Text4Diet: A Text Messaging Program for Weight Loss

NCT ID: NCT01571258

Last Updated: 2012-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Text Messaging (Intervention) Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Text Messaging

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.

Group Type EXPERIMENTAL

Text Messaging

Intervention Type BEHAVIORAL

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.

Interventions

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Text Messaging

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

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Santech, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Jennifer Shapiro, PhD

Scientific Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Shapiro, PhD

Role: STUDY_DIRECTOR

Santech, Inc

Locations

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Santech, Inc.

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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4R44CA138011

Identifier Type: NIH

Identifier Source: secondary_id

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4R44CA138011

Identifier Type: NIH

Identifier Source: org_study_id

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