> |
| Active Comparator: One Way Text<br>Printed handouts from the Aim for a Healthy Weight booklet, which is published by National Heart, Lung, and Blood Institute and is frequently included in control conditions in primary care-based weight loss studies. Other handouts will discuss the use of prepackaged foods as well as setting goals for calorie intake, physical activity, and weight loss. One to three text messages per week, based on topics from Aim for a Healthy Weight and other sources. The text messages will be pre-scheduled, automated, non-tailored, and one-way (no reply will be requested). The total dose of contact will be low because each text message is limited to 160 characters. The condition is comparable in intensity to control conditions in other weight loss trials in the primary care setting. Usual medical care from the PCP. Education on symptoms of hypoglycemia, hypotension, and cardiovascular disease, with instructions to contact their PCP in the event of those symptoms. | Behavioral: one way text<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight from baseline | Weight in a lightweight hospital gown with no shoes (calibrated digital scale) | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diet measured by Fruit and Vegetable Screener (NCI) |  | baseline and 6 months | 
| Change in physical activity as measured by Paffenbarger physical activity questionnaire |  | baseline and 6 months | 
| Change in social support as measured by Weight Management Support Inventory | A validated questionnaire with 4 domains of social support for weight control (emotional, instrumental, informational, and appraisal) | baseline and 6 months | 
| Change in executive function as measured by Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) | Measures the individual's self-rated executive functioning. | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, weight loss, text message