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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Related; Weight Gain, Maternal
• Intervention / Treatment: Behavioral: Meal Delivery

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Gareth Dutton, PhD, University of Alabama at Birmingham; Principal Investigator: Camille Worthington, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Actual): October 14, 2025
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Gestational weight gain; Maternal Obesity; Maternal Overweight; Meal delivery
• Additional Relevant MeSH Terms: Urogenital Diseases; Nutrition Disorders; Female Urogenital Diseases and Pregnancy Complications; Overnutrition; Body Weight; Pregnancy Complications; Body Weight Changes; Overweight; Obesity; Weight Gain; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Gestational Weight Gain; Pregnancy in Obesity
• Other Study ID Numbers: IRB-300009275; R21HD107325 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) that underlie the results reported in a publication will be made available upon request beginning 9 months and ending 36 months following article publication. The research team will keep a record of all individuals and/or research teams who request and receive a copy of the project data. Interested investigators will be asked to submit a document indicating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after publication of results and ending 36 months following article publication.
• IPD Sharing Access Criteria: Access to IPD stripped of all HIPAA identifiers (except age) for this study can be requested by qualified researchers engaging in independent scientific research whose proposed research has received Institutional Review Board approval, and will be provided following review and approval of a research proposal and timeline, statistical analysis plan, and goals (e.g., manuscripts, presentations, grant applications). The Principal Investigator (PI) and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed. Based on institutional policies, execution of a Data Sharing Agreement may be required prior to sharing of IPD. IPD requests can be made to the MPIs at gdutton@uabmc.edu or cschneid@uab.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No