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Text4Diet: A Text Messaging Program for Weight Loss

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jennifer Shapiro, PhD, Santech, Inc
ClinicalTrials.gov Identifier:
NCT01571258
First received: April 3, 2012
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Text Messaging (Intervention)
Control
Behavioral: Text Messaging

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Text4Diet: A Text Messaging Program for Weight Loss

Resource links provided by NLM:


Further study details as provided by Santech, Inc:

Primary Outcome Measures:
  • Weight [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    Change in average pedometer steps per day in the intervention group.

  • Adherence [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    Level of adherence in responding to SMS. We also will investigate the correlation between adherence and weight loss.

  • Treatment Satisfaction [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    We will assess satisfaction with the SMS intervention in the intervention group only.


Enrollment: 170
Study Start Date: September 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: 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.
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571258

Locations
United States, California
Santech, Inc.
San Diego, California, United States, 92121
Sponsors and Collaborators
Santech, Inc
Investigators
Study Director: Jennifer Shapiro, PhD Santech, Inc
  More Information

No publications provided

Responsible Party: Jennifer Shapiro, PhD, Scientific Director, Santech, Inc
ClinicalTrials.gov Identifier: NCT01571258     History of Changes
Other Study ID Numbers: 4R44CA138011, 4R44CA138011
Study First Received: April 3, 2012
Last Updated: April 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Santech, Inc:
SMS
Obesity
Text Messaging
Intervention
Mobile Phone

Additional relevant MeSH terms:
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014