- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01736111
Text Messaging for Weight Loss
Text Messaging for Weight Loss in Primary Care Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- UT Physicians - Internal Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Personal feedback
This arm will receive all intervention components of Active Comparator group, plus the following:
|
|
|
Active Comparator: One Way Text
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in weight from baseline
Time Frame: baseline and 6 months
|
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)
Time Frame: baseline and 6 months
|
baseline and 6 months
|
|
|
Change in physical activity as measured by Paffenbarger physical activity questionnaire
Time Frame: baseline and 6 months
|
baseline and 6 months
|
|
|
Change in social support as measured by Weight Management Support Inventory
Time Frame: baseline and 6 months
|
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)
Time Frame: baseline and 6 months
|
Measures the individual's self-rated executive functioning.
|
baseline and 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kevin O. Hwang, MD, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-12-0571
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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