Pregnancy RelatedHer HOMENCT05605340

Healthier At-home Meals for Expectant Mothers

A study testing Meal Delivery in people with Pregnancy Related and Weight Gain, Maternal, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pregnancy Related, Weight Gain, Maternal
What is being tested?: Meal Delivery
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 9 Aug 2023to 31 Oct 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35294

Other trials in United States

About this study

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

Conditions: Pregnancy Related, Weight Gain, Maternal
Being tested: Meal Delivery
Keywords: Maternal Overweight, Maternal Obesity, Gestational weight gain, Meal delivery
Medical subject headings: Gestational Weight Gain, Pregnancy in Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05605340
Study group	Role	What they receive
Intervention	Experimental	Meal delivery intervention with brief behavioral support. Receives: Behavioral: Meal Delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Weight From First to Last Prenatal Visit
Weight measured at the first and last prenatal visits will be retrieved from medical records for all participants and used to calculate total weight change from the first to the last prenatal visit (i.e., gestational weight gain).
Measured: First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)

Secondary outcomes (4)

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 Food Security was calculated as food security score at follow up minus score at baseline, with negative values indicating an increase in food security from baseline to follow up.
Measured: 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. Change in Perceived Stress score was calculated as score at follow up minus score at baseline, with positive values indicating an increase in perceived stress score from baseline to follow up.
Measured: baseline (12-15 weeks gestation), (35-36 weeks gestation)
Change in Participant Satisfaction With Diet
To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire (DSAT-28) will be used in which participants respond to 28 statements using a 5-point Likert scale. Responses to all 28-items are averaged to produce a total diet satisfaction score (designed to reflect satisfaction as it relates to following a weight-management diet) ranging from 1-5. Subscale scores for Cost Factor (reflects financial cost of the diet) and Planning \& Preparation Factor (reflects amount of time and effort spent in planning and preparing) will also be calculated and range from 1-5. For the overall diet satisfaction score and subscale scores, higher scores represent greater satisfaction. Changes in overall diet satisfaction, as well as changes in subscale scores for Cost Factor and Planning \& Preparation Factor are calculated as score at follow up minus score at baseline, with positive values indicating an increase in satisfaction) from baseline to follow up.
Measured: 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.
Measured: First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Aug 202331 Oct 2025

First posted4 Nov 2022
Study start9 Aug 2023
Primary completion14 Oct 2025
Study completion31 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05605340
Sponsor's protocol ID: IRB-300009275
Other IDs: R21HD107325
Acronym: Her HOME
Status last verified: Oct 2026
First submitted: 25 Oct 2022
Last updated: 4 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Home-delivered Meals to Reduce Excessive Gestational Weight Gain for High-risk Women
ClinicalTrials.gov ID: NCT05605340
Acronym / sponsor ID: Her HOME / IRB-300009275
Conditions: Pregnancy Related, Weight Gain, Maternal
Keywords: Maternal Overweight, Maternal Obesity, Gestational weight gain, Meal delivery
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 9 Aug 2023 (actual)
Primary completion: 14 Oct 2025 (actual)
Study completion: 31 Oct 2025 (actual)
First posted: 4 Nov 2022 (actual)
Results: Posted 4 Nov 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Intervention	Experimental	Behavioral: Meal DeliveryMeal delivery intervention with brief behavioral support.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Meal Delivery10 healthy, home-delivered meals per week + brief weekly remote behavioral support	Behavioural	Intervention

Primary outcome

Change in Weight From First to Last Prenatal Visit
Time frame: First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)
Weight measured at the first and last prenatal visits will be retrieved from medical records for all participants and used to calculate total weight change from the first to the last prenatal visit (i.e., gestational weight gain).

4 secondary outcomes

Change in Food Insecurity
Time frame: baseline (12-15 weeks gestation), (35-36 weeks gestation)
Change in Perceived Stress
Time frame: baseline (12-15 weeks gestation), (35-36 weeks gestation)
Change in Participant Satisfaction With Diet
Time frame: baseline (12-15 weeks gestation), (35-36 weeks gestation)
Proportion of Women Exceeding Institute of Medicine Gestational Weight Gain Guidelines
Time frame: First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)

Results and safety

Results posted to the registry on 4 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Meal Delivery Intervention	35	34

Primary outcome: Change in Weight From First to Last Prenatal Visit

Time frame: First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation). Mean (Standard Deviation). Unit: pounds

Measure	Meal Delivery Intervention n = 34
Value	28.3 (15.7)

Population analysed: One participant relocated during the study and weight information at their last prenatal care visit was unable to be obtained. Therefore, we could not calculate gestational weight gain for this participant and the total analyzed for this outcome is 34 participants.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of meal delivery intervention at 40 weeks gestation, up to 27 weeks. Adverse event data were collected via weekly electronic surveys sent each week during the intervention.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Meal Delivery Intervention	6 of 35 (17.1%)	7 of 35 (20%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gareth Dutton, PhD principal investigator

University of Alabama at Birmingham

Camille Worthington, PhD principal investigator

University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Meal Delivery in people with Pregnancy Related and Weight Gain, Maternal, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight From First to Last Prenatal Visit (time frame: First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05605340.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.