Trial Outcomes & Findings for Feasibility of Meal Delivery Postpartum (NCT NCT05579990)
NCT ID: NCT05579990
Last Updated: 2025-09-23
Results Overview
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.
COMPLETED
NA
11 participants
Collected weekly from intervention start (6-45 weeks postpartum) to follow-up (14-53 weeks postpartum)
2025-09-23
Participant Flow
Not applicable as there was no randomization. All participants began receiving the meal delivery intervention after completing enrollment and baseline assessment measures.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Feasibility of Meal Delivery Postpartum
Baseline characteristics by cohort
| Measure |
Meal Delivery
n=11 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
31.5 years
STANDARD_DEVIATION 4.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
|
Participant Overall Satisfaction with Diet
|
2.95 score on a scale
STANDARD_DEVIATION 0.42 • n=99 Participants
|
|
Diet Satisfaction- Cost Factor
|
2.87 score on a scale
STANDARD_DEVIATION 0.72 • n=99 Participants
|
|
Diet Satisfaction-Planning & Preparation Factor
|
3.44 score on a scale
STANDARD_DEVIATION 0.76 • n=99 Participants
|
|
Body Weight
|
100.3 kilograms
STANDARD_DEVIATION 15.4 • n=99 Participants
|
|
Food Security Score
|
1.5 score on a scale
STANDARD_DEVIATION 2.8 • n=99 Participants
|
|
Perceived Stress
|
12.7 score on a scale
STANDARD_DEVIATION 7.0 • n=99 Participants
|
|
Healthy Eating Self-Efficacy
|
3.8 score on a scale
STANDARD_DEVIATION 0.6 • n=99 Participants
|
|
Weight Control Self-Efficacy
|
3.0 score on a scale
STANDARD_DEVIATION 0.7 • n=99 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Meal Delivery
n=620 Number of Meals Received
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.
|
|---|---|
|
Self-Reported Proportion of Received Study Meals Consumed
Proportion of Meals Participant Ate
|
0.86 Proportion of Received Meals
Standard Deviation 0.25
|
|
Self-Reported Proportion of Received Study Meals Consumed
Proportion of Meals Someone Else in Household Ate
|
0.05 Proportion of Received Meals
Standard Deviation 0.11
|
|
Self-Reported Proportion of Received Study Meals Consumed
Proportion of Meals thrown away/frozen/uneaten
|
0.09 Proportion of Received Meals
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: 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.
Total number of eligible subjects who agreed to participate out of those who were screened.
Outcome measures
| Measure |
Meal Delivery
n=24 Participants
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.
|
|---|---|
|
Study Participation Rate
|
11 Participants
|
SECONDARY outcome
Timeframe: 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.
The number of enrolled participants who completed some or all follow-up assessment visit measurements.
Outcome measures
| Measure |
Meal Delivery
n=11 Participants
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.
|
|---|---|
|
Participant Retention
Completed all follow-up measurements
|
6 Participants
|
|
Participant Retention
Completed some (but not all) follow up measurements
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Meal Delivery
n=6 Participants
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.
|
|---|---|
|
Change in Participant Satisfaction With Diet
Change in overall diet satisfaction score
|
0.17 score on a scale
Standard Deviation 0.5
|
|
Change in Participant Satisfaction With Diet
Change in Cost Factor Score
|
0.3 score on a scale
Standard Deviation 0.8
|
|
Change in Participant Satisfaction With Diet
Change in Planning & Preparation Factor Score
|
-0.2 score on a scale
Standard Deviation 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Body weight measured at baseline and follow-up will be used to calculate weight change.
Outcome measures
| Measure |
Meal Delivery
n=7 Participants
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.
|
|---|---|
|
Change in Weight
|
-0.18 kilograms
Standard Deviation 4.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Meal Delivery
n=6 Participants
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.
|
|---|---|
|
Change in Food Security
|
-0.5 score on a scale
Standard Deviation 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Meal Delivery
n=6 Participants
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.
|
|---|---|
|
Change in Perceived Stress
|
1.8 score on a scale
Standard Deviation 5.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Meal Delivery
n=6 Participants
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.
|
|---|---|
|
Change in Healthy Eating Self-Efficacy
|
-0.6 score on a scale
Standard Deviation 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Meal Delivery
n=6 Participants
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.
|
|---|---|
|
Change in Weight Control Self-Efficacy
|
0.38 score on a scale
Standard Deviation 0.57
|
Adverse Events
Meal Delivery
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Meal Delivery
n=11 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Emesis
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected via weekly electronic surveys sent each week during the 8-week study meal delivery intervention period.
Adverse event data were collected via weekly electronic surveys sent each week during the 8-week study meal delivery intervention period.
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected via weekly electronic surveys sent each week during the 8-week study meal delivery intervention period.
Adverse event data were collected via weekly electronic surveys sent each week during the 8-week study meal delivery intervention period.
|
Additional Information
Dr. Camille Worthington
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place