← Back to Search

Behavioural Intervention

Nutrition-behavior lifestyle program group for Type 2 Diabetes

N/A

Recruiting

Led By Rachyl Pines, PhD

Research Sponsored by Sansum Diabetes Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diabetes in pregnancy

≥ 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated immediately post-intervention

Awards & highlights

Study Summary

This trial aims to develop and test a program for pregnant Latina women with type 2 diabetes that encourages them to eat more plant-based foods and less processed foods and meat. The program will be implemented by

Who is the study for?

This trial is for pregnant Latina women with diabetes, aged 18 or older, who self-identify as Hispanic/Latino and have a BMI between 26.0 and 42.0 kg/m2. It's not for those with Type 1 Diabetes, active substance abuse issues, on certain medications like corticosteroids or antipsychotics, carrying multiple fetuses, if there are fetal malformations present, HbA1c levels ≥10%, or unable to consent.Check my eligibility

What is being tested?

The study tests a culturally tailored nutrition-behavior lifestyle program aimed at preventing excessive weight gain and improving blood sugar control during pregnancy. Delivered by community health workers (CHWs), it promotes eating plant-based foods over processed ones through a randomized controlled trial involving the local Latino community.See study design

What are the potential side effects?

Since this intervention focuses on dietary-lifestyle changes rather than medication, side effects may include typical reactions to diet change such as gastrointestinal discomfort but will vary based on individual health conditions and adherence to the program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had diabetes during my pregnancy.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days at baseline and at 27 weeks gestation, and at 35 weeks gestation.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days at baseline and at 27 weeks gestation, and at 35 weeks gestation.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days at baseline and at 27 weeks gestation, and at 35 weeks gestation. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent of glucose time in range assessed by using continuous glucose monitor

Secondary outcome measures

Amount of Gestational Weight Gain

Amount of satisfaction with the Intervention

Change in Blood Pressure

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Nutrition-behavior lifestyle program groupExperimental Treatment1 Intervention

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: Welcome and Understanding Diabetes in Pregnancy Understanding Food Groups & Setting Goals Understanding Carbohydrate Types & Portions Reading Nutrition Labels & Understanding Added Sugar Exercise in Pregnancy & Carbohydrate Counting Grocery Shopping & Using SNAP or WIC Benefits Managing Stress - Communal Coping as a Family Getting Ready for Baby & My Family Plan How to Receive Social Support Making Choices at Restaurants & Social Eating Settings Learning Empowered Communication with Providers Maintaining Changes & Staying Motivated

Group II: Standard care groupActive Control1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sansum Diabetes Research InstituteLead Sponsor

38 Previous Clinical Trials

2,248 Total Patients Enrolled

Rachyl Pines, PhDPrincipal InvestigatorSansum Diabetes Research Insititute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants for this study at the moment?

"Indeed, the data available on clinicaltrials.gov indicates that this trial is currently in the recruitment phase. The study was initially posted for public access on January 31st, 2024 and recently updated on January 11th, 2024. Researchers aim to enroll a total of 30 participants at a single location."

Answered by AI

What is the current number of participants being enrolled in this clinical trial?

"Indeed, the information available on clinicaltrials.gov reveals that this trial is currently seeking eligible individuals. The initial posting of the study occurred on January 31st, 2024, and it was last updated on January 11th, 2024. Recruitment for this trial aims to enroll a total of 30 participants from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes

Rachyl Pines 2024. "Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218147.