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Completed

NCT Number: NCT04149054

Mobile Health App to Reduce Diabetes in Latina Women

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Environment and Health Group

Cambridge, Massachusetts, 02138, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile health app called "Hola Bebe"

Behavioral

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 outcomes

  1. 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.

  2. 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

  1. Body weight

    Time frame: eight weeks

    Body weight

Sponsors and collaborators

Lead sponsor

Environment and Health Group, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2019
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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