Diet, Healthy, Pregnancy
Conditions
Keywords
Meal Delivery, Maternal Overweight or Obesity, Blood Pressure, Food Security, Pregnancy, Gestational Weight Gain
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.
Interventions
BEHAVIORALMeal Delivery
10 home-delivered meals per week provided by a local meal delivery company + brief weekly behavioral support with study staff
Sponsors
University of Alabama at Birmingham
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
All participants enrolled in the study will receive the meal delivery intervention, so blinding is not possible.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Healthy Eating Index score from baseline to follow-up | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Food Security | 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. |
| Change in Barriers to Healthy Eating | 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. |
| Study Participation Rate | baseline (18-22 weeks gestation) | Percentage of eligible subjects who agreed to participate out of those who were screened. |
| Participant Retention | baseline (18-22 weeks gestation), follow-up (33-37 weeks gestation) | The proportion of enrolled participants who complete follow-up |
| Participant Adherence to Intervention | 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. |
| Change in Participant Satisfaction with Diet | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCamille S Worthington, PhD
University of Alabama at Birmingham
Outcome results
None listed