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Feasibility of Meal Delivery Postpartum

Feasibility of a Meal Delivery Intervention for Postpartum Weight Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05579990
Enrollment
11
Registered
2022-10-14
Start date
2023-09-27
Completion date
2025-09-11
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Postpartum Weight Retention

Keywords

Postpartum, Weight management, Meal delivery

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.

Interventions

BEHAVIORALMeal Delivery

10 home-delivered meals per week provided by a local meal delivery company supplemented by remote weekly behavioral support with study staff.

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Masking description

All participants enrolled in the study will receive the meal delivery intervention, so blinding is not possible.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self-Reported Proportion of Received Study Meals ConsumedCollected 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

MeasureTime frameDescription
Study Participation Ratebaseline (5-45 weeks postpartum)Total number of eligible subjects who agreed to participate out of those who were screened.
Participant Retentionbaseline (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.
Change in Participant Satisfaction With Dietbaseline (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

MeasureTime frameDescription
Change in Weightbaseline (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.
Change in Weight Control Self-Efficacybaseline (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.
Change in Food Securitybaseline (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.
Change in Perceived Stressbaseline (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.
Change in Healthy Eating Self-Efficacybaseline (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.

Countries

United States

Participant flow

Pre-assignment details

Not applicable as there was no randomization. All participants began receiving the meal delivery intervention after completing enrollment and baseline assessment measures.

Participants by arm

ArmCount
Meal Delivery
Meal delivery intervention program designed to help low-income postpartum women lose weight through weekly meal delivery and behavioral strategies. Meal Delivery: 10 home-delivered meals per week for 8 weeks provided by a local meal delivery company supplemented by remote weekly behavioral support with study staff.
11
Total11

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up3

Baseline characteristics

CharacteristicMeal Delivery
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
Age, Continuous31.5 years
STANDARD_DEVIATION 4.7
Body Weight100.3 kilograms
STANDARD_DEVIATION 15.4
Diet Satisfaction- Cost Factor2.87 score on a scale
STANDARD_DEVIATION 0.72
Diet Satisfaction-Planning & Preparation Factor3.44 score on a scale
STANDARD_DEVIATION 0.76
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Food Security Score1.5 score on a scale
STANDARD_DEVIATION 2.8
Healthy Eating Self-Efficacy3.8 score on a scale
STANDARD_DEVIATION 0.6
Participant Overall Satisfaction with Diet2.95 score on a scale
STANDARD_DEVIATION 0.42
Perceived Stress12.7 score on a scale
STANDARD_DEVIATION 7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
8 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
3 Participants
Region of Enrollment
United States
11 participants
Sex: Female, Male
Female
11 Participants
Sex: Female, Male
Male
0 Participants
Weight Control Self-Efficacy3.0 score on a scale
STANDARD_DEVIATION 0.7

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 11
other
Total, other adverse events
1 / 11
serious
Total, serious adverse events
0 / 11

Outcome results

Primary

Self-Reported Proportion of Received Study Meals Consumed

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.

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

Population: The total number of meals received were analyzed to determine the average proportion of provided study meals the participant reportd they ate, others in the household ate, and that were thrown away/frozen/uneaten per week. One participant did not receive meals for 2 weeks due to delivery errors, which is why the total units analyzed is 620.

ArmMeasureGroupValue (MEAN)Dispersion
Meal DeliverySelf-Reported Proportion of Received Study Meals ConsumedProportion of Meals Participant Ate0.86 Proportion of Received MealsStandard Deviation 0.25
Meal DeliverySelf-Reported Proportion of Received Study Meals ConsumedProportion of Meals Someone Else in Household Ate0.05 Proportion of Received MealsStandard Deviation 0.11
Meal DeliverySelf-Reported Proportion of Received Study Meals ConsumedProportion of Meals thrown away/frozen/uneaten0.09 Proportion of Received MealsStandard Deviation 0.24
Secondary

Change in Participant Satisfaction With Diet

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.

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

Population: Change calculated as score at 8-week follow up minus score at baseline, with positive values indicating an increase in score (which reflects an increase in satisfaction) from baseline to follow up.

ArmMeasureGroupValue (MEAN)Dispersion
Meal DeliveryChange in Participant Satisfaction With DietChange in overall diet satisfaction score0.17 score on a scaleStandard Deviation 0.5
Meal DeliveryChange in Participant Satisfaction With DietChange in Cost Factor Score0.3 score on a scaleStandard Deviation 0.8
Meal DeliveryChange in Participant Satisfaction With DietChange in Planning & Preparation Factor Score-0.2 score on a scaleStandard Deviation 0.9
Secondary

Participant Retention

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

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

Population: The overall number of participants analyzed (N=11) reflects the number of participants who enrolled in the study, including those who completed all of the 8-week follow-up assessment measurements, those who completed some (but not all) of the 8-week follow-up assessment measurements, and those that did not complete any of the 8-week follow-up assessment.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Meal DeliveryParticipant RetentionCompleted all follow-up measurements6 Participants
Meal DeliveryParticipant RetentionCompleted some (but not all) follow up measurements2 Participants
Secondary

Study Participation Rate

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

Time frame: baseline (5-45 weeks postpartum)

Population: The overall Number of Participants Analyzed (N=24) reflects the total number of participants who were screened, including those who may not have been eligible/consented into the study.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Meal DeliveryStudy Participation Rate11 Participants
Other Pre-specified

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.

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

Population: Change calculated as food security score at 8-week follow up minus score at baseline, with negative values indicating an increase in food security from baseline to follow up.

ArmMeasureValue (MEAN)Dispersion
Meal DeliveryChange in Food Security-0.5 score on a scaleStandard Deviation 0.8
Other Pre-specified

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.

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

Population: Change calculated as score at 8-week follow up minus score at baseline, with positive values indicating an increase in self-efficacy from baseline to follow up.

ArmMeasureValue (MEAN)Dispersion
Meal DeliveryChange in Healthy Eating Self-Efficacy-0.6 score on a scaleStandard Deviation 0.9
Other Pre-specified

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.

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

Population: Change calculated as score at 8-week follow up minus score at baseline, with positive values indicating an increase in perceive stress score from baseline to follow up.

ArmMeasureValue (MEAN)Dispersion
Meal DeliveryChange in Perceived Stress1.8 score on a scaleStandard Deviation 5.9
Other Pre-specified

Change in Weight

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

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

Population: Change calculated as weight at 8-week follow up minus weight at baseline, with negative values indicating weight loss from baseline to follow up.

ArmMeasureValue (MEAN)Dispersion
Meal DeliveryChange in Weight-0.18 kilogramsStandard Deviation 4.77
Other Pre-specified

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.

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

Population: Change calculated as score at 8-week follow up minus score at baseline, with positive values indicating an increase in self-efficacy from baseline to follow up.

ArmMeasureValue (MEAN)Dispersion
Meal DeliveryChange in Weight Control Self-Efficacy0.38 score on a scaleStandard Deviation 0.57

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026