NCT03203655

Brief Summary

Hispanic populations in the US are dis-proportionally affected by high rates of obesity and diabetes; according to the Centers for Disease Control and Prevention, Latinos are the minority group with the second-highest obesity prevalence in adults. In comparison to the general female population (61.2%), Mexican American women (73%) have a greater overweight or obese percentage. In addition, more than 50% of Hispanic men and women are expected to develop type-2 diabetes over their lifetime, compared to 40% among whites. Hispanics are also 50% more likely to die from diabetes compared to whites. In many cases Hispanic populations do not have the knowledge, self-confidence and resources to participate in mainstream physical activity and nutrition interventions, which are usually geared towards the general population without considering cultural and linguistic differences. Information and communication technologies in the form of Internet and mobile phone access have grown enormously during the past decade; these technologies have the potential to affect food intake and physical activity as well as weight loss. Approximately 95% of countries have mobile telephone networks and about 70% of people worldwide use mobile phones. CareMessage is a Google-backed 501(c)3 nonprofit technology organization based in San Francisco that uses 'smart' text and voice messaging to enable clinical staff to provide automated yet personalized support to patients struggling with chronic conditions. The CareMessage™ Adult Obesity texting program adapts the Health Belief Model by strategically implementing behavioral concepts to help improve self-efficacy. The investigators will pilot test its effectiveness among a sample of Hispanic women who are at risk of obesity and diabetes by sending a culturally-sensitive and linguistically-appropriate text-based message three to 5 times a week, encouraging lifestyle modifications (diet and exercise education and behavior modification).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

November 27, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2019

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

June 28, 2017

Last Update Submit

February 13, 2019

Conditions

Keywords

Mobile textObesityHispanicWomen

Outcome Measures

Primary Outcomes (1)

  • Body mass Index

    is a measure of body fat based on height and weight that applies to adult men and women.

    6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will be enrolled in the CareMessage™ Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss.

Behavioral: CareMessage™

Control Group

OTHER

The control group will receive the control condition. They will hear an initial talk about weight loss but will not be enrolled in any program or intervention.

Behavioral: Control Condition

Interventions

CareMessage™BEHAVIORAL

Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss.

Intervention Group

Control condition will receive an initial talk about weight loss but will not be enrolled in any program or intervention.

Control Group

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women between 18 21 and 65 years old,
  • Poor to normal English literacy,
  • Of Hispanic or Latin American origin,
  • Having access to a smart phone,
  • Obese (BMI 30-45).
  • Non-institutionalized population,
  • Currently not involved in any other weight loss program,
  • Sedentary population (exercising less than 90 minutes per week).
  • For the phone screening we will need the following data elements:
  • Female
  • BMI
  • Age
  • Ethnicity

You may not qualify if:

  • Participants with a history of and/or current mental or physical disabilities.
  • Participants with BMI over 45

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63105, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Diana Parra

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2017

First Posted

June 29, 2017

Study Start

November 27, 2017

Primary Completion

January 25, 2019

Study Completion

January 31, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations