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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD107325 | U.S. NIH Grant/Contract | View source |
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This study is being done to test the feasibility, acceptability, and preliminary efficacy of a meal delivery intervention for managing gestational weight gain among pregnant women with overweight or obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Meal delivery intervention with brief behavioral support. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal Delivery | Behavioral | 10 healthy, home-delivered meals per week + brief weekly remote behavioral support |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in weight from first to last prenatal visit | Weight measured at each prenatal visit will be retrieved from medical records for all participants and used to model total weight change from the first to the last prenatal visit (i.e., gestational weight gain). | First prenatal visit (<15 weeks gestation), last prenatal visit (35+ weeks gestation) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Food Insecurity | 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 (12-15 weeks gestation), (35-36 weeks gestation) |
| Change in Perceived Stress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gareth Dutton, PhD | University of Alabama at Birmingham | Principal Investigator |
| Camille 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 MPIs at gdutton@uabmc.edu or cschneid@uab.edu.
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| D000079262 | Pregnancy in Obesity |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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All participants enrolled will receive the study intervention. A quasi-experimental design will be used to investigate the preliminary efficacy of the meal delivery intervention on gestational weight gain and estimate the effect size of the intervention relative to a non-randomized standard care but weighted control group derived from de-identified hospital records.
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All participants enrolled will receive the study intervention, so blinding is not possible.
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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 (12-15 weeks gestation), (35-36 weeks gestation) |
| Change in Participant Satisfaction with Diet | Determined using the 28-item Diet Satisfaction Questionnaire 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 (12-15 weeks gestation), (35-36 weeks gestation) |
| Proportion of Women Exceeding Institute of Medicine Gestational Weight Gain Guidelines | Weight at the first prenatal visit will be subtracted from weight at the last prenatal visit. Women will be categorized as exceeding 2009 Institute of Medicine gestational weight gain guidelines if the difference is > 11.5 kg gain for women with overweight or >9 kg for women with obesity at the first prenatal visit. | First prenatal visit (<15 weeks gestation), last prenatal visit (35+ weeks gestation) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |