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

Environment and Health Group

Status: Completed

Conditions: Gestational Diabetes Mellitus

Treatments: Behavioral: Hola Bebe

Study type: Interventional

Funder types: Industry

Identifiers

NCT05489172

R44MD009454 (U.S. NIH Grant/Contract)

R44MD009454B

Details and patient eligibility

About

The investigators will conduct a pre-post study to evaluate the effectiveness of the Hola Bebe intervention on improving self-efficacy for healthy eating and physical activity, and on weight loss among Hispanic women with recent GDM. The Hola Bebe app provides a unique opportunity to provide an effective, culturally tailored lifestyle modification program. The investigators will provide training to health educators at the two participating sites to ensure consistency and fidelity of implementation.

Full description

The study builds on the investigators' previous research in which the investigator developed a culturally-tailored Spanish and English app for Latinas with recent GDM based on Social Cognitive Theory and Behavioral Economics.

The app-based program included 12 audio/visual behavioral and educational modules on healthy eating and physical activity, motivational texts, weight tracking, personalized action plans, tiered badges, videos (easy at-home exercises, user-friendly, easy-to-follow recipes, and building a balanced plate), and an online community to communicate with other participants. All content was in plain-language Spanish and English, with Spanish and English audio voice-over. Graphics were dynamic and incorporated culturally sensitive.

Enrollment: 77 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female;
• Self-identify as Latina;
• Overweight or obese (BMI > or =25);
• Age 18 to 45;
• Having had a pregnancy complicated by GDM within the prior 5 years.

Exclusion criteria

• Currently has a diagnosis for diabetes (type 1, type 2 or secondary form);
• Has underlying disease or treatment that might interfere with participation in or completion of the protocol (e.g., cancer, moderate or severe cardiovascular disease, HIV positive, active tuberculosis, lung disease, significant gastrointestinal conditions, renal disease, major psychiatric disorders, and other at the discretion of the study clinician);
• Has diseases associated with glucose metabolism;
• Takes certain medications (e.g., glucocorticoids) which interfere with glucose metabolism.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

A Single arm study to evaluate the effectiveness of Hola Bebe application

Other group

Description:

Participants will receive the handout "It's never too early to prevent diabetes" and will meet with the health educator at their CHC and download the Hola Bebe app. The health educator will advise participants to watch one module and complete an action plan for each of the first 12 weeks of study and encourage participants to weigh themselves weekly. The app includes the following features:1) educational/ behavioral audio visual modules, with automatic prompting to complete an action plan at the end of each module; 2) a motivational message library so that participants can chose which motivational texts they wish to receive, how often and time of day; 3) a community forum where participants can interact with each other and ask questions to the health educator; 4) tracking of weights to allow participants to see a graphic of their weight over time by inputting weekly weights; and 5) awards program where participants can earn badges for completing modules.

Treatment:

Behavioral: Hola Bebe