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Text Based Mobile Technology and Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CareMessage™
Control Condition
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Mobile text, Obesity, Hispanic, Women

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria (for both control and intervention groups)

  • Women between 18 21 and 65 years old,
  • Poor to normal English literacy,
  • Of Hispanic or Latin American origin,
  • Having access to a smart phone,
  • Obese (BMI 30-45).
  • Non-institutionalized population,
  • Currently not involved in any other weight loss program,
  • Sedentary population (exercising less than 90 minutes per week).

For the phone screening we will need the following data elements:

  • Female
  • BMI
  • Age
  • Ethnicity

Exclusion Criteria (for both groups):

  • Participants with a history of and/or current mental or physical disabilities.
  • Participants with BMI over 45

Sites / Locations

  • Washington University in St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Control Group

Arm Description

The intervention group will be enrolled in the CareMessage™ Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss.

The control group will receive the control condition. They will hear an initial talk about weight loss but will not be enrolled in any program or intervention.

Outcomes

Primary Outcome Measures

Body mass Index
is a measure of body fat based on height and weight that applies to adult men and women.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2017
Last Updated
February 13, 2019
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03203655
Brief Title
Text Based Mobile Technology and Weight Loss
Official Title
Efficacy of a Culturally Sensitive and Linguistically Appropriate Internet and Mobile-based Weight Loss Therapy in Obese Hispanic/Latino Adult Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
January 25, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hispanic populations in the US are dis-proportionally affected by high rates of obesity and diabetes; according to the Centers for Disease Control and Prevention, Latinos are the minority group with the second-highest obesity prevalence in adults. In comparison to the general female population (61.2%), Mexican American women (73%) have a greater overweight or obese percentage. In addition, more than 50% of Hispanic men and women are expected to develop type-2 diabetes over their lifetime, compared to 40% among whites. Hispanics are also 50% more likely to die from diabetes compared to whites. In many cases Hispanic populations do not have the knowledge, self-confidence and resources to participate in mainstream physical activity and nutrition interventions, which are usually geared towards the general population without considering cultural and linguistic differences. Information and communication technologies in the form of Internet and mobile phone access have grown enormously during the past decade; these technologies have the potential to affect food intake and physical activity as well as weight loss. Approximately 95% of countries have mobile telephone networks and about 70% of people worldwide use mobile phones. CareMessage is a Google-backed 501(c)3 nonprofit technology organization based in San Francisco that uses 'smart' text and voice messaging to enable clinical staff to provide automated yet personalized support to patients struggling with chronic conditions. The CareMessage™ Adult Obesity texting program adapts the Health Belief Model by strategically implementing behavioral concepts to help improve self-efficacy. The investigators will pilot test its effectiveness among a sample of Hispanic women who are at risk of obesity and diabetes by sending a culturally-sensitive and linguistically-appropriate text-based message three to 5 times a week, encouraging lifestyle modifications (diet and exercise education and behavior modification).
Detailed Description
The investigators will collect data on 40 obese (Body Mass Index 30-45) Hispanic women ages 21 to 65 years. The purpose of this research study is to test the efficacy of a mobile phone text message-based intervention on weight loss. After verifying eligibility and enrolling in the study, participants will come to Washington University School of Medicine, at Barnes-Jewish Hospital and fill out some questionnaires. The investigators will perform a brief exam that measures the lean and fat tissue using Dual Energy x-ray Absorptiometry (DXA) technology and will also do a modified 3-hour oral glucose tolerance test (MOGTT). Participants will wear an accelerometer (activity monitor) over a 7-day period at the beginning (before being randomized and enrolled in the intervention) and at the end of the study. Half of the participants will be randomized to the intervention group. The intervention group will be enrolled in the CareMessage™ Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss. The control group will receive an initial talk about weight loss but will not be enrolled in any program or intervention. After six months have passed, participants will return to Washington University School of Medicine, regardless of the group they were assigned to, for two final visits (a short one, to pick up another activity monitor seven days before the study ends, and a longer visit, to do some final testing and fill out some questionnaires).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Mobile text, Obesity, Hispanic, Women

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will be enrolled in the CareMessage™ Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss.
Arm Title
Control Group
Arm Type
Other
Arm Description
The control group will receive the control condition. They will hear an initial talk about weight loss but will not be enrolled in any program or intervention.
Intervention Type
Behavioral
Intervention Name(s)
CareMessage™
Intervention Description
Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss.
Intervention Type
Behavioral
Intervention Name(s)
Control Condition
Intervention Description
Control condition will receive an initial talk about weight loss but will not be enrolled in any program or intervention.
Primary Outcome Measure Information:
Title
Body mass Index
Description
is a measure of body fat based on height and weight that applies to adult men and women.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (for both control and intervention groups) Women between 18 21 and 65 years old, Poor to normal English literacy, Of Hispanic or Latin American origin, Having access to a smart phone, Obese (BMI 30-45). Non-institutionalized population, Currently not involved in any other weight loss program, Sedentary population (exercising less than 90 minutes per week). For the phone screening we will need the following data elements: Female BMI Age Ethnicity Exclusion Criteria (for both groups): Participants with a history of and/or current mental or physical disabilities. Participants with BMI over 45
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Parra
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Text Based Mobile Technology and Weight Loss

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