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Text Messaging for Weight Loss

This study is currently recruiting participants.
Verified December 2012 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Kevin Hwang, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01736111
First received: November 7, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Behavioral: one way text
Behavioral: Personal feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Text Messaging for Weight Loss in Primary Care Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Change in weight from baseline [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Weight in a lightweight hospital gown with no shoes (calibrated digital scale)


Secondary Outcome Measures:
  • Change in diet measured by Fruit and Vegetable Screener (NCI) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in physical activity as measured by Paffenbarger physical activity questionnaire [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in social support as measured by Weight Management Support Inventory [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    A validated questionnaire with 4 domains of social support for weight control (emotional, instrumental, informational, and appraisal)

  • Change in executive function as measured by Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Measures the individual's self-rated executive functioning.


Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Personal feedback

This arm will receive all intervention components of Active Comparator group, plus the following:

  1. Text messages to prompt participant to reply with self-monitoring entries
  2. Human coach uses system to send personalized text messages with feedback on self-monitoring entries
  3. Participants (peers) support each other through text messaging.
 Behavioral: Personal feedback
Active Comparator: One Way Text

  1. 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.

  2. 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.
  3. Usual medical care from the PCP.
  4. 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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736111

Contacts
Contact: Kevin O. Hwang, MD (713) 500-6441
Contact: Landrus Burress 713-500-7904 Landrus.Burress@uth.tmc.edu

Locations
United States, Texas
UT Physicians - Internal Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Kevin O. Hwang, MD     713-500-6441        
Contact: Landrus Burress     713-500-7904     Landrus.Burress@uth.tmc.edu    
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Kevin O. Hwang, MD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Kevin Hwang, MD, Assistant Professor - Internal Medicine, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01736111     History of Changes
Other Study ID Numbers: HSC-MS-12-0571
Study First Received: November 7, 2012
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
obesity
weight loss
text message

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 19, 2013