Gestational Diabetes MellitusNCT05489172
Mobile Health App to Reduce Diabetes in Latina Women With Prior Gestational Diabetes II
A study testing Hola Bebe in people with Gestational Diabetes Mellitus, run by Environment and Health Group, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Hola Bebe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2020to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Environment and Health Group
Cambridge, Massachusetts, 02138
Brookside Community Health Center
Jamaica Plain, Massachusetts, 02130-2240
Lynn Community Health Center
Lynn, Massachusetts, 01901-2100
About this study
Official title: Mobile Health App to Reduce Diabetes in Latina Women With Prior Gestational Diabetes
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.
Read the 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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Hola Bebe
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hola BebeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Hola Bebe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
- 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
Measured: up to 6 month
Secondary outcomes (1)
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Feb 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Environment and Health Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dharma Cortes, Principal investigator, Environment and Health Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489172
- Sponsor's protocol ID
- R44MD009454B
- Other IDs
- R44MD009454
- Status last verified
- Jul 2023
- First submitted
- 3 Aug 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health App to Reduce Diabetes in Latina Women With Prior Gestational Diabetes
- ClinicalTrials.gov ID
- NCT05489172
- Acronym / sponsor ID
- R44MD009454B
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Environment and Health Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A Single arm study to evaluate the effectiveness of Hola Bebe application | Other | Behavioral: Hola BebeParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hola BebeParticipants 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. | Behavioural | A Single arm study to evaluate the effectiveness of Hola Bebe application |
Primary outcome
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
1 secondary outcome
Weight loss
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dharma Cortes principal investigator
Environment and Health Group, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hola Bebe in people with Gestational Diabetes Mellitus, run by Environment and Health Group, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sallis Self Efficacy for Healthy Eating (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.