search
Back to results

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

Primary Purpose

Gestational Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hola Bebe
Sponsored by
Environment and Health Group, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Environment and Health GroupRecruiting
  • Brookside Community Health Center
  • Lynn Community Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.

Full Information

First Posted
August 3, 2022
Last Updated
August 3, 2022
Sponsor
Environment and Health Group, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05489172
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Environment and Health Group, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A Single arm study to evaluate the effectiveness of Hola Bebe application
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Hola Bebe
Intervention 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.
Primary Outcome Measure Information:
Title
Sallis Self Efficacy for Healthy Eating
Description
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
Time Frame
up to 6 months
Title
Sallis Self Efficacy for Physical Activity
Description
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
Time Frame
up to 6 month
Secondary Outcome Measure Information:
Title
Weight loss
Description
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.
Time Frame
up to 6 months
Other Pre-specified Outcome Measures:
Title
HbA1C level
Description
The exploratory outcome compares differences between T1 and T2 for HbA1C levels.
Time Frame
up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jim Maxwell
Phone
6175016943
Email
jim.h.maxwell@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Chapman
Phone
6178991021
Email
emma.chapman@ehgcambridge.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dharma Cortes
Organizational Affiliation
Environment and Health Group, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Environment and Health Group
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
james h maxwell, phd
Phone
617-250-8596
Email
jim.h.maxwell@gmail.com
First Name & Middle Initial & Last Name & Degree
emma chapman, m.a.
Phone
617-250-8596
Email
youyeshi@gmail.com
Facility Name
Brookside Community Health Center
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130-2240
Country
United States
Individual Site Status
Completed
Facility Name
Lynn Community Health Center
City
Lynn
State/Province
Massachusetts
ZIP/Postal Code
01901-2100
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey Pechinsky
Phone
781-581-3900
Email
GPechinsky@lchcnet.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs