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CompletedNCT02385591SMS-StanfordUpdated Jan 10, 2020

Innovative Physical Activity Interventions for Overweight Latinos

An interventional study of Telephone Support and SMS Support in Sedentary Lifestyle, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-10.

Sponsored by Stanford University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2014, registered Mar 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
35 Years and older
Sex
All
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Study 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. 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.

02

Conditions studied

  • Sedentary Lifestyle

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Keywords

  • physical activity
  • Latinos
  • overweight
  • SMS
  • mHealth
03

In context

Overweight

3,671 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's enrollment of 350 is above the median of 74 across 3,176 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
350 participants (actual)

Study arms

  • 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

  • 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

  • Active comparator
    Attention-control

    Participants will receive telephone-based general nutrition advice.

    Behavioral: SMS Support

Interventions

  • BehavioralTelephone Support

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

    Also known as: Active Choices

  • BehavioralSMS Support

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

06

What researchers measure

Primary outcomes

  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)

    Time frame: baseline, 6 months, 12 months

Secondary outcomes

  1. Body weight stability from baseline to 12 months

    body weight measured by portable digital scale in kg

    Time frame: 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)

    Time frame: baseline, 6 months, 12 months

07

Study locations

1 site
  • Stanford Prevention Research Center
    Palo Alto, California 94304, United States
08

References and documents

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 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02385591
Lead sponsor
Stanford University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Abby C King (Professor, Stanford University) — Principal investigator
First posted
Mar 11, 2015
Start date
Sep 5, 2014
Primary completion
Sep 18, 2018
Completion
Aug 31, 2019
Last update
Jan 10, 2020

Study contacts

Abby C King, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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