Healthier At-home Meals for Expectant Mothers

NCT05605340 | Active Not Recruiting

• 2 other identifiers: IRB-300009275R21HD107325
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Maternal Overweight; Maternal Obesity; Gestational weight gain; Meal delivery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Food Insecurity

  baseline (12-15 weeks gestation), (35-36 weeks gestation)

• Change in Perceived Stress

  baseline (12-15 weeks gestation), (35-36 weeks gestation)

• Change in Participant Satisfaction with Diet

  baseline (12-15 weeks gestation), (35-36 weeks gestation)

• Proportion of Women Exceeding Institute of Medicine Gestational Weight Gain Guidelines

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

Study Arms (1)

Intervention

EXPERIMENTAL

Meal delivery intervention with brief behavioral support.

Behavioral: Meal Delivery

Interventions

Meal Delivery BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Gestational Weight Gain; Pregnancy in Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Gareth Dutton, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Camille Worthington, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants enrolled will receive the study intervention, so blinding is not possible.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 4, 2022
• Study Start: August 9, 2023
• Primary Completion: October 14, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests can be submitted starting 9 months after publication of results and ending 36 months following article publication.
• 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.

Locations

US (1)