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Sedentary LifestyleSMS-StanfordNCT02385591

Innovative Physical Activity Interventions for Overweight Latinos

A study testing Telephone Support and SMS Support in people with Sedentary Lifestyle, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 35 years and olderHealthy volunteers can take part
Conditions the study is for
Sedentary Lifestyle
What is being tested?
Telephone Support and SMS Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteUnited States
Study dates
5 Sep 2014to 31 Aug 2019
Phase
Interventional
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 35 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford Prevention Research Center

    Palo Alto, California, 94304

Other trials in United States

About this study

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.

Read the 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.

Being tested
Telephone Support, SMS Support
Keywords
physical activity, Latinos, overweight, SMS, mHealth
Medical subject headings
Sedentary Behavior, Motor Activity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telephone SupportBehavioural

    Also called Active Choices

    telephone-based physical activity advice and support delivered by a trained professional facilitator.

  • SMS SupportBehavioural

    Telephone-based physical activity advice and support delivered by SMS.

Study groups in NCT02385591
Study groupRoleWhat they receive
Telephone SupportExperimentalParticipants 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.
Receives: Behavioral: Telephone Support
SMS SupportExperimentalParticipants 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.
Receives: Behavioral: SMS Support
Attention-controlActive comparatorParticipants will receive telephone-based general nutrition advice.
Receives: Behavioral: SMS Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in weekly walking minutes from baseline to 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)

    Measured: baseline, 6 months, 12 months

Secondary outcomes (2)

  1. Body weight stability from baseline to 12 months

    body weight measured by portable digital scale in kg

    Measured: baseline, 6 months, 12 months

  2. Change in moderate-to-vigorous physical activity from baseline to 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)

    Measured: baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2015 (estimated)
  2. Study start5 Sep 2014
  3. Primary completion18 Sep 2018
  4. Study completion31 Aug 2019

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02385591
Sponsor's protocol ID
R01DK102016
Other IDs
R01DK102016
Acronym
SMS-Stanford
Status last verified
Jan 2020
First submitted
2 Mar 2015
Last updated
10 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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. doi: 10.1097/00005768-200107000-00010.

    PubMed 11445760

  • King AC, Campero MI, Rodriguez Espinosa P, Garcia D, Corral C, Sweet CC, Xiao L, Royer MF, Zamora A, Cortes AL, Done M, Banda JA. Human Telephone vs Text Message Counseling and Physical Activity Among Midlife and Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2528858. doi: 10.1001/jamanetworkopen.2025.28858.

    PubMed 40906479

  • King AC, Campero I, Sheats JL, Castro Sweet CM, Espinosa PR, Garcia D, Hauser M, Done M, Patel ML, Parikh NM, Corral C, Ahn DK. Testing the effectiveness of physical activity advice delivered via text messaging vs. human phone advisors in a Latino population: The On The Move randomized controlled trial design and methods. Contemp Clin Trials. 2020 Aug;95:106084. doi: 10.1016/j.cct.2020.106084. Epub 2020 Jul 11.

    PubMed 32659437

Questions about this trial

What is this clinical trial studying?

A study testing Telephone Support and SMS Support in people with Sedentary Lifestyle, run by Stanford University at 1 site in United States.

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 7 inclusion and 8 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 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

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?

Change in weekly walking minutes from baseline to 12 months (time frame: baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02385591, which also lists 3 linked publications.

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 10 Jan 2020.

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