Healthier At-home Meals for Expectant Mothers

Not Applicable

Active, not recruiting

• Conditions: Pregnancy Related; Weight Gain, Maternal
• Interventions: Behavioral: Meal Delivery

• Registration Number: NCT05605340
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-04
• Study Start: 2023-08-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Meal Delivery	Meal delivery intervention with brief behavioral support.

Primary Outcome Measures

Name	Time	Method
Change in weight from first to last prenatal visit	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 Outcome Measures

Name	Time	Method
Change in Food Insecurity	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.
Change in Perceived Stress	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.
Change in Participant Satisfaction with Diet	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.
Proportion of Women Exceeding Institute of Medicine Gestational Weight Gain Guidelines	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States