Clinical trial NCT05605340: Healthier At-home Meals for Expectant Mothers
Official title: Use of Home-delivered Meals to Reduce Excessive Gestational Weight Gain for High-risk Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Weight Gain, Maternal
Keywords: Maternal Overweight
Maternal Obesity
Gestational weight gain
Meal delivery
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in weight from first to last prenatal visit
timeFrame: First prenatal visit (<15 weeks gestation), last prenatal visit (35+ weeks gestation)
Secondary outcomes:
measure: Change in Food Insecurity
timeFrame: baseline (12-15 weeks gestation), (35-36 weeks gestation)
measure: Change in Perceived Stress
timeFrame: baseline (12-15 weeks gestation), (35-36 weeks gestation)
measure: Change in Participant Satisfaction with Diet
timeFrame: baseline (12-15 weeks gestation), (35-36 weeks gestation)
measure: Proportion of Women Exceeding Institute of Medicine Gestational Weight Gain Guidelines
timeFrame: First prenatal visit (<15 weeks gestation), last prenatal visit (35+ weeks gestation)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Gareth Dutton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Camille Worthington, PhD
role: PRINCIPAL_INVESTIGATOR
References: