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CompletedNCT02648360Updated Dec 28, 2016

Text Messaging for Physical Activity & Healthy Eating

A Phase 3 interventional study of Text Messaging in Overweight, sponsored by University of Miami. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-28.

Sponsored by University of Miami · Phase 3, Interventional, and Supportive care

Phase
Phase 3
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Hispanics share a disproportionate burden of several of the nation's leading chronic diseases caused by poor lifestyle habits such as sedentary behavior and poor quality nutrition intake. This project will design, implement and evaluate the delivery and effectiveness of an existing health promotion text messaging program focused on increasing physical activity and improving dietary behaviors among medically underserved Hispanic patients. Adult Hispanic patients referred by their healthcare provider at a local free community health clinic will be invited to participate in the 4-month long study. Patients who agree to participate will be sent health promotion text messages and will complete a brief pre-post assessment battery. Patients who do not send an initial enrollment text (to agree to participate) will receive a follow up telephone call from the research team to encourage participation. Evaluations will consist of: (1) physician referral rates; (2) patient enrollment rates; (3) demographic differences (gender, age) in participants/non-participants; and (4) pre-post changes in levels of physical activity and quality dietary intake will be conducted. The results of this study will provide a better understanding of the feasibility and effectiveness of implementing referral-based text messaging programs among medically underserved Hispanic patients at high risk for chronic diseases.

Read the detailed description

Referral Process When a patient at the participating free community health clinic sees their health care provider, they will be given a referral card with information on how to enroll in the text messaging program. The referral will also be recorded in the patient's electronic health record. Health care providers will be encouraged to recommend the program to all their patients who they feel will benefit from improving their activity levels or dietary habits. Patients who receive referral cards (i.e., clearance) for either text messaging program will have the choice of programs to enroll in. If a healthcare provider feels that a patient is not capable of participating in one of the text messaging interventions (i.e., due to a dietary restriction or physical limitation) they will be given only the referral card to which they are cleared to participate. Patients will be asked to text the number on the referral card if they are interested in participating in the text messaging program (passive recruitment process). Patients who text the number on the referral card will receive an automated reply indicating that they will be contacted within 1-2 days. A research team member will call the patient back to explain the text messaging program and initiate the enrollment process.

Patients who do not initially enroll by texting the number on the card will receive a follow up call by a clinic employee or volunteer approximately one to two weeks after the health care provider provides that patient with a referral (active recruitment process). The call will re-introduce the patient to the text messaging program and encourage their participation. If the patient agrees to enroll, they will be referred to the research team to initiate the enrollment process.

Data on the referral process (number of patients referred, referring physicians, etc.) may be shared with the research team at the discretion of the health clinic leadership. Shared information will be de-identified so that the research team will not be able to identify patients of the clinic.

Enrollment Process Patients that agree to participate in the program will be contacted by the research team. The patients will then be provided with an introduction to the study, the risks and benefits of participating, and asked to provide their verbal consent (see the "Verbal Consent" document in the Consent section of the protocol) agreeing to participate in the study. Following their verbal consent, eligible participants will be asked a number of questions about their demographic information, physical activity levels, and dietary habits (see the "Participant Questionnaire" document upload in the Supporting Document section).

At this point, the research team member will enroll the patient in the text messaging intervention. Participants will have the option of enrolling in the Physical Activity program (which focuses primarily on physical activity, but does include some dietary information) or the Nutrition program (which focuses primarily on nutrition, but does include some physical activity information) depending on the referral that they received as described above. Patients will be enrolled to the text messaging program on a rolling process throughout the study period.

If, during the enrollment process a patient declines to participate, they will be asked for their feedback on participating in the study (see the "Non-Participation Questions" document uploaded in the Supporting Document section) to seek information to improve the program and recruitment of participants in the future.

Text Messaging Program The text messaging programs to be used in this study were developed by Care Message, a non-profit organization based in San Francisco, CA. Care Message offers a cloud-based platform with options for several text messaging programs in English or Spanish on various topics such as health behavior change, chronic disease management, women's care, and preventive care. Programs last from 1 to 12 months, and consist of three weekly automated, culturally adapted, and interactive text messages designed to increase knowledge, self-efficacy, and improve health behaviors.

Study Assessments Evaluation of the effectiveness of the text messaging program will be conducted at baseline and at the completion of the 4-month intervention. An identical assessment protocol will be conducted at both time points to assess changes in eating habits and activity levels. Additionally, a participant satisfaction questionnaire will be conducted with study completers at the end of the intervention

02

Conditions studied

  • Overweight

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Keywords

  • exercise
  • diet
  • patients, underserved
  • text messaging
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 12 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Spanish speaking adults
  • Have a cell phone that they are able to use to send and receive text messages
  • Basic level of literacy (i.e., ability to read text messages)
  • Patients at the free community health clinic, who had an appointment with a physician during the study recruitment period
  • Clearance by physician to participate (i.e., provision of referral card by physician is equivalent to medical clearance)

Exclusion criteria

Exclusion Criteria:

  • Pregnant women, children, or any other individuals that the physician deems not suitable for participation
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Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Text Messaging Intervention Arm

    Participants will be enrolled in either a dietary or physical activity text messaging program. The dietary program will include nutritional education, reading nutrition labels, portion control, making lifestyle changes, finding social support, and identifying triggers. The physical activity program will provide information on the benefits of physical activity, exercise tips, and encouragement to live more active lifestyles. The programs have limited interactive capability; patients will be asked to respond to specific questions, but questions asked by the participants will be answered with an automated message asking them to contact their health care provider.

    Behavioral: Text Messaging

Interventions

  • BehavioralText Messaging

    The content of the program will be delivered via 3 weekly text messages over a 4 month period of time.

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What researchers measure

Primary outcomes

  1. Mean change in activity levels as assessed by the Godin Leisure-Time Exercise Questionnaire

    The Godin Leisure-Time Exercise Questionnaire has been found to be appropriate for assessing leisure time activity in a community setting with two week test-retest reliability coefficients of 0.48 for mild, 0.46 for moderate, and 0.94 for strenuous exercise. The questionnaire is brief, easily administered, reliable, and demonstrates concurrent validity with other tools.

    Time frame: Change in physical activity levels from baseline at 4 months

  2. Mean change in dietary habits as assessed by the Starting the Conversation Scale

    Starting The Conversation (STC) is a simplified screening instrument designed for non-dietitians in clinical practices for assessment and counseling. It identifies dietary patterns and was derived from a validated 54-item instrument.

    Time frame: Change in dietary habits from baseline at 4 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02648360
Lead sponsor
University of Miami
Responsible party
Mark Stoutenberg (Research Assistant Professor, University of Miami) — Principal investigator
First posted
Jan 7, 2016
Start date
Jan 2016
Primary completion
May 2016
Completion
Aug 2016
Last update
Dec 28, 2016

Study contacts

Mark Stoutenberg, PhD, MSPH
principal investigator · University of Miami

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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