Feasibility of Meal Delivery Postpartum

NCT05579990 | Completed Results

• 2 other identifiers: IRB-300010155U54MD000502
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Weight Retention; Obesity

Keywords

Postpartum; Weight management; Meal delivery

Outcome Measures

Primary Outcomes (1)

• Self-Reported Proportion of Received Study Meals Consumed

  Proportion of received weekly study meals participants reported consuming each week collected via weekly electronic surveys in which participants will self-report the number of study meals a) they consumed, b) other household members consumed, or c) that were uneaten.

  Collected weekly from intervention start (6-45 weeks postpartum) to follow-up (14-53 weeks postpartum)

Secondary Outcomes (3)

• Study Participation Rate

  baseline (5-45 weeks postpartum)

• Participant Retention

  baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)

• Change in Participant Satisfaction With Diet

  baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)

Other Outcomes (5)

• Change in Weight

  baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)

• Change in Food Security

  baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)

• Change in Perceived Stress

  baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)

Study Arms (1)

Meal Delivery

EXPERIMENTAL

Meal delivery intervention program designed to help low income postpartum women lose weight through weekly meal delivery and behavioral strategies.

Behavioral: Meal Delivery

Interventions

Meal Delivery BEHAVIORAL

10 home-delivered meals per week provided by a local meal delivery company supplemented by remote weekly behavioral support with study staff.

Meal Delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Gestational Weight Gain; Obesity

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Camille Worthington
• Organization: University of Alabama at Birmingham

cschneid@uab.edu

205-975-7274

Study Officials

• Camille S Worthington, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants enrolled in the study will receive the meal delivery intervention, so blinding is not possible.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: September 27, 2023
• Primary Completion: July 29, 2024
• Study Completion: September 11, 2025
• Last Updated: September 23, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests can be submitted starting 9 months after publication of results and ending 36 months following article publication.
• 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 PI at cschneid@uab.edu.

Locations

US (1)