Mobile Health App to Reduce Diabetes in Latina Women

Phase 1

Completed

• Conditions: Gestational Diabetes

• Registration Number: NCT04149054
• Lead Sponsor: Environment and Health Group, Inc.

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.

Study Timeline

• Study Start: 2014-07-22
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-30
• Last Update Submitted: 2019-10-30
• Study First Posted: 2019-11-04
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sallis Self Efficacy for Healthy Eating Scale	eight weeks	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	eight weeks	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

Name	Time	Method
Body weight	eight weeks	Body weight

Trial Locations

Locations (1)

Environment and Health Group; 🇺🇸 Cambridge, Massachusetts, United States