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Clinical Trials/NCT05489172
NCT05489172
Completed
N/A

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

Environment and Health Group, Inc.3 sites in 1 country77 target enrollmentFebruary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gestational Diabetes Mellitus
Sponsor
Environment and Health Group, Inc.
Enrollment
77
Locations
3
Primary Endpoint
Sallis Self Efficacy for Healthy Eating
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
July 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Sallis Self Efficacy for Healthy Eating

Time Frame: up to 6 months

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

Sallis Self Efficacy for Physical Activity

Time Frame: up to 6 month

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

Secondary Outcomes

  • Weight loss(up to 6 months)

Study Sites (3)

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