Feasibility of Meal Delivery Postpartum

Feasibility of a Meal Delivery Intervention for Postpartum Weight Management

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

Study Overview

• Status: Recruiting
• Conditions: Obesity; Postpartum Weight Retention
• Intervention / Treatment: Behavioral: Meal Delivery

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camille S Worthington, PhD; Phone Number: 205-975-7274; Email: cschneid@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Camille Worthington, PhD; Phone Number: 205-975-7274; Email: cschneid@uab.edu
      • Principal Investigator: Camille S Worthington, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meal Delivery; Meal delivery intervention program designed to help low income postpartum women lose weight through weekly meal delivery and behavioral strategies.	Behavioral: Meal Delivery; 10 home-delivered meals per week provided by a local meal delivery company supplemented by remote weekly behavioral support with study staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Adherence to Intervention	Proportion of weekly study meals participants consumed based on responses to weekly electronic surveys in which participants will report the number of study meals a) they consumed, b) other household members consumed, or c) that were uneaten.	Collected weekly from intervention start (6-21 weeks postpartum) to follow-up (14-29 weeks postpartum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Participation Rate	Percentage of eligible subjects who agreed to participate out of those who were screened	baseline (5-19 weeks postpartum)
Participant Retention	The proportion of enrolled participants who complete follow-up	baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Change in Participant Satisfaction with Diet	To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire will be used in which participants respond to 28 statements using a 5-point Likert scale. Responses are average to produce a total diet satisfaction score ranging from 1-5. Changes in overall diet satisfaction, as well as changes in subscale scores for Cost Factor and Planning & Preparation Factor will be examined from baseline to follow-up.	baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	Body weight measured at baseline and follow-up will be used to calculate weight change.	baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Change in Food Security	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.	baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
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.	baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Change in Healthy Eating Self-Efficacy	Participants will be asked to score 3 statements on a 5-point Likert scale ranging from 1=very sure to 5=very unsure (adapted from Lipsky LM et al. 2016). Responses are reverse coded and averaged, so higher scores reflect increasing self-efficacy.	baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Change in Weight Control Self-Efficacy	Participants will be asked to score 3 statements on a 5-point Likert scale ranging from 1=very sure to 5=very unsure (adapted from Lipsky LM et al. 2016). Responses are reverse coded and averaged, so higher scores reflect increasing self-efficacy.	baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Change in Healthy Eating Index score from baseline to follow-up	Determined based on the Healthy Index Score, in which 100 indicates complete alignment with the Dietary Guidelines for Americans and 0 is the minimum score, as calculated from three 24-hour dietary recalls conducted on non-consecutive days (2 weekdays + 1 weekend day) at each time point.	three 24-hour dietary recalls on non-consecutive days at baseline (5-19 weeks postpartum) and follow-up (14-29 weeks postpartum)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Camille S Worthington, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Postpartum; Weight management; Meal delivery
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: IRB-300010155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after publication of results and ending 36 months following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No