NCT02648360

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 28, 2016

Status Verified

December 1, 2016

Enrollment Period

4 months

First QC Date

January 5, 2016

Last Update Submit

December 27, 2016

Conditions

Keywords

exercisedietpatients, underservedtext messaging

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Change in dietary habits from baseline at 4 months

Study Arms (1)

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.

Behavioral: Text Messaging

Interventions

Text MessagingBEHAVIORAL

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

Text Messaging Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Mark Stoutenberg, PhD, MSPH

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 7, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

December 28, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share