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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04149054
Other study ID # R44 MD009454A
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


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
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