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Meal Delivery for Healthy Eating During Pregnancy
N/A
Recruiting
Led By Camille S Worthington, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (18-22 weeks gestation), (33-37 weeks gestation)
Awards & highlights
Study Summary
This trial is testing whether a meal delivery intervention can help improve diet quality and promote appropriate gestational weight gain among pregnant women who are overweight or obese.
Who is the study for?
This trial is for Black and low-income pregnant women with overweight or obesity who are Medicaid eligible, have a household income below 185% of the federal poverty line, aged 18+, less than 19 weeks into a singleton pregnancy, planning to deliver at UAB, living within the meal delivery area, and willing to consent. Excluded are those unwilling/unable to eat study meals or communicate in English, on weight-impacting meds, with severe health conditions or psychiatric disorders.Check my eligibility
What is being tested?
The study tests if delivering healthy meals can improve diet quality and manage weight gain during pregnancy. It will check how feasible and acceptable this service is among participants; measure changes in their eating habits; assess impacts on gestational weight gain and blood pressure; compare results against data from similar patients not receiving the intervention.See study design
What are the potential side effects?
Since this trial involves meal delivery rather than medication or medical procedures, there aren't typical side effects as seen in drug trials. However, dietary changes may cause digestive adjustments or food sensitivities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three 24-hour dietary recalls on non-consecutive days at baseline (18-22 weeks gestation) and follow-up (33-37 weeks gestation)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three 24-hour dietary recalls on non-consecutive days at baseline (18-22 weeks gestation) and follow-up (33-37 weeks gestation)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Healthy Eating Index score from baseline to follow-up
Secondary outcome measures
Change in Barriers to Healthy Eating
Change in Food Security
Change in Participant Satisfaction with Diet
+3 moreOther outcome measures
Change in Blood Pressure
Gestational weight gain
Trial Design
1Treatment groups
Experimental Treatment
Group I: Meal DeliveryExperimental Treatment1 Intervention
Behavioral intervention program designed to improve diet quality and promote healthy weight gain in women with overweight/obesity through meal delivery and behavioral strategies during pregnancy.
Find a Location
Who is running the clinical trial?
National Institute on Minority Health and Health Disparities (NIMHD)NIH
376 Previous Clinical Trials
1,215,138 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,573 Previous Clinical Trials
2,273,261 Total Patients Enrolled
Camille S Worthington, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant with only one baby.I am less than 19 weeks pregnant.I am taking medication that can greatly affect my weight.I am 18 years old or older.I have a major health condition like kidney disease, cancer, or diabetes.I cannot communicate in English.I am not currently being treated for a severe psychiatric disorder like schizophrenia.I cannot or will not eat the meals provided by the study.I have been diagnosed with anorexia or bulimia.You are currently pregnant with only one baby.You are overweight, with a body mass index of 25 or higher.I am less than 19 weeks pregnant.You are willing to give permission to participate in the study.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Meal Delivery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there availability to participate in this experiment?
"As displayed on clinicaltrials.gov, this study is not recruiting at the moment. Originally posted on January 1st 2023 and last amended October 31st 2022, it has yet to attract participants. However, there are currently 144 other medical trials actively enlisting patients worldwide."
Answered by AI
Who else is applying?
What state do they live in?
Mississippi
Alabama
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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