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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD000502 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This study is being done to assess the feasibility and acceptability of a meal delivery intervention among low-income postpartum women with obesity.
This is a single-group pilot study in which subjects will receive 10 home-delivered meals per week for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal Delivery | Experimental | Meal delivery intervention program designed to help low income postpartum women lose weight through weekly meal delivery and behavioral strategies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Collected weekly from intervention start (6-45 weeks postpartum) to follow-up (14-53 weeks postpartum) |
| Measure | Description | Time Frame |
|---|---|---|
| Study Participation Rate | Total number of eligible subjects who agreed to participate out of those who were screened. | baseline (5-45 weeks postpartum) |
| Participant Retention | The number of enrolled participants who completed some or all follow-up assessment visit measurements. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Body weight measured at baseline and follow-up will be used to calculate weight change. | baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
| Change in Food Security |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Camille S Worthington, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
De-identified individual participant data (IPD) that underlie the results reported in a publication will be made available upon request beginning 9 months and ending 36 months following article publication. The research team will keep a record of all individuals and/or research teams who request and receive a copy of the project data. Interested investigators will be asked to submit a document indicating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed.
Data requests can be submitted starting 9 months after publication of results and ending 36 months following article publication.
Access to IPD stripped of all HIPAA identifiers (except age) for this study can be requested by qualified researchers engaging in independent scientific research whose proposed research has received Institutional Review Board approval, and will be provided following review and approval of a research proposal and timeline, statistical analysis plan, and goals (e.g., manuscripts, presentations, grant applications). The Principal Investigator (PI) and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed. Based on institutional policies, execution of a Data Sharing Agreement may be required prior to sharing of IPD. IPD requests can be made to the PI at cschneid@uab.edu.
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Not applicable as there was no randomization. All participants began receiving the meal delivery intervention after completing enrollment and baseline assessment measures.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Proportion of Received Meals | Collected weekly from intervention start (6-45 weeks postpartum) to follow-up (14-53 weeks postpartum) | Number of Meals Received | Number of Meals Received |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emesis | Gastrointestinal disorders | Systematic Assessment | There was a single instance of a participant reporting one episode of emesis once during the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Camille Worthington | University of Alabama at Birmingham | 205-975-7274 | cschneid@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 10, 2025 | Jun 20, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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All participants enrolled in the study will receive the meal delivery intervention, so blinding is not possible.
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| baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
| 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. | 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.
| baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
| 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 (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
| 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 (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
| 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 (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participant Overall Satisfaction with Diet | To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire (DSAT-28) was used in which participants respond to 28 statements using a 5-point Likert scale. Responses are averaged to produce an overall total diet satisfaction score ranging from 1-5. Higher scores represent greater satisfaction. The overall diet satisfaction score is designed to reflect satisfaction as it relates to following a weight-management diet. | Mean | Standard Deviation | score on a scale |
|
| Diet Satisfaction- Cost Factor | To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire was used in which participants respond to 28 statements using a 5-point Likert scale. Responses to 5-items related specifically to cost of the diet are averaged to produce a Cost Factor score ranging from 1-5. Higher scores represent greater satisfaction. The Cost Factor subscale score reflects financial cost of the diet. | Mean | Standard Deviation | score on a scale |
|
| Diet Satisfaction-Planning & Preparation Factor | To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire was used in which participants respond to 28 statements using a 5-point Likert scale. Responses to 5-items related specifically to meal planning and preparation are averaged to produce a Planning & Preparation Factor score ranging from 1-5. Higher scores represent greater satisfaction. The Planning & Preparation Factor score reflects the amount of time and effort spent in planning and preparing the diet. | Mean | Standard Deviation | score on a scale |
|
| Body Weight | Body weight in kilograms measured at the baseline assessment. | Mean | Standard Deviation | kilograms |
|
| Food Security Score | 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| Healthy Eating Self-Efficacy | Participants were 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. | Mean | Standard Deviation | score on a scale |
|
| Weight Control Self-Efficacy | Participants were 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. | Mean | Standard Deviation | score on a scale |
|
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.
|
|
| Secondary | Study Participation Rate | Total number of eligible subjects who agreed to participate out of those who were screened. | 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. | Posted | Count of Participants | Participants | baseline (5-45 weeks postpartum) |
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| Secondary | Participant Retention | The number of enrolled participants who completed some or all follow-up assessment visit measurements. | 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. | Posted | Count of Participants | Participants | baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
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| Other Pre-specified | Change in Weight | Body weight measured at baseline and follow-up will be used to calculate weight change. | Change calculated as weight at 8-week follow up minus weight at baseline, with negative values indicating weight loss from baseline to follow up. | Posted | Mean | Standard Deviation | kilograms | baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
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|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum) |
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| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment | There was a single instance of a participant reporting having diarrhea once during the intervention. |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
|