Mobile Health App to Reduce Diabetes in Latina Women

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149054
• Other study ID #: R44 MD009454A
• Status: Completed
• Phase: Phase 1
• Start date: July 22, 2014
• Est. completion date: April 30, 2017

Study information

• Verified date: October 2019
• Source: Environment and Health Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Environment and Health Group	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Environment and Health Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Body weight	Body weight	eight weeks