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Feasibility of Meal Delivery Postpartum

Primary Purpose

Postpartum Weight Retention, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal Delivery
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postpartum Weight Retention focused on measuring Postpartum, Weight management, Meal delivery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Meal Delivery

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Study Participation Rate
Percentage of eligible subjects who agreed to participate out of those who were screened
Participant Retention
The proportion of enrolled participants who complete follow-up
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.

Full Information

First Posted
October 11, 2022
Last Updated
October 18, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05579990
Brief Title
Feasibility of Meal Delivery Postpartum
Official Title
Feasibility of a Meal Delivery Intervention for Postpartum Weight Management
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Weight Retention, Obesity
Keywords
Postpartum, Weight management, Meal delivery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
All participants enrolled in the study will receive the meal delivery intervention, so blinding is not possible.
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meal Delivery
Arm Type
Experimental
Arm Description
Meal delivery intervention program designed to help low income postpartum women lose weight through weekly meal delivery and behavioral strategies.
Intervention Type
Behavioral
Intervention Name(s)
Meal Delivery
Intervention Description
10 home-delivered meals per week provided by a local meal delivery company supplemented by remote weekly behavioral support with study staff.
Primary Outcome Measure Information:
Title
Participant Adherence to Intervention
Description
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.
Time Frame
Collected weekly from intervention start (6-21 weeks postpartum) to follow-up (14-29 weeks postpartum)
Secondary Outcome Measure Information:
Title
Study Participation Rate
Description
Percentage of eligible subjects who agreed to participate out of those who were screened
Time Frame
baseline (5-19 weeks postpartum)
Title
Participant Retention
Description
The proportion of enrolled participants who complete follow-up
Time Frame
baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Title
Change in Participant Satisfaction with Diet
Description
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.
Time Frame
baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Other Pre-specified Outcome Measures:
Title
Change in Weight
Description
Body weight measured at baseline and follow-up will be used to calculate weight change.
Time Frame
baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Title
Change in Food Security
Description
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.
Time Frame
baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Title
Change in Perceived Stress
Description
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.
Time Frame
baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Title
Change in Healthy Eating Self-Efficacy
Description
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.
Time Frame
baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Title
Change in Weight Control Self-Efficacy
Description
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.
Time Frame
baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Title
Change in Healthy Eating Index score from baseline to follow-up
Description
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.
Time Frame
three 24-hour dietary recalls on non-consecutive days at baseline (5-19 weeks postpartum) and follow-up (14-29 weeks postpartum)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camille S Worthington, PhD
Phone
205-975-7274
Email
cschneid@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille S Worthington, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille Worthington, PhD
Phone
205-975-7274
Email
cschneid@uab.edu
First Name & Middle Initial & Last Name & Degree
Camille S Worthington, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Feasibility of Meal Delivery Postpartum

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