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Clinical Trials/NCT04149054
NCT04149054
Completed
Phase 1

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

Environment and Health Group, Inc.1 site in 1 country18 target enrollmentJuly 22, 2014

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
Environment and Health Group, Inc.
Enrollment
18
Locations
1
Primary Endpoint
Sallis Self Efficacy for Healthy Eating Scale
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 22, 2014
End Date
April 30, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patricia Weitzman

Principal Investigator

Environment and Health Group, Inc.

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.

Outcomes

Primary Outcomes

Sallis Self Efficacy for Healthy Eating Scale

Time Frame: 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

Time Frame: 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 Outcomes

  • Body weight(eight weeks)

Study Sites (1)

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