OsteoporosisBEHIPNCT00966381
Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!
A study testing Exercise and weight loss intervention in people with Osteoporosis and Obesity, run by University of North Carolina, Greensboro at 1 site in United States.
Trial summary
Approximately 8 million American women suffer from osteoporosis, and one out of every two women over the age of 50 will have an osteoporotic-related fracture in their lifetime (42). Read more about this study
- Who is it for?
- Ages 23 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Obesity, Weight Loss
- What is being tested?
- Exercise and weight loss intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 23 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be eligible for the study, women must be less than 3 weeks postpartum, between the ages of 23 to 40, with a body mass index (BMI) between 25 and 30 kgm-2), exclusively breastfeeding, sedentary for the past 3 months (< 3 weekly sessions of moderate aerobic activity), non-smokers, medically cleared for exercise by their physician, and agree to randomization.
Who cannot join
- Exclusion criteria for the study are delivery by cesarean section, have medical complications where exercise is contraindicated, or a disease that would affect hormone levels.
Trial locations and contacts
1 site in 1 country.
About this study
Approximately 8 million American women suffer from osteoporosis, and one out of every two women over the age of 50 will have an osteoporotic-related fracture in their lifetime (42). While epidemiological studies suggest that pregnancy and lactation are not associated with risk of fractures later in life, these studies did not control for site-specific decrements in bone mineral density (BMD). In addition, 55% of American women between the ages of 20 to 39 are overweight (14). Excess weight retention after pregnancy increases a woman's risk for developing a chronic disease later in life (44). There is a paucity of research on exercise and dietary interventions in postpartum lactating women aimed at promotion of bone health and weight loss.
The goal of this study is to promote long-term lifestyle changes through a home based strength training, aerobic, and nutrition intervention targeting overweight lactating women. The objective is to attenuate lactation-induced bone loss and promote weight loss. We hypothesize that the intervention group will lose a greater amount of fat mass while preserving lean mass and bone mineral mass and increase levels of anabolic hormones through diet and exercise compared to the minimal care group. Additionally, the acquisition of such knowledge is unique since no other studies have measured growth hormone and insulin-like growth factor-1 in lactating women with respect to bone and exercise. This intervention will encourage breastfeeding, weight loss and an increase in bone density resulting in healthy infants and mothers.
The proposed research is the first to examine the effects of a resistance exercise and weight loss intervention on attenuation of lactation-induced bone loss in overweight women. To our knowledge, this is the first study to use MyPyramid for Menu Planner for Moms for dietary counseling using the total diet approach. The expected outcomes are the intervention group will lose weight while preserving lean body mass, bone mineral mass and increase cardiovascular fitness and strength compared to the minimal care group. Additionally, the exercise group will improve the overall quality of their diet using internet based technology. An increase in activity and promotion of weight loss through a modest reduction in calories may lead to overall improvement of the mother's bone and health status later in life.
Read the detailed description
Participants will be randomized, stratified by parity, into either an intervention or minimal care group after all baseline measurements are complete (3 +/- 1 wk postpartum).
The specific aims of this project are to evaluate in overweight lactating women at 3 and 20 weeks postpartum (PP) whether an exercise and weight loss intervention, compared to a minimal care group, will:
- Improve body composition. The working hypothesis for this aim is the intervention group will lose less lean body mass and bone mineral mass and promote more fat loss compared to the minimal care group at 20 weeks PP.
- Promote an increase in cardiovascular fitness and strength. The working hypothesis for this aim is the intervention group will increase predicted maximal oxygen consumption and maximal strength compared to the minimal care group at 20 weeks PP.
- Affect bone-related hormones. The working hypothesis for this aim is the intervention group will increase growth hormone and insulin-like growth factor-1 compared to the minimal care group at 20 weeks PP.
- Improve total diet or overall pattern of food eaten. The working hypothesis for this aim, based on menu modeling with MyPyramid (16), is the intervention group will improve the quality of their intake by consuming the recommended amounts of food groups established by MyPyramid compared to the minimal care group at 20 weeks PP.
- Conditions
- Osteoporosis, Obesity, Weight Loss
- Being tested
- Exercise and weight loss intervention
- Keywords
- breastfeeding, bone mineral density, exercise, diet
- Medical subject headings
- Osteoporosis, Obesity, Weight Loss, 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 weight loss interventionOther
Also called BH2
randomized control trial, stratified by parity
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | The minimal care group will receive standard public health information on nutrition from the American Heart Association twice during the 16-week intervention. Upon completion of the endpoint measurement (20 weeks postpartum), they will be given all intervention materials. Receives: Other: Exercise and weight loss intervention |
| Exercise Group | Experimental | The intervention group will participate in a 16-week exercise and diet intervention from 4 to 20 weeks postpartum. The PI will travel to the participant's homes three times per week during the 16-week intervention to guide mothers with the exercise program, ensure dietary compliance, and provide social support. The 16-week exercise protocol consists of strength training three times per week and walking 10,000 steps per day at least five days per week. Receives: Other: Exercise and weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density-Total Body
The results reported are percent change in total body bone mineral density.
