Use of Home-delivered Meals to Manage Cardiometabolic Health During Pregnancy Among Predominantly Black, Low-income Women in Alabama
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Change in Healthy Eating Index score from baseline to follow-up
Study Overview
Brief 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.
Detailed Description
Subjects will receive 10 home-delivered meals per week from about 20 weeks gestation until 40 weeks gestation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
All participants enrolled in the study will receive the meal delivery intervention, so blinding is not possible.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Meal Delivery
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.
Intervention: Meal Delivery (Behavioral)
Outcomes
Primary Outcomes
Change in Healthy Eating Index score from baseline to follow-up
Time Frame: three 24-hour dietary recalls on non-consecutive days at baseline (18-22 weeks gestation) and follow-up (33-37 weeks gestation)
Determined based on the Healthy Index Score, in which 100 indicates complete alignment with the Dietary Guidelines for Americans and 0 is the minimum score, as calculated from three 24-hour dietary recalls conducted on non-consecutive days (2 weekdays + 1 weekend day) at each time point.
Secondary Outcomes
- Change in Food Security(baseline (18-22 weeks gestation), (33-37 weeks gestation))
- Study Participation Rate(baseline (18-22 weeks gestation))
- Change in Participant Satisfaction with Diet(baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation))
- Participant Retention(baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation))
- Change in Barriers to Healthy Eating(baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation))
- Participant Adherence to Intervention(Collected weekly from intervention start (20-24 weeks gestation) to intervention end (40 weeks gestation))
Investigators
Camille S Worthington, PhD
Primary Investigator
University of Alabama at Birmingham