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

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

Sponsors

Lead Sponsor: Environment and Health Group, Inc.

Source Environment and Health Group, Inc.
Brief Summary

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.

Detailed 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.

Overall Status Recruiting
Start Date 2020-02-01
Completion Date 2023-07-31
Primary Completion Date 2022-07-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Sallis Self Efficacy for Healthy Eating up to 6 months
Sallis Self Efficacy for Physical Activity up to 6 month
Secondary Outcome
Measure Time Frame
Weight loss up to 6 months
Enrollment 150
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Hola Bebe

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.

Arm Group Label: A Single arm study to evaluate the effectiveness of Hola Bebe application

Eligibility

Criteria:

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.

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

45 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Dharma Cortes Principal Investigator Environment and Health Group, Inc.
Overall Contact

Last Name: Jim Maxwell

Phone: 6175016943

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup:
Environment and Health Group | Cambridge, Massachusetts, 02138, United States Recruiting james h maxwell, phd 617-250-8596 [email protected]
Brookside Community Health Center | Jamaica Plain, Massachusetts, 02130-2240, United States Completed
Lynn Community Health Center | Lynn, Massachusetts, 01901-2100, United States Recruiting Geoffrey Pechinsky 781-581-3900 [email protected]
Location Countries

United States

Verification Date

2022-08-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

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

Type: Other

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.

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

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