Diabetes Mellitus, Type 2NCT06218147
Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes
A study testing Nutrition-behavior lifestyle program in people with Diabetes Mellitus, Type 2 and Diabetes Mel Gestational - in Pregnancy, run by Sansum Diabetes Research Institute at 1 site in United States.
Trial summary
Socioeconomically disadvantaged (SED) pregnant Latina women are disproportionately burdened by type 2 diabetes (T2D). Although lifestyle interventions can help to improve diabetes control, there are barriers to SED, Spanish-speaking pregnant people participating. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mel Gestational - in Pregnancy
- What is being tested?
- Nutrition-behavior lifestyle program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 27 Mar 2025
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diabetes in pregnancy
- ≥ 18 years old
- Self-reported Hispanic and/or Latino/a heritage
- BMI ≥ 26.0 kg/m2 and ≤ 42.0 kg/m2
Who cannot join
- Type 1 Diabetes
- Active substance abuse with alcohol or drugs by self-report
- Treatment with non-diabetes medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects that could affect outcome measures
- Non-singleton fetus
- Evidence of fetal malformation
- HbA1c ≥ 10%
- Unable to provide informed consent or unwilling to complete the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Socioeconomically disadvantaged (SED) pregnant Latina women are disproportionately burdened by type 2 diabetes (T2D). Although lifestyle interventions can help to improve diabetes control, there are barriers to SED, Spanish-speaking pregnant people participating. The purpose of this proposal is to develop and test a culturally tailored, dietary-lifestyle behavioral intervention that supports eating plant-based foods such as fruits, vegetables, nuts and grains instead of processed foods and meat, and is implemented through community health workers (CHWs) to prevent excessive weight gain during pregnancy and improve control of blood sugar levels in pregnant Latina women with T2D. This study takes advantage of our existing strong relationships with the local Latino community, CHWs, and Santa Barbara County Public Health, which includes eight multidisciplinary healthcare clinics with sliding fee programs, and Rooted Santa Barbara, a community plant-based lifestyle organization. Cultural sensitivity focuses on delivering health information based on norms, values, beliefs, environmental factors, and historical context that is unique to a racial/ethnic population. Therefore, for our program to be culturally sensitive, it will include delivery of the program by CHWs primarily in the Spanish language with English as needed and incorporation of culturally relevant eating and physical activity recommendations. The specific aims of the project are: 1) in year one, develop the dietary-lifestyle behavioral intervention that encourages a plant-forward diet for pregnant Latina women with T2D to prevent excessive weight gain during pregnancy and improve blood sugar control in collaboration with CHWs and participants by conducting focus groups to incorporate feedback on the program; 2) initiate in year one, and in year two, conduct a randomized controlled trial with 30 pregnant Latina women with T2D to evaluate the how well the nutrition-behavior lifestyle program works; and 3) evaluate the acceptance and delivery of the dietary-lifestyle behavioral intervention in CHWs and participants. If successful, this study will establish the how well a culturally sensitive program delivered by CHWs incorporating plant-forward diets for pregnant Latina women with T2D prevents excessive weight gain during pregnancy, and control of blood sugar levels.
- Being tested
- Nutrition-behavior lifestyle program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition-behavior lifestyle programBehavioural
Also called Plant forward dietary lifestyle intervention
The 15 participants randomized to the intervention group will complete the activities described in the arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| Standard care group | No intervention | Participants in this group will meet with their CHW for 8 sessions (almost weekly from weeks 14 to 27 gestation) and then 4 sessions (almost biweekly from weeks 28-35 gestation) to match the contact provided in dietary-lifestyle behavioral intervention group. Sessions will be held in person, with videoconferencing and phone call options available when in person is not possible. In these brief check-in sessions, the CHW will be focused on maintaining regular contact, connecting participants to community resources, checking in about any new or ongoing medical issues described by participant during each session visit, and providing overall general information about diabetes management when indicated. CGM will be blinded for both groups. |
| Nutrition-behavior lifestyle program group | Experimental | Participants in this group meet with their CHWs for 8 sessions (almost weekly from weeks 14 to 27 gestation) and then 4 sessions (almost biweekly from weeks 28-35 gestation). Sessions are held in person, with videoconferencing and phone call options available when in person is not possible. CGM wear is blinded in both groups. The topics for each session are:
1. Welcome and Understanding Diabetes in Pregnancy
2. Understanding Food Groups \& Setting Goals
3. Understanding Carbohydrate Types \& Portions
4. Reading Nutrition Labels \& Understanding Added Sugar
5. Exercise in Pregnancy \& Carbohydrate Counting
6. Grocery Shopping \& Using SNAP or WIC Benefits
7. Managing Stress - Communal Coping as a Family
8. Getting Ready for Baby \& My Family Plan
9. How to Receive Social Support
10. Making Choices at Restaurants \& Social Eating Settings
11. Learning Empowered Communication with Providers
12. Maintaining Changes \& Staying Motivated Receives: Behavioral: Nutrition-behavior lifestyle program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of glucose time in range assessed by using continuous glucose monitor
All participants will wear a Continuous Glucose Monitor for 30 days at three time points
Measured: 30 days at baseline and at 27 weeks gestation, and at 35 weeks gestation.
Secondary outcomes (3)
Amount of Gestational Weight Gain
weight gain in kilograms by measurements on a scale during study visits
Measured: assessed at baseline and post-intervention (approximately 27-35 weeks gestation)
Change in Blood Pressure
systolic and diastolic blood pressure
Measured: assessed at baseline and post intervention (approximately 27-35 weeks gestation)
Amount of satisfaction with the Intervention
self-reported satisfaction satisfaction with the intervention assessed by surveys created for the purposes of this study
Measured: evaluated immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Apr 2024
- Primary completion28 Feb 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachyl Pines, Sansum Diabetes Research Institute
- Investigators
- Rachyl Pines, PhD, Principal investigator, Sansum Diabetes Research Insititute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218147
- Sponsor's protocol ID
- SCON-00003510
- Status last verified
- Mar 2025
- First submitted
- 22 Dec 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes
- ClinicalTrials.gov ID
- NCT06218147
- Acronym / sponsor ID
- SCON-00003510
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 23 Jan 2024 (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.
Socioeconomically disadvantaged (SED) pregnant Latina women are disproportionately burdened by type 2 diabetes (T2D). Although lifestyle interventions can help to improve diabetes control, there are barriers to SED, Spanish-speaking pregnant people participating. The purpose of this proposal is to develop and test a culturally tailored, dietary-lifestyle behavioral intervention that supports eating plant-based foods such as fruits, vegetables, nuts and grains instead of processed foods and meat, and is implemented through community health workers (CHWs) to prevent excessive weight gain during pregnancy and improve control of blood sugar levels in pregnant Latina women with T2D. This study takes advantage of our existing strong relationships with the local Latino community, CHWs, and Santa Barbara County Public Health, which includes eight multidisciplinary healthcare clinics with sliding fee programs, and Rooted Santa Barbara, a community plant-based lifestyle organization. Cultural sensitivity focuses on delivering health information based on norms, values, beliefs, environmental factors, and historical context that is unique to a racial/ethnic population. Therefore, for our program to be culturally sensitive, it will include delivery of the program by CHWs primarily in the Spanish language with English as needed and incorporation of culturally relevant eating and physical activity recommendations. The specific