Healthier At-home Meals for Expectant Mothers

Study Overview
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Brief Summary
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This study is being done to test the feasibility, acceptability, and preliminary efficacy of a meal delivery intervention for managing gestational weight gain among pregnant women with overweight or obesity.

Official Title
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Use of Home-delivered Meals to Reduce Excessive Gestational Weight Gain for High-risk Women

Conditions
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Pregnancy Related, Weight Gain, Maternal

Intervention / Treatment
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* Behavioral: Meal Delivery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Gestational age ≤ 15 weeks as assessed by ultrasound Body mass index (BMI) ≥ 25 kg/m2 Singleton viable pregnancy Receiving care and planning to deliver at UAB Residing within the delivery radius of the meal delivery company Wi-Fi or Bluetooth Internet connection in home (for digital Wi-Fi enabled study scale) Exclusion Criteria: Self-reported major health conditions (e.g., heart disease, cancer, renal disease, and Type 1 or Type 2 diabetes) Current substance abuse Current treatment for serious psychiatric disorder (schizophrenia, bipolar disorder) Known fetal anomaly Planned termination of pregnancy Past history or current diagnosis of anorexia or bulimia Current use of one or more of the following medications: Metformin Systemic steroids Antipsychotic agents Anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight Medications for ADHD including amphetamines and methylphenidate Any teratogenic agent Class D Participation in another dietary and/or weight management intervention during pregnancy Unwilling or unable to consume prepared meals delivered weekly Unable to understand and communicate in verbal and written English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: All participants enrolled will receive the study intervention. A quasi-experimental design will be used to investigate the preliminary efficacy of the meal delivery intervention on gestational weight gain and estimate the effect size of the intervention relative to a non-randomized standard care but weighted control group derived from de-identified hospital records.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Meal delivery intervention with brief behavioral support. | Behavioral: Meal Delivery<br>* 10 healthy, home-delivered meals per week + brief weekly remote behavioral support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight from first to last prenatal visit | Weight measured at each prenatal visit will be retrieved from medical records for all participants and used to model total weight change from the first to the last prenatal visit (i.e., gestational weight gain). | First prenatal visit (<15 weeks gestation), last prenatal visit (35+ weeks gestation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Food Insecurity | 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. | baseline (12-15 weeks gestation), (35-36 weeks gestation) | 
| Change in Perceived Stress | Determined using the 10-item Perceived Stress Scale (PSS-10) based on the last month. PSS-10 scores range from 0 to 40, with higher scores representing higher levels of perceived stress. | baseline (12-15 weeks gestation), (35-36 weeks gestation) | 
| Change in Participant Satisfaction with Diet | Determined using the 28-item Diet Satisfaction Questionnaire 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. | baseline (12-15 weeks gestation), (35-36 weeks gestation) | 
| Proportion of Women Exceeding Institute of Medicine Gestational Weight Gain Guidelines | Weight at the first prenatal visit will be subtracted from weight at the last prenatal visit. Women will be categorized as exceeding 2009 Institute of Medicine gestational weight gain guidelines if the difference is > 11.5 kg gain for women with overweight or >9 kg for women with obesity at the first prenatal visit. | First prenatal visit (<15 weeks gestation), last prenatal visit (35+ weeks gestation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal Overweight, Maternal Obesity, Gestational weight gain, Meal delivery