Lactational AmenorrheaMEEMANCT03732261
Effects of Exercise and Yogurt on Bone Mineral Density and Immunological Factors in Human Milk: The MEEMA Study
A study testing Exercise and dietary in people with Lactational Amenorrhea and Body Weight Changes, run by North Carolina Agriculture & Technical State University at 1 site in United States.
Trial summary
Obesity in America has risen to epidemic levels over the past 20 years. For women, childbearing itself could be a contributing factor to this high prevalence of excess weight. In addition, for women who breastfeed, lactation is a time of rapid bone loss due to hyperprolactinemia, amenorrhea, and increased bone… Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactational Amenorrhea, Body Weight Changes, Bone Loss
- What is being tested?
- Exercise and dietary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women must be at least 2 weeks postpartum
- be between the ages of 25 to 40
- have a self-reported body mass index (BMI) between 25 and 35 kg/m2
- be fully breastfeeding (< 4 oz of formula given to the infant only on occasion)
- be sedentary for the past 3 months (< 3 weekly sessions of moderate aerobic activity)
- be non-smokers
- had a singleton birth.
Who cannot join
- delivery by cesarean section
- have medical complications where exercise was contraindicated
- have an inability to consume yogurt (i.e. maternal or infant allergies/intolerance to the dairy protein or sugar) or
- a have diagnosis with a disease that affects hormone levels.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina A&T State University
Greensboro, North Carolina, 27411
About this study
Obesity in America has risen to epidemic levels over the past 20 years. For women, childbearing itself could be a contributing factor to this high prevalence of excess weight. In addition, for women who breastfeed, lactation is a time of rapid bone loss due to hyperprolactinemia, amenorrhea, and increased bone turnover, especially in the lumbar spine and hip. The American Academy of Pediatrics recommends exclusive breastfeeding for the first 6 months, continue to at least 12 months with the introduction of complementary foods and up to 2 years. Breastfeeding helps reduce long term maternal weight retention from pregnancy, the risk of childhood obesity and provides a number of immunological factors to promote the immune system and gastrointestinal system of the neonate.
Bone loss due to lactation is usually reversed with weaning; however, not all women recover from this bone loss which increases the risk of osteoporosis later in life. Weight bearing exercise and dairy intake (milk, yogurt, cheese) plus vitamin D supplementation may provide some protection from bone loss. Thus, the objective of this study is to promote long-term lifestyle changes that support healthy lifelong weight management through a community based exercise intervention and daily yogurt consumption program aimed at overweight- to- obese lactating postpartum women.
Read the detailed description
The specific aims of this project are to evaluate in overweight lactating women at 6 and 20 weeks postpartum (PP) whether an exercise and yogurt supplementation intervention, compared to a minimal care group, will:
- Improve body composition. The working hypothesis for this aim, based on previous studies (Lovelady et al 2009; Colleran et al 2012), is thatthe intervention group will have less loss of lean body mass and bone mineral density but more fat loss compared to the minimal care group at 20 weeks PP.
- Promote an increase in cardiovascular fitness. The working hypothesis for this aim, based on previous studies (Lovelady et al 2009; Colleran et al 2012), is that the intervention group will exhibit an increase in predicted maximal oxygen consumption and maximal strength compared to the minimal care group at 20 weeks PP.
- Increase immunological factors within breastmilk. The working hypothesis for this aim, based on a previous study (Lovelady et al 2003), is that the intervention group will exhibit an increase in IgA, lactoferrin, lysozyme and Bidfidus factor concentrations in breast milk which will improve immunological benefits to the nursing infant.
