Mobile Health App to Reduce Diabetes in Latina Women

NCT04149054 | Completed Phase 1

• 2 other identifiers: R44 MD009454AR44MD009454
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Body weight

  eight weeks

Interventions

Mobile health app called "Hola Bebe" BEHAVIORAL

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.

Eligibility Criteria

• Age: 19 Years - 45 Years
• Gender Eligibility Details: The intervention exclusively targeted Latina women who had gestational diabetes in a prior pregnancy.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Environment and Health Group, Inc.: lead

Study Sites (1)

Environment and Health Group

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (1)

• 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.

  PMID: 33382039 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 4, 2019
• Study Start: July 22, 2014
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months post-study

Locations

US (1)