Back to resultsMobile Health App to Reduce Diabetes in Latina Women
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mobile health app called "Hola Bebe"
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes
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.
Sites / Locations
- Environment and Health Group
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Body weight
Body weight
Full Information
NCT ID
NCT04149054
First Posted
October 29, 2019
Last Updated
October 30, 2019
Sponsor
Environment and Health Group, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04149054
Brief Title
Mobile Health App to Reduce Diabetes in Latina Women
Official Title
Mobile Health App to Reduce Diabetes in Latina Women With Prior Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 22, 2014 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
April 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Environment and Health Group, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Mobile health app called "Hola Bebe"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sallis Self Efficacy for Healthy Eating Scale
Description
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.
Time Frame
eight weeks
Title
Sallis Self Efficacy for Physical Activity Scale
Description
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.
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
Body weight
Description
Body weight
Time Frame
eight weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The intervention exclusively targeted Latina women who had gestational diabetes in a prior pregnancy.
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Environment and Health Group
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share study protocol, informed consent, and final report with other researchers.
IPD Sharing Time Frame
6 months post-study
Citations:
PubMed Identifier
33382039
Citation
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.
Results Reference
derived
Learn more about this trial
Mobile Health App to Reduce Diabetes in Latina Women
We'll reach out to this number within 24 hrs