Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445530
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-31
Brief Title:
Nutrition Optimization and Community Upliftment for Postpartum Recovery
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Nutrition Optimization and Community Upliftment for Postpartum Recovery Interventions to Support Healing After Gestational Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOURISH-GDM
Brief Summary:
The goal of this clinical trial is to better understand how different strategies timing and enhancements to medically tailored food delivery will address structural inequities in the food environment empower communities to sustain behavior change and ultimately improve postpartum weight control to prevent type 2 diabetes-a potent contributor to disparate mortality among Black women
The main aims of the study are
To conduct a pilot randomized control trial to test the feasibility acceptability and effectiveness of a multi-component Medically Tailored Food MTF intervention Moveable Feast ENHANCED a hybrid MTF intervention with a patient-activated change from prepared meals to fresh food delivery customized for postpartum people culturally customized for engagement and adherence and food provision for dependents versus MFeast Usual Care prepared medically tailored foods only
To test sustainability and scalability
Participants will
Respond to online surveys supported by study team members via scheduled phone calls via REDCap links shared before each study visit at baseline 3 6 months post-delivery after the baseline survey
Submit anthropometric data ie weight and information about laboratory results eg HgbA1C
The main aims of the study are
To conduct a pilot randomized control trial to test the feasibility acceptability and effectiveness of a multi-component Medically Tailored Food MTF intervention Moveable Feast ENHANCED a hybrid MTF intervention with a patient-activated change from prepared meals to fresh food delivery customized for postpartum people culturally customized for engagement and adherence and food provision for dependents versus MFeast Usual Care prepared medically tailored foods only
To test sustainability and scalability
Participants will
Respond to online surveys supported by study team members via scheduled phone calls via REDCap links shared before each study visit at baseline 3 6 months post-delivery after the baseline survey
Submit anthropometric data ie weight and information about laboratory results eg HgbA1C
Detailed Description:
This study will evaluate the feasibility acceptability and preliminary effectiveness of a postpartum dietary intervention for Black women with obesity and a recent pregnancy complicated by gestational diabetes mellitus GDM The investigators will recruit women through Medicaid insurance plans Priority Partners clinical obstetric practice Johns Hopkins Outpatient Center Womens Health Center perinatal community-based organizations MOM Cares and Bloom Collective and home-visiting locations The Family Tree of Maryland-all of which can verify clinical outcomes for participants
At 37 weeks gestation participants are contacted by the study team for consent baseline data collection baseline visit 1 and randomization 11 to receive the intervention vs usual care which begins in the first postpartum week 3-7 days after randomization the remainder of baseline visit information baseline visit 2 is collected including information for the prepared MTF vendor Moveable Feast Baltimore
The intervention group will initially receive prepared MTF low carbohydrate and low-fat meals which have been shown to improve glycemia in people with prediabetes delivered by Moveable Feast MFeast 10 meals weekly Tailored Medical Nutrition Therapy MNT delivered by dieticians from MFeast via monthly phone calls and focused on two high yield topics only sugar-sweetened beverages and fruit and vegetable consumption Lactation nutritional snack bundles to boost milk supply structural support for breastfeeding pumping via lactation consultants and pumping supply subsidization culturally-adapted seasoning bundles and dependent meal boxes for children in the household ie will include 10 developmentally appropriate snack and small meal bundles for up to 24 weeks At postpartum week 8 participants will be offered a transition from prepared medically tailored meals to Instacart fresh food delivery medically tailored via study team-crafted virtual grocery store for 16 more weeks
Those assigned to the MFeast Usual Care group will receive prepared MTF delivered by MFeast and as-needed MNT from 1 to 24 weeks postpartum
At 37 weeks gestation participants are contacted by the study team for consent baseline data collection baseline visit 1 and randomization 11 to receive the intervention vs usual care which begins in the first postpartum week 3-7 days after randomization the remainder of baseline visit information baseline visit 2 is collected including information for the prepared MTF vendor Moveable Feast Baltimore
The intervention group will initially receive prepared MTF low carbohydrate and low-fat meals which have been shown to improve glycemia in people with prediabetes delivered by Moveable Feast MFeast 10 meals weekly Tailored Medical Nutrition Therapy MNT delivered by dieticians from MFeast via monthly phone calls and focused on two high yield topics only sugar-sweetened beverages and fruit and vegetable consumption Lactation nutritional snack bundles to boost milk supply structural support for breastfeeding pumping via lactation consultants and pumping supply subsidization culturally-adapted seasoning bundles and dependent meal boxes for children in the household ie will include 10 developmentally appropriate snack and small meal bundles for up to 24 weeks At postpartum week 8 participants will be offered a transition from prepared medically tailored meals to Instacart fresh food delivery medically tailored via study team-crafted virtual grocery store for 16 more weeks
Those assigned to the MFeast Usual Care group will receive prepared MTF delivered by MFeast and as-needed MNT from 1 to 24 weeks postpartum
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None