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Text Messaging for Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
one way text
Personal feedback
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, weight loss, text message

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UT Physicians - Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personal feedback

One Way Text

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in weight from baseline
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)
Change in physical activity as measured by Paffenbarger physical activity questionnaire
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)
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.

Full Information

First Posted
November 7, 2012
Last Updated
November 9, 2015
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT01736111
Brief Title
Text Messaging for Weight Loss
Official Title
Text Messaging for Weight Loss in Primary Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, weight loss, text message

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personal feedback
Arm Type
Experimental
Arm Description
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
Arm Title
One Way Text
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
one way text
Intervention Type
Behavioral
Intervention Name(s)
Personal feedback
Primary Outcome Measure Information:
Title
Change in weight from baseline
Description
Weight in a lightweight hospital gown with no shoes (calibrated digital scale)
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in diet measured by Fruit and Vegetable Screener (NCI)
Time Frame
baseline and 6 months
Title
Change in physical activity as measured by Paffenbarger physical activity questionnaire
Time Frame
baseline and 6 months
Title
Change in social support as measured by Weight Management Support Inventory
Description
A validated questionnaire with 4 domains of social support for weight control (emotional, instrumental, informational, and appraisal)
Time Frame
baseline and 6 months
Title
Change in executive function as measured by Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Description
Measures the individual's self-rated executive functioning.
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin O. Hwang, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Physicians - Internal Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Text Messaging for Weight Loss

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