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Healthier At-home Meals for Expectant Mothers (Her HOME)

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Active, not recruiting

Conditions

Pregnancy Related
Weight Gain, Maternal

Treatments

Behavioral: Meal Delivery

Study type

Interventional

Funder types

Other

Identifiers

NCT05605340
R21HD107325 (U.S. NIH Grant/Contract)
IRB-300009275

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Intervention
Experimental group
Description:
Meal delivery intervention with brief behavioral support.
Treatment:
Behavioral: Meal Delivery

Trial contacts and locations

1

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Central trial contact

Amy Dobelstein; Olivia Krantz

Data sourced from clinicaltrials.gov

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