Healthier At-home Meals for Expectant Mothers
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.
Conditions:
🦠 Pregnancy Related 🦠 Weight Gain, Maternal
🗓️ Study Start (Actual) 9 August 2023
🗓️ Primary Completion (Estimated) 31 May 2025
✅ Study Completion (Estimated) 31 May 2026
👥 Enrollment (Estimated) 35
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Birmingham, Alabama, United States

📋 Eligibility Criteria

Description

    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: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 October 2022
  • First Submitted that Met QC Criteria 28 October 2022
  • First Posted 4 November 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 August 2023
  • Last Update Posted 15 August 2023
  • Last Verified August 2023