Innovative Physical Activity Interventions for Overweight Latinos (SMS-Stanford)
Primary Purpose
Sedentary Lifestyle
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone Support
SMS Support
Sponsored by

About this trial
This is an interventional prevention trial for Sedentary Lifestyle focused on measuring physical activity, Latinos, overweight, SMS, mHealth
Eligibility 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
Sites / Locations
- Stanford Prevention Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Telephone Support
SMS Support
Attention-control
Arm Description
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.
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.
Participants will receive telephone-based general nutrition advice.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Body weight stability from baseline to 12 months
body weight measured by portable digital scale in kg
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)
Full Information
NCT ID
NCT02385591
First Posted
March 2, 2015
Last Updated
January 7, 2020
Sponsor
Stanford University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02385591
Brief Title
Innovative Physical Activity Interventions for Overweight Latinos
Acronym
SMS-Stanford
Official Title
Innovative Physical Activity Interventions for Overweight Latinos
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 5, 2014 (Actual)
Primary Completion Date
September 18, 2018 (Actual)
Study Completion Date
August 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Lifestyle
Keywords
physical activity, Latinos, overweight, SMS, mHealth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone Support
Arm Type
Experimental
Arm Description
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.
Arm Title
SMS Support
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention-control
Arm Type
Active Comparator
Arm Description
Participants will receive telephone-based general nutrition advice.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Support
Other Intervention Name(s)
Active Choices
Intervention Description
telephone-based physical activity advice and support delivered by a trained professional facilitator.
Intervention Type
Behavioral
Intervention Name(s)
SMS Support
Intervention Description
Telephone-based physical activity advice and support delivered by SMS.
Primary Outcome Measure Information:
Title
Change in weekly walking minutes from baseline to 12 months
Description
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 Outcome Measure Information:
Title
Body weight stability from baseline to 12 months
Description
body weight measured by portable digital scale in kg
Time Frame
baseline, 6 months, 12 months
Title
Change in moderate-to-vigorous physical activity from baseline to 12 months
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abby C King, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Prevention Research Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11445760
Citation
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.
Results Reference
result
PubMed Identifier
32659437
Citation
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.
Results Reference
derived
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Innovative Physical Activity Interventions for Overweight Latinos
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