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Completed

NCT Number: NCT05512247

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

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.

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Key information

Conditions

Diet, Healthy Body Weight Body Weight Changes Gestational Weight Gain Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal Delivery

Behavioral

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

Primary outcomes

  1. 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

  1. Change in Food Security

    Time frame: baseline (18-22 weeks gestation), (33-37 weeks gestation)

    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.

  2. Change in Barriers to Healthy Eating

    Time frame: baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)

    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.

  3. Study Participation Rate

    Time frame: baseline (18-22 weeks gestation)

    Percentage of eligible subjects who agreed to participate out of those who were screened.

  4. Participant Retention

    Time frame: baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)

    The proportion of enrolled participants who complete follow-up

  5. Participant Adherence to Intervention

    Time frame: Collected weekly from intervention start (20-24 weeks gestation) to intervention end (40 weeks gestation)

    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.

  6. Change in Participant Satisfaction with Diet

    Time frame: baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)

    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.

Other outcomes

  1. Change in Blood Pressure

    Time frame: First prenatal visit through delivery (Collected once at study end from medical record)

    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.

  2. Gestational weight gain

    Time frame: First prenatal visit through delivery (Collected once at study end from medical record)

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2022
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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