Hearty Meals for Mom- Pilot Study of Meal Delivery for Cardiometabolic Health During Pregnancy

Pregnancy Clinical Trial

Official title:

Use of Home-delivered Meals to Manage Cardiometabolic Health During Pregnancy Among Predominantly Black, Low-income Women in Alabama

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05512247
• Other study ID #: IRB-300009764
• Secondary ID: P50MD017338
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: University of Alabama at Birmingham
• Contact: Camille S Worthington, PhD
• Phone: 205-975-7274
• Email: cschneid[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Subjects will receive 10 home-delivered meals per week from about 20 weeks gestation until 40 weeks gestation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Pregnancy

Intervention

Behavioral:
• Meal Delivery
10 home-delivered meals per week provided by a local meal delivery company + brief weekly behavioral support with study staff

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Blood Pressure	Systolic and diastolic blood pressure measured at each prenatal visit will be retrieved from medical records for all participants at the end of the intervention.	First prenatal visit through delivery (Collected once at study end from medical record)
Other	Gestational weight gain	Weight measured at each prenatal visit will be retrieved from medical records for all participants at the end of the intervention and used to calculate total gestational weight gain and rate of gestational weight gain.	First prenatal visit through delivery (Collected once at study end from medical record)
Primary	Change in Healthy Eating Index score from baseline to follow-up	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.	three 24-hour dietary recalls on non-consecutive days at baseline (18-22 weeks gestation) and follow-up (33-37 weeks gestation)
Secondary	Change in Food Security	Determined using the 18-item United States (US) Household Food Security Survey Module based on the previous 30 days. Adult food security scores range from 0 to 10, with lower values indicating greater food security.	baseline (18-22 weeks gestation), (33-37 weeks gestation)
Secondary	Change in Barriers to Healthy Eating	Participants will be asked to score 5 statements corresponding to different barriers to healthy eating on a 5-point Likert scale ranging from strongly agree to strongly disagree (adapted from Sibai D et al. 2022). Changes in the distribution of responses to each barrier will be assessed, as well as changes in the proportion of women somewhat/strongly agreeing with each barrier will be compared.	baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)
Secondary	Study Participation Rate	Percentage of eligible subjects who agreed to participate out of those who were screened.	baseline (18-22 weeks gestation)
Secondary	Participant Retention	The proportion of enrolled participants who complete follow-up	baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)
Secondary	Participant Adherence to Intervention	Proportion of weekly study meals participants consumed based on responses to weekly electronic surveys in which participants will report the number of study meals a) they consumed, b) other household members consumed, or c) that were uneaten.	Collected weekly from intervention start (20-24 weeks gestation) to intervention end (40 weeks gestation)
Secondary	Change in Participant Satisfaction with Diet	To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire will be used in which participants respond to 28 statements using a 5-point Likert scale. Responses are average to produce a total diet satisfaction score ranging from 1-5. Changes in overall diet satisfaction, as well as changes in subscale scores for Cost Factor and Planning & Preparation Factor will be examined from baseline to follow-up.	baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)