- Conditions
- Lactational Amenorrhea, Body Weight Changes, Bone Loss
- Being tested
- Exercise and dietary
- Keywords
- postpartum, lactation, bone density, exercise, yogurt
- Medical subject headings
- Body Weight Changes, Bone Diseases, Metabolic, Breast Feeding, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and dietaryOther
The 12-week study invention will take place between 6 to 8-weeks postpartum and 18 to 20-weeks postpartum, with a follow-up at one year postpartum. The six-week postpartum time point is to allow for exercise clearance from the participant's obstetrician. The exercise clearance is needed prior to the baseline laboratory measurement. Women will be randomized to an intervention group or minimal care group after all baseline measurements (anthropometrics, cardiovascular fitness test, human milk and blood samples and DXA) at six-weeks postpartum. A random numbers table will be used to stratify by parity and determine groups.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention Group: Women randomized to the intervention group will be given a 3month membership to a community based exercise program, a pedometer and individual dietary recommendations. They will be asked to attend a minimum of three 45 minute to 60 minute exercise sessions per week but no more than five and will gradually build to walk 10,000 steps per day. Childcare and breastfeeding support will be provided. Trained research assistants will lead all group sessions. Weekly workout volume will be calculated and weekly steps will be monitored by research assistants. For the dietary intervention, the women will be provided 6oz of plain yogurt fortified with vitamin D post workout for the 12-week intervention. If any yogurt is out of date (expired), we will dispose of the expired yogurt. Weekly monitoring for the consumption of the yogurt and energy intake will be conducted by face-to-face or telephone interviews by research assistants. Receives: Other: Exercise and dietary |
| Control | No intervention | Minimal Care Group: Women randomized into the minimal care group will be asked not to participate in any structured exercise or make any changes in their diet. They will be permitted to walk their infants in strollers at a leisurely pace (no faster than 2 mph) for no more than 30 minutes per day. After the endpoint measurements of the 12-wk intervention, the minimal care group will be asked to join the community based program provided to the intervention group. The participants will be given the pedometer, individual dietary recommendations and yogurt. Additionally, support by the PI and research assistants for exercise and diet will be provided until the one-year postpartum laboratory measurement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition: Bone Mineral Density
The working hypothesis for this aim, based on previous studies (Lovelady et al 2009; Colleran et al 2012), is that the intervention group will have less loss of lean body mass and bone mineral density but more fat loss compared to the minimal care group at 20 weeks PP.
Measured: 12 weeks
Increase immunological factors within breastmilk
The working hypothesis for this aim, based on a previous study (Lovelady et al 2003), is that the intervention group will exhibit an increase in IgA, lactoferrin, lysozyme and Bidfidus factor concentrations in breast milk which will improve immunological benefits to the nursing infant.
Measured: 12 weeks
Secondary outcomes (1)
Cardiovascular fitness
The working hypothesis for this aim, based on previous studies (Lovelady et al 2009; Colleran et al 2012), is that the intervention group will exhibit an increase in predicted maximal oxygen consumption and maximal strength compared to the minimal care group at 20 weeks PP.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Apr 2019
- Primary completion20 Mar 2020
- Study completion30 Dec 2020
Why it stopped: COVID 19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactational AmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Carolina Agriculture & Technical State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Colleran, North Carolina Agriculture & Technical State University
- Investigators
- Heather L Colleran, PHD, Principal investigator, North Carolina Agriculture & Technical State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732261
- Sponsor's protocol ID
- MEEMA
- Acronym
- MEEMA
- Status last verified
- Mar 2023
- First submitted
- 19 Oct 2018
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise and Yogurt on Bone Mineral Density and Immunological Factors in Human Milk: The MEEMA Study
- ClinicalTrials.gov ID
- NCT03732261
- Acronym / sponsor ID
- MEEMA / MEEMA
- Conditions
- Lactational Amenorrhea, Body Weight Changes, Bone Loss
- Keywords
- postpartum, lactation, bone density, exercise, yogurt
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID 19 pandemic
- Enrolment
- 13 participants (actual)
- Lead sponsor
- North Carolina Agriculture & Technical State UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity in America has risen to epidemic levels over the past 20 years. For women, childbearing itself could be a contributing factor to this high prevalence of excess weight. In addition, for women who breastfeed, lactation is a time of rapid bone loss due to hyperprolactinemia, amenorrhea, and increased bone turnover, especially in the lumbar spine and hip. The American Academy of Pediatrics recommends exclusive breastfeeding for the first 6 months, continue to at least 12 months with the introduction of complementary foods and up to 2 years. Breastfeeding helps reduce long term maternal weight retention from pregnancy, the risk of childhood obesity and provides a number of immunological factors to promote the immune system and gastrointestinal system of the neonate.
Bone loss due to lactation is usually reversed with weaning; however, not all women recover from this bone loss which increases the risk of osteoporosis later in life. Weight bearing exercise and dairy intake (milk, yogurt, cheese) plus vitamin D supplementation may provide some protection from bone loss. Thus, the objective of this study is to promote long-term lifestyle changes that support healthy lifelong weight management through a community based exercise intervention and daily yogurt consumption program aimed at overweight- to- obese lactating postpartum women.
Detailed description
The specific aims of this project are to evaluate in overweight lactating women at 6 and 20 weeks postpartum (PP) whether an exercise and yogurt supplementation intervention, compared to a minimal care group, will:
- Improve body composition. The working hypothesis for this aim, based on previous studies (Lovelady et al 2009; Colleran et al 2012), is thatthe intervention group will have less loss of lean body mass and bone mineral density but more fat loss compared to the minimal care group at 20 weeks PP.
- Promote an increase in cardiovascular fitness. The working hypothesis for this aim, based on previous studies (Lovelady et al 2009; Colleran et al 2012), is that the intervention group will exhibit an increase in predicted maximal oxygen consumption and maximal strength compared to the minimal care group at 20 weeks PP.
- Increase immunological factors within breastmilk. The working hypothesis for this aim, based on a previous study (Lovelady et al 2003), is that the intervention group will exhibit an increase in IgA, lactoferrin, lysozyme and Bidfidus factor concentrations in breast milk which will improve immunological benefits to the nursing infant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Exercise and dietaryIntervention Group: Women randomized to the intervention group will be given a 3month membership to a community based exercise program, a pedometer and individual dietary recommendations. They will be asked to attend a minimum of three 45 minute to 60 minute exercise sessions per week but no more than five and will gradually build to walk 10,000 steps per day. Childcare and breastfeeding support will be provided. Trained research assistants will lead all group sessions. Weekly workout volume will be calculated and weekly steps will be monitored by research assistants. For the dietary intervention, the women will be provided 6oz of plain yogurt fortified with vitamin D post workout for the 12-week intervention. If any yogurt is out of date (expired), we will dispose of the expired yogurt. Weekly monitoring for the consumption of the yogurt and energy intake will be conducted by face-to-face or telephone interviews by research assistants. |
| Control | No intervention | –Minimal Care Group: Women randomized into the minimal care group will be asked not to participate in any structured exercise or make any changes in their diet. They will be permitted to walk their infants in strollers at a leisurely pace (no faster than 2 mph) for no more than 30 minutes per day. After the endpoint measurements of the 12-wk intervention, the minimal care group will be asked to join the community based program provided to the intervention group. The participants will be given the pedometer, individual dietary recommendations and yogurt. Additionally, support by the PI and research assistants for exercise and diet will be provided until the one-year postpartum laboratory measurement. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- women must be at least 2 weeks postpartum
- be between the ages of 25 to 40
- have a self-reported body mass index (BMI) between 25 and 35 kg/m2
- be fully breastfeeding (< 4 oz of formula given to the infant only on occasion)
- be sedentary for the past 3 months (< 3 weekly sessions of moderate aerobic activity)
Key exclusion criteria (4 listed)
- delivery by cesarean section
- have medical complications where exercise was contraindicated
- have an inability to consume yogurt (i.e. maternal or infant allergies/intolerance to the dairy protein or sugar) or
- a have diagnosis with a disease that affects hormone levels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and dietaryThe 12-week study invention will take place between 6 to 8-weeks postpartum and 18 to 20-weeks postpartum, with a follow-up at one year postpartum. The six-week postpartum time point is to allow for exercise clearance from the participant's obstetrician. The exercise clearance is needed prior to the baseline laboratory measurement. Women will be randomized to an intervention group or minimal care group after all baseline measurements (anthropometrics, cardiovascular fitness test, human milk and blood samples and DXA) at six-weeks postpartum. A random numbers table will be used to stratify by parity and determine groups. | Other | Intervention |
Primary outcome
Body composition: Bone Mineral Density
Time frame: 12 weeks
The working hypothesis for this aim, based on previous studies (Lovelady et al 2009; Colleran et al 2012), is that the intervention group will have less loss of lean body mass and bone mineral density but more fat loss compared to the minimal care group at 20 weeks PP.
Increase immunological factors within breastmilk
Time frame: 12 weeks
The working hypothesis for this aim, based on a previous study (Lovelady et al 2003), is that the intervention group will exhibit an increase in IgA, lactoferrin, lysozyme and Bidfidus factor concentrations in breast milk which will improve immunological benefits to the nursing infant.
1 secondary outcome
Cardiovascular fitness
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: COVID 19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather L Colleran, PHD principal investigator
North Carolina Agriculture & Technical State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and dietary in people with Lactational Amenorrhea and Body Weight Changes, run by North Carolina Agriculture & Technical State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID 19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition: Bone Mineral Density (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.