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

Gestational Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05489172
• Other study ID #: R44MD009454B
• Secondary ID: R44MD009454
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: July 2023
• Source: Environment and Health Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Behavioral:
• Hola Bebe
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.

Locations

Country	Name	City	State
United States	Environment and Health Group	Cambridge	Massachusetts
United States	Brookside Community Health Center	Jamaica Plain	Massachusetts
United States	Lynn Community Health Center	Lynn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Environment and Health Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HbA1C level	The exploratory outcome compares differences between T1 and T2 for HbA1C levels.	up to 6 months
Primary	Sallis Self Efficacy for Healthy Eating	The investigators will use the eat habits confidence survey, which includes a list of things people might do while trying to change their eating habits. The investigators are mainly interested in salt and fat intake. There are 20 items to be scored in this survey. Exapmle questions are: 1. Stick to your low fat, low salt foods when you feel depressed, bored, or tense; 2. Stick to your low fat, low salt foods when there is high fat, high salt food readily available at a party.; The four factors for the Self-Efficacy and Eating Habits Survey should be scored as follows: Sticking to it: mean items I - 5 Reducing calories: mean items 6 - 10 Reducing salt: mean items 11 - 15 Reducing fat: mean items 16 - 20	up to 6 months
Primary	Sallis Self Efficacy for Physical Activity	The investigators will use the exercise confidence survey, which includes list of things people might do while trying to increase or continue regular exercise. The investigators are interested in exercises like running, swimming, brisk walking, bicycle riding, or aerobics classes.; There are 12 items to be scored in this survey (continued from the 1st eating habit survey).; Example questions are: 1. Get up early, even on weekends, to exercise; 2. Stick to your exercise program after a long, tiring day at work; 3. Exercise even though you are feeling depressed.; 24. Set aside time for a physical activity program; that is, walking, jogging. swimming, biking, or other continuous activities for at least 30; The two factors for the Self-Efficacy and Exercise Habits Survey should be scored as follows: Sticking to it: mean items 22, 23, 25, 26, 28 - 31 Making time for exercise: mean items 21, 24, 27, 32	up to 6 month
Secondary	Weight loss	The secondary outcome compares differences between T1 and T2 for percentage of baseline weight loss, calculated by subtracting weight at end of study dividing by baseline weight.	up to 6 months