Feasibility of Meal Delivery Postpartum

Obesity Clinical Trial

Official title:

Feasibility of a Meal Delivery Intervention for Postpartum Weight Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05579990
• Other study ID #: IRB-300010155
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: Camille S Worthington, PhD
• Phone: 205-975-7274
• Email: cschneid[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gestational Weight Gain
• Obesity
• Postpartum Weight Retention

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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	Study Participation Rate	Percentage of eligible subjects who agreed to participate out of those who were screened	baseline (5-19 weeks postpartum)
Secondary	Participant Retention	The proportion of enrolled participants who complete follow-up	baseline (5-19 weeks postpartum), follow-up (14-29 weeks postpartum)
Secondary	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)