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

NCT05489172 | Completed

• 2 other identifiers: R44MD009454BR44MD009454
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 3

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.

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Weight loss

  up to 6 months

Other Outcomes (1)

• HbA1C level

  up to 6 months

Study Arms (1)

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

OTHER

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.

Behavioral: Hola Bebe

Interventions

Hola Bebe BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Environment and Health Group, Inc.: lead

Study Sites (3)

Environment and Health Group

Cambridge, Massachusetts, 02138, United States

Location

Brookside Community Health Center

Jamaica Plain, Massachusetts, 02130-2240, United States

Location

Lynn Community Health Center

Lynn, Massachusetts, 01901-2100, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Officials

• Dharma Cortes

  Environment and Health Group, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: February 1, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-07

Locations

US (3)