Innovative Physical Activity Interventions for Overweight Latinos (SMS-Stanford)

January 7, 2020 updated by: Abby C King, Stanford University
This research aims to investigate the effectiveness of an automated Simple Message Service (SMS, also known as text messaging) advisor system relative to a proven human advisor program to promote regular, sustained physical activity among inactive, overweight Latinos. The SMS Advisor program represents a potentially lower-cost and high yield alternative to person-delivered health promotion programs that could be more rapidly disseminated with greater and faster uptake.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Latinos are the fastest growing ethnic group in the US and are disproportionately impacted by chronic conditions (e.g., overweight/obesity, diabetes) that can be mitigated by physical activity. While evidence-based programs are available to improve physical activity, dissemination is constrained by reliance on costly, limited resources. Short message service (SMS or text messaging) has strong potential as an intervention medium for Latinos, as they are dominant users of mobile phones and text messaging, including those with limited literacy and computer skills. The investigators propose to develop a personalized, culturally-congruent and interactive SMS program to promote the adoption and maintenance of physical activity for overweight, underactive Latino adults and test it for comparable efficacy to an evidence-based telephone-based advising program that has been used successfully with Latinos. Grounded in Social Cognitive and Self-Determination Theories, both programs will include a core set of self-regulatory skill building, social support, and autonomous motivation enhancement, and will be tailored for cultural, linguistic and literacy appropriateness. Randomized at the individual level, 376 sedentary, overweight Latinos ages 45 years and older will be assigned to one of three arms: the SMS-delivered physical activity program, the Human-delivered physical activity program, or an attention-control arm of SMS-delivered basic healthful nutrition advice. They will receive their assigned program for 12 months, and then will be followed for a 6-month maintenance phase, with a final assessment at 18 months. Analyses will determine if the two physical activity programs result in equivalent efficacy in adoption and maintenance of clinically meaningful physical activity increases, and superiority over the attention-control arm at 12 and 18 months. The two physical activity interventions will also be compared for equivalency in prevention of weight gain and reduction in abdominal adiposity. The investigators will explore the relative costs of the programs to determine which program increases physical activity for a lower cost. While health promotion programs delivered by professional staff may be more expensive than those delivered electronically, it is unclear if the automated version can produce more cost-efficient outcomes (i.e., comparable improvements in outcomes for significantly reduced cost). This study will determine if SMS is equivalent in efficacy to the traditional human-delivery channel in increasing physical activity and preventing weight gain, and if it results in a more cost-efficient program. If achieved, this research can significantly reduce health disparities associated with physical activity for Latinos by providing an efficacious, tailored and culturally appropriate program poised for widespread dissemination and rapid uptake.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Prevention Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Self-identified Latino ethnicity;
  • Body Mass Index between 25 and 40;
  • Aged greater than or equal to 35 years
  • Physically inactive (i.e., not engaged in moderate- or greater intensity PA at least 60 minutes/week over the past 6 months);
  • Stable on all medications over the past 3 months;
  • Regular access to a mobile phone;
  • Willing to accept random assignment, and willing to complete all assessments.

Exclusion Criteria:

  • Aged less than 35 years
  • Body Mass Index greater than 40
  • Physically active (i.e., engaged in moderate- or greater intensity PA for more than 60 minutes/week over the past 6 months);
  • Not stable on all medications over the past 3 months;
  • No regular access to a mobile phone;
  • Not willing to accept random assignment and/or willing to complete all assessments.
  • Medical contraindications to regular unsupervised PA, including uncontrolled metabolic disorders;
  • Unable to understand English or Spanish sufficiently to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telephone Support
Participants will receive bi-weekly 20 minute telephone calls from a trained professional facilitator offering physical activity advice with the goal of increasing moderate-to-vigorous intensity physical activity.
Behavioral: Telephone Support
telephone-based physical activity advice and support delivered by a trained professional facilitator.
Other Names:
  • Active Choices
Experimental: SMS Support
Participants will receive weekly text messages (3-5 text messages per week) offering physical activity advice with the aim of increasing moderate-to-vigorous intensity physical activity.
Behavioral: SMS Support
Telephone-based physical activity advice and support delivered by SMS.
Active Comparator: Attention-control
Participants will receive telephone-based general nutrition advice.
Behavioral: SMS Support
Telephone-based physical activity advice and support delivered by SMS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weekly walking minutes from baseline to 12 months
Time Frame: baseline, 6 months, 12 months
Total weekly walking minutes measured by CHAMPS questionnaire (Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001 Jul;33(7):1126-41)
baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight stability from baseline to 12 months
Time Frame: baseline, 6 months, 12 months
body weight measured by portable digital scale in kg
baseline, 6 months, 12 months
Change in moderate-to-vigorous physical activity from baseline to 12 months
Time Frame: baseline, 6 months, 12 months
Moderate-to-vigorous physical activity measured by CHAMPS questionnaire (Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001 Jul;33(7):1126-41)
baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Abby C King, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2014

Primary Completion (Actual)

September 18, 2018

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Actual)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DK102016 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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