Healthier At-home Meals for Expectant Mothers

Pregnancy Related Clinical Trial

— Her HOME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05605340
• Other study ID #: IRB-300009275
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: August 2023
• Source: University of Alabama at Birmingham
• Contact: Amy Dobelstein
• Phone: 205-975-1059
• Email: adobelst[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gestational Weight Gain
• Pregnancy Related
• Weight Gain
• Weight Gain, Maternal

Intervention

Behavioral:
• Meal Delivery
10 healthy, home-delivered meals per week + brief weekly remote behavioral support

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)