Mobile Health App to Reduce Diabetes in Latina Women

NCT ID: NCT04149054

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-22
• Study Completion Date: 2017-04-30

Brief Summary

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.

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.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Mobile health app called "Hola Bebe"

For the pilot, all participants received a mobile app that contained 6 interactive audio/written modules in Spanish and English on the following topics: healthy eating; physical activity; portion control; eating healthy while eating out; eating out in Chinese, Italian, Mexican restaurants; and eating out in fast food restaurants. As noted above, the mobile app was customizable to include personalized activity reminders/notifications, and tailored action plans, along with videos for easy at-home exercises and user-friendly, easy-to-follow recipes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Environment and Health Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Patricia Weitzman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Environment and Health Group

Cambridge, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33382039 (View on PubMed)

Other Identifiers

R44MD009454

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R44 MD009454A

Identifier Type: -

Identifier Source: org_study_id