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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05579990
Other study ID # IRB-300010155
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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