Innovative Physical Activity Interventions for Overweight Latinos

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-05

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nutrition Intervention and Play Group Exercise for Low-income Latinas

NCT00454948

Obesity

COMPLETED NA

Text Based Mobile Technology and Weight Loss

NCT03203655

Obesity

COMPLETED NA

Project Impact: An Innovative Approach to Weight Loss Maintenance

NCT02363010

Obesity Weight Loss Overweight

COMPLETED NA

Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males

NCT02783521

Overweight Obesity

COMPLETED NA

Piloting a Patient Navigator Program for Weight Loss

NCT06972381

Obesity Overweight

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sedentary Lifestyle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Telephone Support

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

SMS Support

Intervention Type BEHAVIORAL

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

Attention-control

Participants will receive telephone-based general nutrition advice.

Group Type ACTIVE_COMPARATOR

SMS Support

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telephone Support

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

Intervention Type BEHAVIORAL

SMS Support

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Active Choices

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes