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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01DK102016 (U.S. NIH Grant/Contract)

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