Hearty Meals for Mom- Pilot Study of Meal Delivery for Cardiometabolic Health During Pregnancy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Subjects will receive 10 home-delivered meals per week from about 20 weeks gestation until 40 weeks gestation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Meal Delivery 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Other Outcome Measures
- Change in Blood Pressure [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.
- Gestational weight gain [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Medicaid eligible and/or have a household income at or below 185 percent of the federal poverty line
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18 years of age or older
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<= 19 weeks gestation
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Currently experiencing a singleton pregnancy
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Receiving prenatal care at a University of Alabama at Birmingham clinic
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Planning to deliver at the University of Alabama at Birmingham
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Residing within the meal company's delivery radius
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Body mass index >= 25
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Willing to consent
Exclusion Criteria:
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Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 2 diabetes)
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Current treatment for severe psychiatric disorder (such as schizophrenia)
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Current substance abuse
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Self-reported diagnosis of anorexia or bulimia
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Known fetal anomaly
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Current use of medication expected to significantly impact body weight
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Planned termination of the current pregnancy
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Participation in another dietary and/or weight management intervention during the current pregnancy
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Unwilling or unable to understand and communicate in English
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Unwilling or unable to consume study meals
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
- Principal Investigator: Camille S Worthington, PhD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-300009764