Clinical trial NCT05489172: Mobile Health App to Reduce Diabetes in Latina Women With Prior Gestational Diabetes II
Official title: Mobile Health App to Reduce Diabetes in Latina Women With Prior Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Lead sponsor: Environment and Health Group, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Sallis Self Efficacy for Healthy Eating
timeFrame: up to 6 months
measure: Sallis Self Efficacy for Physical Activity
timeFrame: up to 6 month
Secondary outcomes:
measure: Weight loss
timeFrame: up to 6 months
Other outcomes:
measure: HbA1C level
timeFrame: up to 6 months
Locations:
city: Cambridge
country: United States
facility: Environment and Health Group
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Brookside Community Health Center
state: Massachusetts
city: Lynn
country: United States
facility: Lynn Community Health Center
state: Massachusetts
Study officials:
affiliation: Environment and Health Group, Inc.
name: Dharma Cortes
role: PRINCIPAL_INVESTIGATOR
References: