Breastfeeding Support and Weight Management for Black Women: A Dual Intervention
Phase: NA
Conditions: Breastfeeding, Weight Loss
Sponsor: Michigan State University

COVER PAGE 
 
Official Title of the Study: Breastfeeding Support and Weight Management for Black 
Women: A Dual Intervention 
 
ClinicalTrials.gov ID: NCT03480048 
Date (of most recent IRB approval for document contents): Feb 28, 2018 

Page 1 of 6 
 
 
 
 
 
 
 
 
CONSENT TO 
PARTICIPATE IN A 
RESEARCH STUDY 
(HFH IRB form rev: 02/2012) 
DATE: 
MRN: 
NAME: 
 
 
PROJECT TITLE: 
Mothers Allied with Mothers Around Breastfeeding Encouragement And 
Renewed Health (Mama Bear) 
 
Gwen Alexander, Ph.D. 
Research Scientist 
Henry Ford Health System 
Public Health Sciences 
1 Ford Place, 5C 
Detroit MI 48202 
 
1. WHY IS THIS RESEARCH BEING DONE? 
 
The purposes of this study are to 1) learn what kinds of support will help women meet their goals for 
breastfeeding and weight management after their baby is born and 2) to test mom’s urine and blood for 
nutrition factors that may help us understand how breastfeeding and weight loss after a baby is born affects 
the health of mothers and their baby.  You are being asked to take part in this research study because you 
are an African American woman in the later months of your pregnancy and you said you were interested in 
breastfeeding your baby. We will enroll about 80 women in this research study at Henry Ford Health  
System (HFHS). This study is funded by the National Institutes of Health (NIH R21) and is a group project 
between HFHS and Michigan State University (MSU). 
 
2. WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY? 
 
There will be two groups in the study. The group you are assigned to will be chosen by chance (like 
flipping a coin).  Both groups will get educational information about how to get a healthy start for both mom 
and baby.  One group will get written information, and the other group will get information from an online 
program and will have in-person visits from a community health worker. 
 
Women in both groups will be asked to: 
1) Answer survey questions three (3) times during the 6-month study.  Have your height, weight and 
body composition measured three (3) times during the 6-month study.  Body composition will be 
measured with a bioelectrical impedance analysis (BIA) scale that sends a small current through 
your body that you can’t feel. This information will be collected from you either at the NCO clinic or 
at your home. 
2) Have some urine (from the sample you give your doctor during your visit) collected two (2) times 
during the 6-month study (today and at your routine doctor visit that will be about 6 weeks after your 
baby is born). Your urine will be tested for iodine and some environmental chemicals that interfere 
with iodine uptake into the thyroid gland (including perchlorate which is found in many products and 
thiocyanate which is found in cigarette smoke and some foods). 
APPROVAL PERIOD 
 
Feb 28, 2018 – Feb 27, 2019 
 
 
INSTITUTIONAL REVIEW BOARD 

Page 2 of 6 
 
 
 
 
 
 
 
 
CONSENT TO 
PARTICIPATE IN A 
RESEARCH STUDY 
(HFH IRB form rev: 02/2012) 
DATE: 
MRN: 
NAME: 
 
 
PROJECT TITLE: 
Mothers Allied with Mothers Around Breastfeeding Encouragement And 
Renewed Health (Mama Bear) 
3) Have some extra blood (2-4 teaspoons or 10-20 ml) collected and stored two (2) times during the 6- 
month study (today and at your routine doctor visit that will be about 6 weeks after your baby is 
born). Your blood will be tested for nutrition factors (including ferritin which measures your iron 
status and carotenoid concentrations which estimates your fruit and vegetable intake), and other 
factors (including thyroid hormone). 
4) Allow your medical records from pregnancy, labor and delivery and your baby’s medical records to 
be reviewed by the research team. 
5) Researchers will collect health and other information concerning the birth of your child as reported 
to the Michigan Department of Health and Human Services (MDHHS) at the time of your child’s 
birth. In order to locate your baby’s birth certificate, research staff will request your social security 
number. 
All of the procedures at these data collection visits are extra – these are things that you will not do if you 
choose not to participate in the study.  None of these data collection procedures are experimental. If your 
identifiable specimens or health information are selected for use in additional research, you will be 
contacted for permission. 
 
All women: 
At visit 1, which will be today, if you choose to participate, you will have the following procedures: we 
will measure your height, weight and body composition, and ask you if we can collect some urine and 
blood.  If you choose not to participate in this collection, you may still enroll. 
At visit 2, which will be by telephone, a researcher will call you—within the next week or two— and ask 
you some survey questions about your social situation, your diet and physical activity habits (about 25 
minutes to complete). 
At visits 3 and 4, after your baby is born, we will meet you at NCO or at your home to measure your 
weight and ask you the same survey questions and a few more about what you are feeding your baby 
(about 25 minutes to complete). 
 
Visit 3 will be when your baby is about 4-8 weeks old. 
 
Visit 4 will be when your baby is about 20 weeks (5 months old). 
 
We will try to schedule these study visits at the same time you come to see your doctor or your baby’s 
doctor, but if that doesn’t work, we will ask your permission to schedule a visit at your home. 
 
For women in the group that gets information from the online program:  You will receive information and be 
encouraged to use an online program to record activities related to returning to your pre-baby weight.  You 
will also have one-on-one visits, at your home and by telephone, with a community health worker to talk 
about infant feeding and your weight before and after the baby is born. These visits are extra beyond your 
APPROVAL PERIOD 
 
Feb 28, 2018 – Feb 27, 2019 
 
 
INSTITUTIONAL REVIEW BOARD 

Page 3 of 6 
 
 
 
 
 
 
 
 
CONSENT TO 
PARTICIPATE IN A 
RESEARCH STUDY 
(HFH IRB form rev: 02/2012) 
DATE: 
MRN: 
NAME: 
 
 
PROJECT TITLE: 
Mothers Allied with Mothers Around Breastfeeding Encouragement And 
Renewed Health (Mama Bear) 
regular prenatal care at HFHS and after your baby is born. 
The visits by the community health worker 
and the use of the online program are new ways to offer support to pregnant women and new moms. We 
are testing these ways of communicating with women to understand how best to support women like you 
after a new baby is born. 
 
 
3. WHAT ARE THE RISKS OF THE STUDY? 
We do not expect any increase in physical, psychological, social, legal nor economic risks to you or your 
baby from being in this study.  You should tell the person obtaining your consent about any other medical 
research studies you are involved in right now.  It is not expected that you will have any complications or 
discomforts from being in this study. There may be risks or discomforts that are not known at this time. 
 
4. WHAT ARE THE BENEFITS TO TAKING PART IN THE STUDY? 
The potential benefits to you for taking part in this study include all of the many health and emotional 
benefits associated with either breastfeeding or weight management or both.  You may also benefit from 
the feeling of being involved in an important study that may help improve two important health activities 
among African American women – breastfeeding and postpartum weight management. 
 
5. WHAT OTHER OPTIONS ARE THERE? 
Your participation in this study is completely voluntary. 
You have the right to refuse to be in the study or 
to stop at any time without affecting your present or future medical care. At this time, there is no known 
other study like this one. If you wish, you may talk to your doctor about your other choices before you 
decide if you will take part in this study. 
 
6. WHAT ABOUT CONFIDENTIALITY? 
 
By signing this consent form, you agree that we may collect, use and release your personal and health 
information for the purpose of this research study. 
 
We on our study team may collect and use: 
 
Your existing medical records. 
 
New health information about you and your baby created during this study. 
 
Health insurance and other billing information. 
 
We (HFHS) may release this information, using your study identification without names attached, to the 
following people: 
APPROVAL PERIOD 
 
Feb 28, 2018 – Feb 27, 2019 
 
 
INSTITUTIONAL REVIEW BOARD 

 
 
 
 
 
 
 
CONSENT TO 
PARTICIPATE IN A 
RESEARCH STUDY 
(HFH IRB form rev: 02/2012) 
DATE: 
MRN: 
NAME: 
 
 
PROJECT TITLE: 
Mothers Allied with Mothers Around Breastfeeding Encouragement And 
Renewed Health (Mama Bear) 
 
The Principal Investigator and his/her associates who work on, or oversee the research activities. 
 
Government officials who oversee research. 
 
The research sponsor National Institutes of Health. 
 
Your insurance company or others responsible for paying your medical bills. 
 
Other researchers at other institutions participating in the research. 
 
The Michigan State University Human Research Protection Program. 
 
Once your de-identified information (no name attached) has been released according to this consent form, 
it could be released again and may no longer be protected by federal privacy regulations. 
 
This consent form, test results, medical reports and other information about you from this study may be 
placed into your medical record. Generally, you are allowed to look at your medical record.  During the 
research study, you will not be allowed to look at your research study information that is not in your medical 
record. 
 
HFHS or others in this research group may publish the results of this study.  No names, identifying pictures 
or other direct identifiers will be used in any public presentation or publication about this study unless you 
sign a separate consent allowing that use. 
 
This consent to use and release your personal and health information will not expire at the end of this 
research study. The research records will be maintained for a minimum of 3 years after the end of the 
study. 
 
You do not have to sign this consent to release your medical information and may cancel it at any time. If 
you decide not to sign this consent or cancel your consent, you cannot participate in this study. If you notify 
us that you wish to stop participating in this study, we may continue to use and release the information that 
has already been collected. 
 
If you would like to talk about this study or withdraw for any reason, you may contact the principal 
investigator, Gwen Alexander, Ph.D., at (313) 874-6737 or the HFHS IRB Coordinator (313) 916-2024 to 
cancel your consent and we will send you a form to sign or you can send a written and dated notice to the 
principal investigator at the address listed on the first page of this form. 
 
7. WHAT IF I AM INJURED? 
There is no federal, state, or other program that will compensate you or pay for your medical care if you are 
injured as a result of participating in this study.  You and/or your medical insurance may have to pay for 
Page 4 of 6 
APPROVAL PERIOD 
 
Feb 28, 2018 – Feb 27, 2019 
 
 
INSTITUTIONAL REVIEW BOARD 

Page 5 of 6 
 
 
 
 
 
 
 
 
CONSENT TO 
PARTICIPATE IN A 
RESEARCH STUDY 
(HFH IRB form rev: 02/2012) 
DATE: 
MRN: 
NAME: 
 
 
PROJECT TITLE: 
Mothers Allied with Mothers Around Breastfeeding Encouragement And 
Renewed Health (Mama Bear) 
your medical care if you are injured as a result of participating in this study.  You are not giving up any of 
your legal rights by signing this consent form. 
 
8. WHO DO I CALL WITH QUESTIONS ABOUT THE STUDY OR TO REPORT AN INJURY? 
 
Gwen Alexander, Ph.D., or her staff member has explained this research study and has offered to answer 
any questions.  If you have questions about the study procedures, or to report an injury you may contact 
Gwen Alexander at (313) 874-6737. There is no federal, state or other program that will compensate you 
or pay for your medical care if you are injured as a result of participating in this study.  Youi and/or your 
medical insurance may have to pay for your medical care if you are injured as a result of participating in 
this study.  You are not giving up any of your legal rights by signing this consent form. 
 
If you have questions about your rights as a research subject, you may contact the Henry Ford Health 
System IRB Coordinator at (313) 916-2024. The IRB (Institutional Review Board) is a group of people at 
HFHS who review all of the research to protect your rights. 
 
9. DO I HAVE TO PARTICIPATE IN THIS STUDY? 
 
No, your participation in this research study is voluntary.  If you decide to participate, you can stop at any 
time. If this happens, you may be asked to return for a visit for safety reasons.  You will get the same 
medical care from HFHS whether or not you participate in this study. There will be no penalties or loss of 
benefits to which you would otherwise be entitled if you choose not to participate or if you choose to stop 
your participation once you have started. You will be told about any significant information that is 
discovered that could reasonably affect your willingness to continue being in the study. 
 
10. WHO ELSE CAN STOP MY PARTICIPATION? 
 
While this is not anticipated due to the nature of this study, the Principal Investigator can end your 
participation in the research study at any time. The Principal Investigator, sponsor or your doctor can end 
your participation in the research study at any time.  If this happens, you may be asked to return for a visit 
for safety reasons. 
 
11. WILL IT COST ANYTHING TO PARTICIPATE? 
 
We do not expect there to be any additional costs to you if you participate in this study. Items related to the 
routine medical care that you would receive even if you did not participate in this study will be billed to you 
or your insurance company. You have the right to ask what it will cost you to take part in this study. 
APPROVAL PERIOD 
 
Feb 28, 2018 – Feb 27, 2019 
 
 
INSTITUTIONAL REVIEW BOARD 

Page 6 of 6 
 
 
 
 
 
 
 
 
CONSENT TO 
PARTICIPATE IN A 
RESEARCH STUDY 
(HFH IRB form rev: 02/2012) 
DATE: 
MRN: 
NAME: 
 
