Medically Tailored Meals for Gestational Weight Gain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Wake Forest Baptist Health, Winston-Salem, NCGestational Weight Gain+4 MoreMedically Tailored Meals - Behavioral
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing whether medically tailored meals can help reduce high blood sugar after delivery in post-partum women with a history of gestational diabetes.

Eligible Conditions
  • Gestational Weight Gain
  • Gestational Diabetes
  • Postpartum Weight Retention

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

4 Primary · 6 Secondary · Reporting Duration: 3 months

3 months
Acceptability of Study Measures
Days of Continuous Glucose Monitoring in Postpartum Mothers
Feasibility of Medically Tailored Meals in Postpartum Mothers: Cost per Participant
Feasibility of Medically Tailored Meals in Postpartum Mothers: Percent of meals successfully Ordered and Delivered
Baseline and month 3
Change in Glucose Management Indicator (GMI)
Change in Glycemic Variability
Change in Mean Glucose
Change in Time Above Range (Hyperglycemia)
Hypoglycemia
Change in Time in Range (TIR)

Trial Safety

Safety Progress

1 of 3

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1
FreshRx Nourishing Healthy Starts
1
Healthy for Two/Healthy for You
1
Healthy Beginnings

Trial Design

2 Treatment Groups

Usual Care Comparison Group
1 of 2
Medically Tailored Meals
1 of 2

Active Control

Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: Medically Tailored Meals · No Placebo Group · N/A

Medically Tailored Meals
Behavioral
Experimental Group · 1 Intervention: Medically Tailored Meals · Intervention Types: Behavioral
Usual Care Comparison GroupNoIntervention Group · 1 Intervention: Usual Care Comparison Group · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medically Tailored Meals
2020
N/A
~700

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,146 Previous Clinical Trials
1,140,511 Total Patients Enrolled
North Carolina Diabetes Research CenterUNKNOWN
1 Previous Clinical Trials
14 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,382 Previous Clinical Trials
3,930,192 Total Patients Enrolled
1 Trials studying Gestational Weight Gain
371 Patients Enrolled for Gestational Weight Gain
Morgana Mongraw-ChaffinPrincipal InvestigatorWake Forest University Health Sciences

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

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References

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