An interventional study of Meal Delivery in Diet, Healthy and Pregnancy, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
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.
Subjects will receive 10 home-delivered meals per week from about 20 weeks gestation until 40 weeks gestation.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 17 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Meal Delivery
10 home-delivered meals per week provided by a local meal delivery company + brief weekly behavioral support with study staff
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.
Time frame: three 24-hour dietary recalls on non-consecutive days at baseline (18-22 weeks gestation) and follow-up (33-37 weeks gestation)
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.
Time frame: baseline (18-22 weeks gestation), (33-37 weeks gestation)
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.
Time frame: baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)
Study Participation Rate
Percentage of eligible subjects who agreed to participate out of those who were screened.
Time frame: baseline (18-22 weeks gestation)
Participant Retention
The proportion of enrolled participants who complete follow-up
Time frame: baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)
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.
Time frame: Collected weekly from intervention start (20-24 weeks gestation) to intervention end (40 weeks gestation)
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.
Time frame: baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation)
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.
Time frame: First prenatal visit through delivery (Collected once at study end from medical record)
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.
Time frame: First prenatal visit through delivery (Collected once at study end from medical record)
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in a publication will be made available upon request beginning 9 months and ending 36 months following article publication. The research team will keep a record of all individuals and/or research teams who request and receive a copy of the project data. Interested investigators will be asked to submit a document indicating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed.
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham