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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD085138-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Henry Ford Health System | OTHER |
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This study, in African American mothers in Detroit, will test an intervention that combines home visiting by experienced peer counselors with a smart phone-based weight control program. The investigators are trying to help mothers breastfeed their babies longer, and also help them get back to the weight they were before they were pregnant. This trial will help the investigators to guide policies in the state of Michigan and has the potential to improve the health of both mothers and babies everywhere.
Excessive pregnancy-related weight retention is an important determinant of obesity and is more common among African American women. At the same time, breastfeeding, which has been recommended as a strategy to decrease weight retention is lowest among African American women. This racial disparity in breastfeeding may partly explain the disparity in obesity, but even if the two are not causally related, a dual intervention designed to increase breastfeeding duration and decrease postpartum weight retention makes practical sense because both are associated with the same critical postpartum time window.
For this study, the investigators will incorporate a postpartum weight management component into an effective breastfeeding support program. This dual intervention will use a combination of in-person, telephone, and interactive web/mobile-based health counseling to provide education and support for breastfeeding difficulties and postpartum weight management. The intervention will be delivered by peer counselors who will be trained to provide support using motivational interviewing techniques with consultation by experts. The investigators have designed the dual intervention to provide encouragement, information, and problem-solving assistance at the appropriate pre or postpartum stage for both breastfeeding support and maternal weight management. The mixed delivery mode has proven effective in other settings and is important to build a trusting relationship while allowing frequent and flexible methods for communicating during this vulnerable time in a new mom's life. The overall goal of this developmental/exploratory R21 proposal is to gather pilot data to effectively refine the intervention so that it can be tested in a larger, longer study using a factorial design in a future R01 phase. The investigators will recruit, in one large inner-city prenatal care clinic (Henry Ford Health System, Detroit, MI), pregnant African American women (32-36 weeks gestation) who are considering breastfeeding (n=80), randomize them to the intervention or to a usual care group, and follow all participants to 20 weeks postpartum. The specific aims are to: 1) test feasibility; 2) assess acceptability; and 3) estimate the effect size of the intervention at 20 weeks postpartum relative to the usual care group on (1) breastfeeding duration and (2) postpartum weight retention. This project is significant because the combined intervention is designed to work synergistically on two interrelated, highly prevalent problems that disproportionately disadvantage African American families.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastfeeding and weight loss support | Experimental | Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management. |
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| Usual care | No Intervention | Participants receive usual care from their prenatal care provider. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breastfeeding and weight loss support | Behavioral | The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Still Breastfeeding at 20 Weeks Postpartum | Count of women who report any breastfeeding at 20 weeks postpartum | 20 weeks postpartum |
| Change in Weight From Baseline | Weight at 20 weeks postpartum minus pre-pregnancy weight. | Baseline and 20 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
Must be pregnant.
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| Name | Affiliation | Role |
|---|---|---|
| Jean M Kerver, PhD | Michigan State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System, New Center One Women's Clinic | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35166571 | Derived | Shipp GM, Weatherspoon LJ, Comstock SS, Norman GS, Alexander GL, Gardiner JC, Kerver JM. Breastfeeding Self-Efficacy as a Predictor of Breastfeeding Intensity Among African American Women in the Mama Bear Feasibility Trial. Breastfeed Med. 2022 May;17(5):453-458. doi: 10.1089/bfm.2021.0301. Epub 2022 Feb 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Breastfeeding and Weight Loss Support | Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management. Breastfeeding and weight loss support: The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss. |
| FG001 | Usual Care | Participants receive usual care from their prenatal care provider. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Breastfeeding and Weight Loss Support | Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management. Breastfeeding and weight loss support: The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss. |
| 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 | Number of Participants Still Breastfeeding at 20 Weeks Postpartum | Count of women who report any breastfeeding at 20 weeks postpartum | Posted | Count of Participants | Participants | 20 weeks postpartum |
|
From study enrollment during late pregnancy through 20 weeks postpartum, or about 6-7 months.
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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 | Breastfeeding and Weight Loss Support | Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management. Breastfeeding and weight loss support: The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean Kerver, PhD, MSc, RD, Assistant Professor | Michigan State University | 231-392-8227 | jkerver@epi.msu.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 | Feb 28, 2018 | Aug 22, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D007774 | Lactation |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |
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| BG001 | Usual Care | Participants receive usual care from their prenatal care provider. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Change in Weight From Baseline | Weight at 20 weeks postpartum minus pre-pregnancy weight. | Posted | Mean | Standard Deviation | pounds | Baseline and 20 weeks postpartum |
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|
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Usual Care | Participants receive usual care from their prenatal care provider. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |