SBIR-STTR Award

Mobile Health APP to Reduce Diabetes in Latina Women with Prior Gestational Diabetes
Award last edited on: 2/2/2021

Sponsored Program
SBIR
Awarding Agency
NIH : NIMHD
Total Award Amount
$1,582,962
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Dharma E Cortes

Company Information

Environment And Health Group Inc (AKA: EHG)

1280 Mass Avenue Suite 203
Cambridge, MA 02138
   (617) 250-8596
   N/A
   www.ehginc.net
Location: Single
Congr. District: 05
County: Middlesex

Phase I

Contract Number: 1R43MD009454-01A1
Start Date: 7/22/2014    Completed: 4/30/2016
Phase I year
2014
Phase I Amount
$199,191
Hispanic women have the highest lifetime risk for type 2 diabetes (T2DM). A window of opportunity for preventing T2DM exists for women with pregnancies complicated by gestational diabetes mellitus (GDM). Women with prior GDM face increased risk of T2DM. Hispanic women are at increased risk of GDM, and those with GDM have higher relative risks for developing T2DM than non-Hispanic white women with GDM. The NIH-funded Diabetes Prevention Program (DPP) documented the effectiveness of lifestyle modification to prevent T2DM. Translating DPP research into community-based settings has been challenging. Recent development of mobile technologies offers promising solutions to taking knowledge obtained from experimental settings into community-based care. The proposed SBIR, building on the team's CDC-funded internet-based, GDM-modified DPP, would be the first to develop and test an interactive, culturally and individually-tailored, plain languae Spanish/English mobile health intervention (m-intervention) to reduce risk of T2DM for Hispanic women with recent GDM. The m-intervention leverages the widespread adoption of mobile phones in Hispanic women of reproductive age, and affords the opportunity to overcome physical barriers (accessible 24/7), knowledge barriers (education/skills development in plain Spanish/English), infrastructure barriers (not present using mobile phones), economic barriers (affordable), and cultural barriers (culturally acceptable). Using mobile phones to prevent T2DM in Hispanic women with prior GDM addresses the RFA's goal for...'existing technologies that have been redesigned based on the needs of a specific health disparity population.' The proposed system is technologically innovative using participant-generated text messages for themselves as well as others. The Spanish/English mobile app features: culturally/individually tailored educational/motivational texts for behavioral change; algorithm-derived, individually tailored texts that are a) participant generated; b) automated, based on prior participant-defined schedule, and c) just in-time, based on real time participant input about current activities; and weight tracking. Our long-term goal is the prevention of T2DM in this at-risk population. Formative evaluations test the cultural acceptability of the texts and the usability of the app. A pilot randomized trial explores effectiveness of the app in changes in self-efficacy for healthy eating (primary outcome), weight loss (secondary outcome), and HBA1C, perceived risk for T2DM, and modified perceived risk (exploratory). Phase I results will provide data to determine sample size for the development/submission of a Phase II RCT of the m-intervention to promote healthy lifestyle to achieve weight loss among Hispanic women with recent GDM. The m-intervention offers potential of a scalable and cost-effective approach to decreasing health disparities and to improving health outcomes in Hispanic women with recent GDM, a high-risk, yet underserved group. The proposed application has broad commercialization potential given changes in health care delivery.

Thesaurus Terms:
Address;Adopted;Adoption;Age;Algorithms;Base;Behavior Change;Behavior Therapy;Behavioral;Behavioral Health;Body Weight Decreased;Car Phone;Centers For Disease Control And Prevention (U.S.);Commercialization;Communities;Community Based Care;Comparison Group;Computers;Cost Effective;Data;Development;Diabetes Mellitus;Diabetes Prevention;Diabetes Prevention Program;Diet And Exercise;Diet Good;Eating;Economics;Educational Aspects;Effectiveness;English Language;Epidemic;Ethnicity Aspects;Evaluation/Testing;Evidence Base;Face;Funding;Future;Gender;Gestational Diabetes;Glosso-Sterandryl;Goals;Good Diet;Health;Health Care Delivery;Health Disparity;High Risk;Hispanic Americans;Hispanics;Improved;Infrastructure Development;Innovation;Innovative Technologies;Internet;Intervention;Knowledge;Language;Latina;Life Style;Lifetime Risk;Mhealth;Mobile Application;Modification;Non-Insulin-Dependent Diabetes Mellitus;Not Hispanic Or Latino;Obesity;Online Systems;Operating System;Outcome;Participant;Perception;Persons;Phase;Population;Populations At Risk;Pregnancy;Prevent;Prevention;Primary Outcome;Public Health Relevance;Race;Randomized;Randomized Clinical Trials;Randomized Trial;Recording Of Previous Events;Relative Risks;Reproductive;Research;Research Infrastructure;Risk;Risk Perception;Sample Size;Schedule;Secondary Outcome;Self Efficacy;Skills;Small Business Innovation Research Grant;Solutions;System;Technology;Telephone;Testing;Text;Theories;Time;Translating;Treatment As Usual;United States National Institutes Of Health;Usability;Weight;Woman;

Phase II

Contract Number: 5R43MD009454-02
Start Date: 7/22/2014    Completed: 4/30/2016
Phase II year
2015
(last award dollars: 2020)
Phase II Amount
$1,383,771

Hispanic women have the highest lifetime risk for type 2 diabetes (T2DM). A window of opportunity for preventing T2DM exists for women with pregnancies complicated by gestational diabetes mellitus (GDM). Women with prior GDM face increased risk of T2DM. Hispanic women are at increased risk of GDM, and those with GDM have higher relative risks for developing T2DM than non-Hispanic white women with GDM. The NIH-funded Diabetes Prevention Program (DPP) documented the effectiveness of lifestyle modification to prevent T2DM. Translating DPP research into community-based settings has been challenging. Recent development of mobile technologies offers promising solutions to taking knowledge obtained from experimental settings into community-based care. The proposed SBIR, building on the team's CDC-funded internet-based, GDM-modified DPP, would be the first to develop and test an interactive, culturally and individually-tailored, plain languae Spanish/English mobile health intervention (m-intervention) to reduce risk of T2DM for Hispanic women with recent GDM. The m-intervention leverages the widespread adoption of mobile phones in Hispanic women of reproductive age, and affords the opportunity to overcome physical barriers (accessible 24/7), knowledge barriers (education/skills development in plain Spanish/English), infrastructure barriers (not present using mobile phones), economic barriers (affordable), and cultural barriers (culturally acceptable). Using mobile phones to prevent T2DM in Hispanic women with prior GDM addresses the RFA's goal for..."existing technologies that have been redesigned based on the needs of a specific health disparity population." The proposed system is technologically innovative using participant-generated text messages for themselves as well as others. The Spanish/English mobile app features: culturally/individually tailored educational/motivational texts for behavioral change; algorithm-derived, individually tailored texts that are a) participant generated; b) automated, based on prior participant-defined schedule, and c) just in-time, based on real time participant input about current activities; and weight tracking. Our long-term goal is the prevention of T2DM in this at-risk population. Formative evaluations test the cultural acceptability of the texts and the usability of the app. A pilot randomized trial explores effectiveness of the app in changes in self-efficacy for healthy eating (primary outcome), weight loss (secondary outcome), and HBA1C, perceived risk for T2DM, and modified perceived risk (exploratory). Phase I results will provide data to determine sample size for the development/submission of a Phase II RCT of the m-intervention to promote healthy lifestyle to achieve weight loss among Hispanic women with recent GDM. The m-intervention offers potential of a scalable and cost-effective approach to decreasing health disparities and to improving health outcomes in Hispanic women with recent GDM, a high-risk, yet underserved group. The proposed application has broad commercialization potential given changes in health care delivery.

Public Health Relevance Statement:


Public Health Relevance:
The proposed study effort will develop, assess, and test an innovative mobile phone-based adaptation of the Diabetes Prevention Project to promote self-efficacy and behavioral change among Hispanic women with prior gestational diabetes mellitus (GDM), with the goal of preventing Type 2 diabetes mellitus (T2DM) in this population. The approach used in this culturally tailored, health behavioral theory-guided, and technology- based mobile intervention has the potential to improve health outcomes by helping Hispanic women with a history of GDM, an underserved group at a uniquely high risk of developing T2DM, adopt lifestyle changes (i.e., healthy diet, exercise) that may help protect them against future T2DM.

Project Terms:
Address; Adopted; Adoption; Algorithms; base; behavior change; Behavior Therapy; Behavioral; behavioral health; Body Weight decreased; Car Phone; Cellular Phone; Centers for Disease Control and Prevention (U.S.); commercialization; Communities; community based care; comparison group; Computers; cost effective; Data; Development; Diabetes Mellitus; Diabetes prevention; diabetes prevention program; diet and exercise; Eating; Economics; Educational aspects; Effectiveness; English Language; Epidemic; Ethnicity aspects; evaluation/testing; evidence base; Face; Funding; Future; Gender; Gestational Diabetes; Glosso-Sterandryl; Goals; good diet; Health; health care delivery; health disparity; high risk; Hispanic Americans; Hispanics; improved; infrastructure development; innovation; innovative technologies; Internet; Intervention; Knowledge; Language; Latina; Life Style; Lifetime Risk; mHealth; mobile application; Modification; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; Obesity; Online Systems; Operating System; Outcome; Participant; Perception; Persons; Phase; Population; Populations at Risk; Pregnancy; prevent; Prevention; primary outcome; Race; Randomized; Randomized Clinical Trials; randomized trial; Recording of previous events; Relative Risks; Research; Research Infrastructure; Risk; risk perception; Sample Size; Schedule; secondary outcome; Self Efficacy; skills; Small Business Innovation Research Grant; Solutions; System; Technology; Testing; Text; theories; Time; Translating; treatment as usual; United States National Institutes of Health; usability; Weight; Woman