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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
17
10 home-delivered meals per week provided by a local meal delivery company + brief weekly behavioral support with study staff
University of Alabama at Birmingham
Birmingham, Alabama, United States
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)
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