 
PROJECT TITLE: 
Mothers Allied with Mothers Around Breastfeeding Encouragement And 
Renewed Health (Mama Bear) 
12. WILL I BE PAID TO PARTICIPATE? 
If you consent to participate and data collection begins, you will be given gift cards at four different times 
during the study to thank you for participating. You will receive: 
 
$20 gift card today 
 
$30 gift card after your phone interview that will be within a few weeks after today’s visit 
 
$50 gift card after the study visit when your baby is about six weeks old and 
 
$50 gift card after completion of the final survey when your baby is about five months old. 
We will also provide you with some non-monetary gifts (like a teddy bear).  If you complete the study, you 
will receive a total of $150 to thank you. If you do not finish the study, you will be given the gift cards for the 
parts of the study that you did complete. 
13. CONSENT 
You have read this consent form or it has been read and explained to you.  You understand what you are 
being asked to do.  Your questions have been answered.  Any technical terms you did not understand have 
been explained to you. You agree to be in this study.  You will be given a copy of this consent form. 
 
 
Signature of Subject 
Date 
Time 
 
 
Print Name of Subject 
 
 
Witness to Signature 
Date 
Time 
 
 
Print Name of Person Obtaining Consent 
 
 
Signature of Person Obtaining Consent 
Date 
Time 
APPROVAL PERIOD 
 
Feb 28, 2018 – Feb 27, 2019 
 
 
INSTITUTIONAL REVIEW BOARD 

Analysis Plan: 
 
Aim 1: Feasibility of recruitment and retention: Feasibility will be assessed at multiple points:  
enrollment rate (percent of eligible and approached women); percent of participants for whom 
study staff is notified of hospital admission for birth; percent of participants completing each 
additional data collection point. By compartmentalizing our feasibility assessment in this R21 
exploratory/developmental project, we will be better able to target specific areas for refinement 
to inform our planned phase III trial. Retention will be assessed by the percent of participants 
who complete the 20 week postpartum data collection visit. 
 
Aim 2: Acceptability will be measured at each data collection point using a brief questionnaire 
developed by the research team that will allow participants to rate the value and utility of the 
intervention content and give their opinions about the format, ease of use, and delivery method. 
Control group participants will be asked a similar set of questions to compare satisfaction with 
usual care practices. Engagement will be assessed as percent of intervention arm participants 
completing each planned intervention contact and by the frequency of log-ins to the online 
system, use of web/mobile-based tracking tools, and interactions with peer counselors. 
Feasibility and acceptability will be assessed separately from, but also in relation to the primary 
outcomes of breastfeeding duration and weight retention. For example, we will assess the 
number of women who discontinue BFing but continue tracking diet and exercise. These results 
will guide our structured interview questions planned for the final data collection visit (20 wks 
postpartum). 
 
Aim 3: Estimate the preliminary effect size of the intervention relative to a) the control group (at 
20 weeks postpartum) and secondarily to b) patients in the same health system who are not 
enrolled in our study (via electronic medical records at 6 weeks postpartum) on: (1) 
breastfeeding duration, and (2) postpartum weight retention. Statistical Analyses: Subjects will 
be randomized to treatment (TRT) or control (CNT). Adequacy of the randomization: 
Randomization adequacy will be tested by comparing relevant baseline maternal and infant 
characteristics between the two study arms. Where substantive differences exist, they will 
be controlled for in subsequent analyses. We will test the degree of similarity, however, 
following Altman we will be guided by the degree of dissimilarity, not strict statistical significance. 
Outcomes and Analysis: The data on n participants are denoted by with outcome and 
explanatory variables in the i-th participant. The two main outcomes are: (1) Duration of 
breastfeeding assessed by number of days postpartum at infant weaning (possible range=0-140 
d), and (2) Weight retention assessed by the ratio of the maternal weight at 20 weeks 
postpartum to the pre-pregnancy weight. Both outcomes are regarded as continuous and will be 
analyzed using linear models. If data are found to be skewed, a logarithmic or square-root 
transformation g will be applied to . To assess the effect of treatment on outcome we will fit the 
model and test the hypothesis where is the coefficient for the TRT group indicator, with CNT as 
referent. Results will be presented as (1) a point estimate and 95% confidence interval for , with 
and without regression-adjustment and (2) a standard two-sample t-test of 0 H . 
Statistical Power: With a total sample size of 80 women randomized to TNT, CNT we can detect 
at least a moderate effect size of 0.65 (i.e., in units of standard deviation) with power of 80% (2-
sided test, alpha=0.05). Our objective, however, is the estimation of effect size rather than 
testing for significance.