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Trial record 72 of 661 for:    SMS

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

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ClinicalTrials.gov Identifier: NCT02385591
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Abby C King, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Behavioral: Telephone Support Behavioral: SMS Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Innovative Physical Activity Interventions for Overweight Latinos
Actual Study Start Date : September 5, 2014
Actual Primary Completion Date : September 18, 2018
Actual Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Change in moderate-to-vigorous intensity physical activity from baseline to 12 months [ Time Frame: baseline, 6 months, 12 months, 18 months ]
    Self-report and Objective measures: MVPA 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), and supported by Actigraph GT3X accelerometry


Secondary Outcome Measures :
  1. Body weight stability from baseline to 12 months, and through 18 months [ Time Frame: baseline, 6 months, 12 months, 18 months ]
    Objective measure- body weight measured by portable digital scale

  2. Reduction in waist circumference from baseline to 12 months, and through 18 months [ Time Frame: baseline, 6 months, 12 months, 18 months ]
    Objective measure - waist circumference measured by Gulick tape measure.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385591


Locations
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United States, California
Stanford Prevention Research Center
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Abby C King, PhD Stanford University

Publications of Results:
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Responsible Party: Abby C King, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02385591     History of Changes
Other Study ID Numbers: R01DK102016 ( U.S. NIH Grant/Contract )
R01DK102016 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Keywords provided by Abby C King, Stanford University:
physical activity
Latinos
overweight
SMS
mHealth
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms