Mobile Health App to Reduce Diabetes in Latina Women

Mobile Health App to Reduce Diabetes in Latina Women With Prior Gestational Diabetes

The proposed project sought to develop a culturally- and individually-tailored, plain-language Spanish/English mobile phone intervention for Latinas with prior gestational diabetes (GDM). The intervention is based on earlier in-person to online modification of the CDC-funded Diabetes Prevention Program (DPP), for women with prior GDM led by co-investigator Dr. Ellen Seely of Brigham and Women's Hospital.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Behavioral: Mobile health app called "Hola Bebe"

Detailed Description

The specific aims of the study were as follows:

Primary Aim 1: Develop a culturally-tailored mobile phone intervention for Latinas with prior GDM based on Brigham & Women's Hospital online DPP.

Primary Aim 2: Conduct a pilot trial of the intervention.

Primary Aim 3:Evaluate implementation feasibility.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Environment and Health Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Latina women
• ages 19-45
• with prior gestational diabetes by Carpenter and Coustan criteria
• within the past 5 year validated by medical record review
• own an Android or iOS smartphone.

Exclusion Criteria:

• Diagnosis of pre-pregnancy diabetes(type 1,2, or secondary diabetes)
• underlying disease that might interfere with participation in study (e.g.,significant gastrointestinal conditions)
• taking certain medications (e.g., glucocorticoids)
• pregnancy/undergoing infertility treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sallis Self Efficacy for Healthy Eating Scale	20 item survey that asks respondents to rate, on a 5-point scale, their confident motivating themselves to eat healthy on a regular basis for at least six months.	eight weeks
Sallis Self Efficacy for Physical Activity Scale	12 item survey that asks respondents to rate, on a 5-point scale, their confidence at motivating themselves to exercise on a regular basis for at least six months.	eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight	eight weeks

Collaborators and Investigators

• Sponsor: Environment and Health Group, Inc.

Publications and helpful links

General Publications

• Seely EW, Weitzman PF, Cortes D, Romero Vicente S, Levkoff SE. Development and Feasibility of an App to Decrease Risk Factors for Type 2 Diabetes in Hispanic Women With Recent Gestational Diabetes (Hola Bebe, Adios Diabetes): Pilot Pre-Post Study. JMIR Form Res. 2020 Dec 31;4(12):e19677. doi: 10.2196/19677.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2014
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: R44 MD009454A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share study protocol, informed consent, and final report with other researchers.
• IPD Sharing Time Frame: 6 months post-study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No