Healthier At-home Meals for Expectant Mothers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-09

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pregnancy Related Weight Gain, Maternal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

All participants enrolled will receive the study intervention, so blinding is not possible.

Study Groups

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Intervention

Meal delivery intervention with brief behavioral support.

Group Type EXPERIMENTAL

Meal Delivery

Intervention Type BEHAVIORAL

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

Interventions

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Meal Delivery

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No