An interventional study of Breastfeeding and weight loss support in Breastfeeding and Weight Loss, sponsored by Michigan State University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-11.
Sponsored by Michigan State University · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.
Behavioral: Breastfeeding and weight loss support
Participants receive usual care from their prenatal care provider.
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.
Number of Participants Still Breastfeeding at 20 Weeks Postpartum
Count of women who report any breastfeeding at 20 weeks postpartum
Time frame: 20 weeks postpartum
Change in Weight From Baseline
Weight at 20 weeks postpartum minus pre-pregnancy weight.
Time frame: Baseline and 20 weeks postpartum
| Milestone | Breastfeeding and Weight Loss Support | Usual Care |
|---|---|---|
| Started | 28 | 25 |
| Completed | 18 | 17 |
| Not completed | 10 | 8 |
Count of women who report any breastfeeding at 20 weeks postpartum
| Participants | Breastfeeding and Weight Loss Support | Usual Care |
|---|---|---|
| Number of Participants Still Breastfeeding at 20 Weeks Postpartum | 9 | 8 |
Weight at 20 weeks postpartum minus pre-pregnancy weight.
| pounds | Breastfeeding and Weight Loss Support | Usual Care |
|---|---|---|
| Change in Weight From Baseline | 1.5 ± 19.2 | 11.7 ± 22.3 |
Collected over From study enrollment during late pregnancy through 20 weeks postpartum, or about 6-7 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Breastfeeding and Weight Loss Support | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Usual Care | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | Breastfeeding and Weight Loss Support | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 28 | 25 | 53 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Breastfeeding and Weight Loss Support | Usual Care | Total |
|---|---|---|---|
| Female | 28 | 25 | 53 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Breastfeeding and Weight Loss Support | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 28 | 25 | 53 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Breastfeeding and Weight Loss Support | Usual Care | Total |
|---|---|---|---|
| United States | 28 | 25 | 53 |
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Michigan State University