Hearty Meals for Mom- Pilot Study of Meal Delivery for Cardiometabolic Health During Pregnancy (NCT05512247) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Hearty Meals for Mom- Pilot Study of Meal Delivery for Cardiometabolic Health During Pregnancy
United States17 participantsStarted 2023-10-05
Plain-language summary
This study is being done to assess the feasibility, acceptability, and preliminary impact of a meal delivery intervention designed to improve diet quality and promote appropriate gestational weight gain among predominantly Black and low-income pregnant women with overweight or obesity. This will be done by 1) assessing the feasibility and acceptability of the meal delivery intervention; 2) investigating changes in patient-reported diet quality, barriers to healthy eating, and food security; and 3) exploring the preliminary impact of the meal delivery intervention on gestational weight gain and blood pressure and estimate the effect size of the intervention relative to a de-identified non-randomized control group that will be derived from de-identified hospital records.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Medicaid eligible and/or have a household income at or below 185 percent of the federal poverty line
* 18 years of age or older
* \<= 19 weeks gestation
* Currently experiencing a singleton pregnancy
* Receiving prenatal care at a University of Alabama at Birmingham clinic
* Planning to deliver at the University of Alabama at Birmingham
* Residing within the meal company's delivery radius
* Body mass index \>= 25
* Willing to consent
Exclusion Criteria:
* Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 2 diabetes)
* Current treatment for severe psychiatric disorder (such as schizophrenia)
* Current substance abuse
* Self-reported diagnosis of anorexia or bulimia
* Known fetal anomaly
* Current use of medication expected to significantly impact body weight
* Planned termination of the current pregnancy
* Participation in another dietary and/or weight management intervention during the current pregnancy
* Unwilling or unable to understand and communicate in English
* Unwilling or unable to consume study meals
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Healthy Eating Index score from baseline to follow-up
Timeframe: three 24-hour dietary recalls on non-consecutive days at baseline (18-22 weeks gestation) and follow-up (33-37 weeks gestation)