aims of the project are: 1) in year one, develop the dietary-lifestyle behavioral intervention that encourages a plant-forward diet for pregnant Latina women with T2D to prevent excessive weight gain during pregnancy and improve blood sugar control in collaboration with CHWs and participants by conducting focus groups to incorporate feedback on the program; 2) initiate in year one, and in year two, conduct a randomized controlled trial with 30 pregnant Latina women with T2D to evaluate the how well the nutrition-behavior lifestyle program works; and 3) evaluate the acceptance and delivery of the dietary-lifestyle behavioral intervention in CHWs and participants. If successful, this study will establish the how well a culturally sensitive program delivered by CHWs incorporating plant-forward diets for pregnant Latina women with T2D prevents excessive weight gain during pregnancy, and control of blood sugar levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care group | No intervention | –Participants in this group will meet with their CHW for 8 sessions (almost weekly from weeks 14 to 27 gestation) and then 4 sessions (almost biweekly from weeks 28-35 gestation) to match the contact provided in dietary-lifestyle behavioral intervention group. Sessions will be held in person, with videoconferencing and phone call options available when in person is not possible. In these brief check-in sessions, the CHW will be focused on maintaining regular contact, connecting participants to community resources, checking in about any new or ongoing medical issues described by participant during each session visit, and providing overall general information about diabetes management when indicated. CGM will be blinded for both groups. |
| Nutrition-behavior lifestyle program group | Experimental | Behavioral: Nutrition-behavior lifestyle programParticipants in this group meet with their CHWs for 8 sessions (almost weekly from weeks 14 to 27 gestation) and then 4 sessions (almost biweekly from weeks 28-35 gestation). Sessions are held in person, with videoconferencing and phone call options available when in person is not possible. CGM wear is blinded in both groups. The topics for each session are: 1. Welcome and Understanding Diabetes in Pregnancy 2. Understanding Food Groups \& Setting Goals 3. Understanding Carbohydrate Types \& Portions 4. Reading Nutrition Labels \& Understanding Added Sugar 5. Exercise in Pregnancy \& Carbohydrate Counting 6. Grocery Shopping \& Using SNAP or WIC Benefits 7. Managing Stress - Communal Coping as a Family 8. Getting Ready for Baby \& My Family Plan 9. How to Receive Social Support 10. Making Choices at Restaurants \& Social Eating Settings 11. Learning Empowered Communication with Providers 12. Maintaining Changes \& Staying Motivated |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetes in pregnancy
- ≥ 18 years old
- Self-reported Hispanic and/or Latino/a heritage
- BMI ≥ 26.0 kg/m2 and ≤ 42.0 kg/m2
Key exclusion criteria (7 listed)
- Type 1 Diabetes
- Active substance abuse with alcohol or drugs by self-report
- Treatment with non-diabetes medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects that could affect outcome measures
- Non-singleton fetus
- Evidence of fetal malformation
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 |
|---|---|---|
| Nutrition-behavior lifestyle programAlso: Plant forward dietary lifestyle interventionThe 15 participants randomized to the intervention group will complete the activities described in the arm/group description. | Behavioural | Nutrition-behavior lifestyle program group |
Primary outcome
Percent of glucose time in range assessed by using continuous glucose monitor
Time frame: 30 days at baseline and at 27 weeks gestation, and at 35 weeks gestation.
All participants will wear a Continuous Glucose Monitor for 30 days at three time points
3 secondary outcomes
Amount of Gestational Weight Gain
Time frame: assessed at baseline and post-intervention (approximately 27-35 weeks gestation)
Change in Blood Pressure
Time frame: assessed at baseline and post intervention (approximately 27-35 weeks gestation)
Amount of satisfaction with the Intervention
Time frame: evaluated immediately post-intervention
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 3 Apr 2025.
- Individual participant dataSharing planned: No. IPD will not be shared
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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.
Rachyl Pines, PhD principal investigator
Sansum Diabetes Research Insititute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition-behavior lifestyle program in people with Diabetes Mellitus, Type 2 and Diabetes Mel Gestational - in Pregnancy, run by Sansum Diabetes Research Institute at 1 site 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 4 inclusion and 7 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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percent of glucose time in range assessed by using continuous glucose monitor (time frame: 30 days at baseline and at 27 weeks gestation, and at 35 weeks gestation.). 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 3 Apr 2025.