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Completed

NCT Number: NCT05579990

Feasibility of Meal Delivery Postpartum

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

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Key information

Conditions

Postpartum Weight Retention Body Weight Body Weight Changes Gestational Weight Gain Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 5-45 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

Treatment and study plan

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.

Primary outcomes

  1. Self-Reported Proportion of Received Study Meals Consumed

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

    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.

Secondary outcomes

  1. Study Participation Rate

    Time frame: baseline (5-45 weeks postpartum)

    Total number of eligible subjects who agreed to participate out of those who were screened.

  2. Participant Retention

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

    The number of enrolled participants who completed some or all follow-up assessment visit measurements.

  3. Change in Participant Satisfaction With Diet

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

    To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire (DSAT-28) will be used in which participants respond to 28 statements using a 5-point Likert scale. Responses to all 28-items are averaged to produce a total diet satisfaction score (designed to reflect satisfaction as it relates to following a weight-management diet) ranging from 1-5. Subscale scores for Cost Factor (reflects financial cost of the diet) and Planning & Preparation Factor (reflects amount of time and effort spent in planning and preparing) will also be calculated and range from 1-5. For the overall diet satisfaction score and subscale scores, higher scores represent greater satisfaction. 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.

Other outcomes

  1. Change in Weight

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

    Body weight measured at baseline and follow-up will be used to calculate weight change.

  2. Change in Food Security

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

    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.

  3. Change in Perceived Stress

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

    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.

  4. Change in Healthy Eating Self-Efficacy

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

    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.

  5. Change in Weight Control Self-Efficacy

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

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Feasibility of a Meal Delivery Intervention for Postpartum Weight Management

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 14, 2022
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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