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

Primary Purpose

Pregnancy Related, Weight Gain, Maternal

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal Delivery
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Related focused on measuring Maternal Overweight, Maternal Obesity, Gestational weight gain, Meal delivery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Meal delivery intervention with brief behavioral support.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 25, 2022
Last Updated
August 14, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05605340
Brief Title
Healthier At-home Meals for Expectant Mothers
Acronym
Her HOME
Official Title
Use of Home-delivered Meals to Reduce Excessive Gestational Weight Gain for High-risk Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2023 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Weight Gain, Maternal
Keywords
Maternal Overweight, Maternal Obesity, Gestational weight gain, Meal delivery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
All participants enrolled will receive the study intervention, so blinding is not possible.
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Meal delivery intervention with brief behavioral support.
Intervention Type
Behavioral
Intervention Name(s)
Meal Delivery
Intervention Description
10 healthy, home-delivered meals per week + brief weekly remote behavioral support
Primary Outcome Measure Information:
Title
Change in weight from first to last prenatal visit
Description
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).
Time Frame
First prenatal visit (<15 weeks gestation), last prenatal visit (35+ weeks gestation)
Secondary Outcome Measure Information:
Title
Change in Food Insecurity
Description
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.
Time Frame
baseline (12-15 weeks gestation), (35-36 weeks gestation)
Title
Change in Perceived Stress
Description
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.
Time Frame
baseline (12-15 weeks gestation), (35-36 weeks gestation)
Title
Change in Participant Satisfaction with Diet
Description
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.
Time Frame
baseline (12-15 weeks gestation), (35-36 weeks gestation)
Title
Proportion of Women Exceeding Institute of Medicine Gestational Weight Gain Guidelines
Description
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.
Time Frame
First prenatal visit (<15 weeks gestation), last prenatal visit (35+ weeks gestation)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Dobelstein
Phone
205-975-1059
Email
adobelst@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Krantz
Phone
205-934-3362
Email
omkrantz@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gareth Dutton, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Camille Worthington, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Dobelstein
Phone
205-975-1059
Email
adobelst@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Camille Worthington
Phone
205-975-7274
Email
cschneid@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Healthier At-home Meals for Expectant Mothers

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