Clinical trial NCT05512247: Hearty Meals for Mom- Pilot Study of Meal Delivery for Cardiometabolic Health During Pregnancy
Official title: Use of Home-delivered Meals to Manage Cardiometabolic Health During Pregnancy Among Predominantly Black, Low-income Women in Alabama
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diet, Healthy
Pregnancy
Keywords: Meal Delivery
Maternal Overweight or Obesity
Blood Pressure
Food Security
Pregnancy
Gestational Weight Gain
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-08-23
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the meal delivery intervention to examine feasibility metrics (e.g., recruitment, attrition, adherence, safety) and pre-post intervention changes. A quasi-experimental design utilizing a comparison group derived from de-identified hospital records will be used for exploratory analyses of intervention impact on gestational weight gain and blood pressure compared to standard care.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Change in Food Security
timeFrame: baseline (18-22 weeks gestation), (33-37 weeks gestation)
measure: Change in Barriers to Healthy Eating
timeFrame: baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)
measure: Study Participation Rate
timeFrame: baseline (18-22 weeks gestation)
measure: Participant Retention
timeFrame: baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)
measure: Participant Adherence to Intervention
timeFrame: Collected weekly from intervention start (20-24 weeks gestation) to intervention end (40 weeks gestation)
measure: Change in Participant Satisfaction with Diet
timeFrame: baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)
Other outcomes:
measure: Change in Blood Pressure
timeFrame: First prenatal visit through delivery (Collected once at study end from medical record)
measure: Gestational weight gain
timeFrame: First prenatal visit through delivery (Collected once at study end from medical record)
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Camille S Worthington, PhD
role: PRINCIPAL_INVESTIGATOR
References: