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NCT Number: NCT05605340

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pregnancy Related Body Weight Body Weight Changes Female Urogenital Diseases and Pregnancy Complications Gestational Weight Gain Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy in Obesity Signs and Symptoms Urogenital Diseases Weight Gain Weight Gain, Maternal

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal Delivery

Behavioral

10 healthy, home-delivered meals per week + brief weekly remote behavioral support

Primary outcomes

  1. Change in weight from first to last prenatal visit

    Time frame: First prenatal visit (<15 weeks gestation), last prenatal visit (35+ weeks gestation)

    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).

Secondary outcomes

  1. Change in Food Insecurity

    Time frame: baseline (12-15 weeks gestation), (35-36 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.

  2. Change in Perceived Stress

    Time frame: baseline (12-15 weeks gestation), (35-36 weeks gestation)

    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.

  3. Change in Participant Satisfaction with Diet

    Time frame: baseline (12-15 weeks gestation), (35-36 weeks gestation)

    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.

  4. Proportion of Women Exceeding Institute of Medicine Gestational Weight Gain Guidelines

    Time frame: First prenatal visit (<15 weeks gestation), last prenatal visit (35+ weeks gestation)

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: Her HOME

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 4, 2022
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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