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
Among 250 studies in Breast Feeding with a site in United States — 43 open to participants now, 48 under way, none of them phase 3. Breast Feeding · United States.
Among the 250 studies in Breast Feeding with a site in United States, this one is the 124th largest by enrollment of the 201 interventional ones that give a count, is one of 20 that started in 2017, is one of 163 with no phase, and was the 113th registered.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
Browse Breast Feeding studies →43 of the 250 studies in Breast Feeding with a site in United States are open now. Recruiting first, the newest first:
University of Illinois at Urbana-Champaign · Sites in United States
Eli Lilly and Company · Sites in United States, Canada, Denmark and 4 more countries
University of Alabama at Birmingham · Sites in United States
University of Colorado, Denver · Sites in United States
Loma Linda University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 126 Breast Feeding studies recruiting now, 66 (52%) set no upper age limit and 58 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
250 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 10 · Phase 3 6 · Phase 4 14
First in 2000; this study’s year is marked. 20 started in 2017.
This study's enrollment of 53 is below the median of 100 across 844 interventional studies indexed under Breast Feeding.
Median enrollment 82 across the 201 interventional studies, 88 across the 49 observational. Of the 180 that completed or were terminated, 46 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
22 of 250 have an industry lead sponsor. The 10 most frequent:
Michigan State University is the lead sponsor of 143 studies on the registry; 27 are open to participants now.
Michigan State University has 1 study filed under Breast Feeding — fewer than ten, so there is no comparison to draw.
15 of the studies in Breast Feeding with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07176793University of California, DavisPregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes | 2026-12-30 |
| NCT05457972University Hospitals Cleveland Medical CenterPostpartum Vaginal Estrogen for Breastfeeding Patients | 2026-12-31 |
| NCT06107933Johns Hopkins Bloomberg School of Public HealthDevelopmental Impacts of Microplastics Exposure in Early Life | 2026-12-31 |
| NCT05441709Endeavor HealthFurthering Equity Through Infant Feeding EDucation and Support | 2026-12-31 |
| NCT03838536University of North Carolina, Chapel HillSynergistic Activity of Human Milk Nutrients and Infant Cognition | 2027-03 |
Among the 250 studies in Breast Feeding with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2017 to primary completion in Nov 2018, 20 months.
Results were first posted in Sep 2019, 9 months after primary completion.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 20 months is above that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.