search
Back to results

Text4Diet: A Text Messaging Program for Weight Loss (Text4Diet)

Primary Purpose

Text Messaging (Intervention), Control

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Messaging
Sponsored by
Santech, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Text Messaging (Intervention) focused on measuring SMS, Obesity, Text Messaging, Intervention, Mobile Phone

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age: 21 to 65 years
  • overweight or obese status: BMI between 25.0 and 39.9
  • regular access to the Internet
  • own and regularly use a cell phone and know how to use SMS
  • ability to read and speak English
  • ability to participate in moderate PA.

Exclusion Criteria:

  • current pregnancy or the intention of becoming pregnant during the 12 month trial
  • moving out of the country during the 12 month trial
  • current eating disorder

Sites / Locations

  • Santech, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Text Messaging

Arm Description

Participants in the intervention group will receive on average 4 texts per day consisting of weight related behavioral recommendations, knowledge based questions, and prompts to promote physical activity and weight monitoring. Texts are interactive and personally relevant based upon a baseline questionnaire.

Outcomes

Primary Outcome Measures

Weight
We will assess the difference in weight loss between the intervention and the control group at 6 months and 12 months.

Secondary Outcome Measures

Pedometer Steps/Day
Change in average pedometer steps per day in the intervention group.
Adherence
Level of adherence in responding to SMS. We also will investigate the correlation between adherence and weight loss.
Treatment Satisfaction
We will assess satisfaction with the SMS intervention in the intervention group only.

Full Information

First Posted
April 3, 2012
Last Updated
April 4, 2012
Sponsor
Santech, Inc
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01571258
Brief Title
Text4Diet: A Text Messaging Program for Weight Loss
Acronym
Text4Diet
Official Title
Text4Diet: A Text Messaging Program for Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Santech, Inc
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the present RCT is to evaluate a 12-month SMS intervention with expanded content, intervention strategies and interactive database logic, novel online enrollment, and automatic baseline scoring of measures to support a 12 month weight loss SMS intervention. The investigators hypothesized that the intervention group would have greater weight loss at 6 and 12 months than the control group and increased adherence to SMS would be associated with greater weight loss at 6 and 12 months.
Detailed Description
Background: Text messaging shows promise as an intervention mode for many health conditions due to its accessibility and timeliness . Few studies have evaluated the effectiveness of text message-based interventions for weight loss. This study is a randomized controlled trial comparing an intervention of daily text messaging (Text4Diet) focused on weight-related behaviors to a control group. Participant Involvement: One hundred seventy overweight or obese adults will have their height and weight measured and complete a battery of questionnaires at baseline, 6 and 12 months. Participants in the intervention group will receive on average 4 texts per day consisting of weight related behavioral recommendations, knowledge based questions, and prompts to promote physical activity and weight monitoring. Texts are interactive and personally relevant based upon a baseline questionnaire. The control group will receive only monthly newsletters but not text messages. Participants in both conditions will receive monetary compensation for participation, travel to the study site, and reimbursements for text messaging. Participants: Inclusion criteria consists of: a) age: 21 to 65 years, b) overweight or obese status: BMI between 25.0 and 39.9, c) regular access to the Internet, d) own and regularly use a cell phone and know how to use SMS, d) ability to read and speak English, and e) ability to participate in moderate PA. Exclusion criteria consists of a) current pregnancy or the intention of becoming pregnant during the 12 month trial, b) moving out of the country during the 12 month trial, and c) current eating disorder. Dates: Recruitment for the RCT began in September 2010. The RCT began in January 2011 and ended in December 2011. Data analysis will occur through June 2012. Location: San Diego, CA Risks to Participants: This study involves low risk. Participation may involve some discomforts, such as embarrassment from sharing information about home environment, weight, and technology, diet, and exercise habits. There is a risk of loss of confidentiality of research information. All risks will be minimized according to the study protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Text Messaging (Intervention), Control
Keywords
SMS, Obesity, Text Messaging, Intervention, Mobile Phone

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Text Messaging
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive on average 4 texts per day consisting of weight related behavioral recommendations, knowledge based questions, and prompts to promote physical activity and weight monitoring. Texts are interactive and personally relevant based upon a baseline questionnaire.
Intervention Type
Behavioral
Intervention Name(s)
Text Messaging
Intervention Description
Participants in the intervention group will receive on average 4 texts per day consisting of weight related behavioral recommendations, knowledge based questions, and prompts to promote physical activity and weight monitoring. Texts are interactive and personally relevant based upon a baseline questionnaire.
Primary Outcome Measure Information:
Title
Weight
Description
We will assess the difference in weight loss between the intervention and the control group at 6 months and 12 months.
Time Frame
6 months, 12 months
Secondary Outcome Measure Information:
Title
Pedometer Steps/Day
Description
Change in average pedometer steps per day in the intervention group.
Time Frame
6 months, 12 months
Title
Adherence
Description
Level of adherence in responding to SMS. We also will investigate the correlation between adherence and weight loss.
Time Frame
6 months, 12 months
Title
Treatment Satisfaction
Description
We will assess satisfaction with the SMS intervention in the intervention group only.
Time Frame
6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age: 21 to 65 years overweight or obese status: BMI between 25.0 and 39.9 regular access to the Internet own and regularly use a cell phone and know how to use SMS ability to read and speak English ability to participate in moderate PA. Exclusion Criteria: current pregnancy or the intention of becoming pregnant during the 12 month trial moving out of the country during the 12 month trial current eating disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Shapiro, PhD
Organizational Affiliation
Santech, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Santech, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Text4Diet: A Text Messaging Program for Weight Loss

We'll reach out to this number within 24 hrs