Clinical trial NCT05579990: Feasibility of Meal Delivery Postpartum
Official title: Feasibility of a Meal Delivery Intervention for Postpartum Weight Management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postpartum Weight Retention
Obesity
Keywords: Postpartum
Weight management
Meal delivery
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-10-14
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is being done to assess the feasibility and acceptability of a meal delivery intervention among low-income postpartum women with obesity.

Detailed description: This is a single-group pilot study in which subjects will receive 10 home-delivered meals per week for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Medicaid eligible and/or have a household income at or below 185 percent of the federal poverty line
* 18 years of age or older
* Initiated prenatal care at a University of Alabama at Birmingham prenatal clinic
* Experienced a healthy singleton pregnancy
* 5-18 weeks postpartum at enrollment
* Body mass index \>= 30 at enrollment
* Residing within the meal company's delivery radius
* Willing to consent

Exclusion Criteria:

* Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 2 diabetes)
* Current treatment for severe psychiatric disorder (such as schizophrenia)
* Self-reported diagnosis of anorexia or bulimia
* Current use of medication expected to significantly impact body weight
* Current substance abuse
* Participation in another dietary and/or weight management intervention postpartum
* Unable to understand and communicate in English
* Unwilling or unable to consume study meals

Primary outcomes:
measure: Participant Adherence to Intervention
timeFrame: Collected weekly from intervention start (6-21 weeks postpartum) to follow-up (14-29 weeks postpartum)
Secondary outcomes:
measure: Study Participation Rate
timeFrame: baseline (5-19 weeks postpartum)
measure: Participant Retention
timeFrame: baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
measure: Change in Participant Satisfaction with Diet
timeFrame: baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Other outcomes:
measure: Change in Weight
timeFrame: baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
measure: Change in Food Security
timeFrame: baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
measure: Change in Perceived Stress
timeFrame: baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
measure: Change in Healthy Eating Self-Efficacy
timeFrame: baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
measure: Change in Weight Control Self-Efficacy
timeFrame: baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
measure: Change in Healthy Eating Index score from baseline to follow-up
timeFrame: three 24-hour dietary recalls on non-consecutive days at baseline (5-19 weeks postpartum) and follow-up (14-29 weeks postpartum)
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Camille S Worthington, PhD
role: PRINCIPAL_INVESTIGATOR
References: