OverweightPhase 3NCT02648360
Text Messaging for Physical Activity & Healthy Eating
A Phase 3 study testing Text Messaging in people with Overweight, run by University of Miami.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Text Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Aug 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Pregnant women, children, or any other individuals that the physician deems not suitable for participation
About this study
Official title: Evaluation of a Text Messaging Program for Physical Activity and Healthy Eating for Underserved Hispanic Patients
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
- Conditions
- Overweight
- Being tested
- Text Messaging
- Keywords
- exercise, diet, patients, underserved, text messaging
- Medical subject headings
- Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessagingBehavioural
The content of the program will be delivered via 3 weekly text messages over a 4 month period of time.
| Study group | Role | What they receive |
|---|---|---|
| Text Messaging Intervention Arm | Experimental | 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. Receives: Behavioral: Text Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in physical activity levels from baseline at 4 months
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.
Measured: Change in dietary habits from baseline at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Stoutenberg, University of Miami
- Investigators
- Mark Stoutenberg, PhD, MSPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648360
- Sponsor's protocol ID
- 20151048
- Status last verified
- Dec 2016
- First submitted
- 5 Jan 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Text Messaging Program for Physical Activity and Healthy Eating for Underserved Hispanic Patients
- ClinicalTrials.gov ID
- NCT02648360
- Acronym / sponsor ID
- 20151048
- Conditions
- Overweight
- Keywords
- exercise, diet, patients, underserved, text messaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Text Messaging Intervention Arm | Experimental | Behavioral: Text MessagingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Pregnant women, children, or any other individuals that the physician deems not suitable for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text MessagingThe content of the program will be delivered via 3 weekly text messages over a 4 month period of time. | Behavioural | Text Messaging Intervention Arm |
Primary outcome
Mean change in activity levels as assessed by the Godin Leisure-Time Exercise Questionnaire
Time frame: Change in physical activity levels from baseline at 4 months
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.
Mean change in dietary habits as assessed by the Starting the Conversation Scale
Time frame: Change in dietary habits from baseline at 4 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Stoutenberg, PhD, MSPH principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Text Messaging in people with Overweight, run by University of Miami.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in activity levels as assessed by the Godin Leisure-Time Exercise Questionnaire (time frame: Change in physical activity levels from baseline at 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016; AzTrials last refreshed its copy on 3 Nov 2026.