Measured: Measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)
Bone Mineral Density-lumbar Spine
Bone mineral density was measured at the lumbar spine. The results reported are the percent change in bone mineral density.
Measured: Measured at baseline (4 weeks postpartum) and endpoint (20 weeks postpartum)
Secondary outcomes (1)
Body Composition
outcome reported as percent change in percent body fat
Measured: measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startOct 2008
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoporosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina State Agricultural Research Service
- Responsible party
- Principal investigator, Cheryl A Lovelady, PhD RD, University of North Carolina, Greensboro
- Investigators
- Cheryl A Lovelady, PhD RD, Principal investigator, UNC Greensboro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966381
- Sponsor's protocol ID
- 06-0259
- Acronym
- BEHIP
- Status last verified
- Jul 2022
- First submitted
- 25 Aug 2009
- Last updated
- 15 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!
- ClinicalTrials.gov ID
- NCT00966381
- Acronym / sponsor ID
- BEHIP / 06-0259
- Conditions
- Osteoporosis, Obesity, Weight Loss
- Keywords
- breastfeeding, bone mineral density, exercise, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Collaborators
- North Carolina State Agricultural Research Service
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Aug 2009 (estimated)
- Results
- Posted 15 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 8 million American women suffer from osteoporosis, and one out of every two women over the age of 50 will have an osteoporotic-related fracture in their lifetime (42). While epidemiological studies suggest that pregnancy and lactation are not associated with risk of fractures later in life, these studies did not control for site-specific decrements in bone mineral density (BMD). In addition, 55% of American women between the ages of 20 to 39 are overweight (14). Excess weight retention after pregnancy increases a woman's risk for developing a chronic disease later in life (44). There is a paucity of research on exercise and dietary interventions in postpartum lactating women aimed at promotion of bone health and weight loss.
The goal of this study is to promote long-term lifestyle changes through a home based strength training, aerobic, and nutrition intervention targeting overweight lactating women. The objective is to attenuate lactation-induced bone loss and promote weight loss. We hypothesize that the intervention group will lose a greater amount of fat mass while preserving lean mass and bone mineral mass and increase levels of anabolic hormones through diet and exercise compared to the minimal care group. Additionally, the acquisition of such knowledge is unique since no other studies have measured growth hormone and insulin-like growth factor-1 in lactating women with respect to bone and exercise. This intervention will encourage breastfeeding, weight loss and an increase in bone density resulting in healthy infants and mothers.
The proposed research is the first to examine the effects of a resistance exercise and weight loss intervention on attenuation of lactation-induced bone loss in overweight women. To our knowledge, this is the first study to use MyPyramid for Menu Planner for Moms for dietary counseling using the total diet approach. The expected outcomes are the intervention group will lose weight while preserving lean body mass, bone mineral mass and increase cardiovascular fitness and strength compared to the minimal care group. Additionally, the exercise group will improve the overall quality of their diet using internet based technology. An increase in activity and promotion of weight loss through a modest reduction in calories may lead to overall improvement of the mother's bone and health status later in life.
Detailed description
Participants will be randomized, stratified by parity, into either an intervention or minimal care group after all baseline measurements are complete (3 +/- 1 wk postpartum).
The specific aims of this project are to evaluate in overweight lactating women at 3 and 20 weeks postpartum (PP) whether an exercise and weight loss intervention, compared to a minimal care group, will:
- Improve body composition. The working hypothesis for this aim is the intervention group will lose less lean body mass and bone mineral mass and promote more fat loss compared to the minimal care group at 20 weeks PP.
- Promote an increase in cardiovascular fitness and strength. The working hypothesis for this aim is the intervention group will increase predicted maximal oxygen consumption and maximal strength compared to the minimal care group at 20 weeks PP.
- Affect bone-related hormones. The working hypothesis for this aim is the intervention group will increase growth hormone and insulin-like growth factor-1 compared to the minimal care group at 20 weeks PP.
- Improve total diet or overall pattern of food eaten. The working hypothesis for this aim, based on menu modeling with MyPyramid (16), is the intervention group will improve the quality of their intake by consuming the recommended amounts of food groups established by MyPyramid compared to the minimal care group at 20 weeks PP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Exercise and weight loss interventionThe minimal care group will receive standard public health information on nutrition from the American Heart Association twice during the 16-week intervention. Upon completion of the endpoint measurement (20 weeks postpartum), they will be given all intervention materials. |
| Exercise Group | Experimental | Other: Exercise and weight loss interventionThe intervention group will participate in a 16-week exercise and diet intervention from 4 to 20 weeks postpartum. The PI will travel to the participant's homes three times per week during the 16-week intervention to guide mothers with the exercise program, ensure dietary compliance, and provide social support. The 16-week exercise protocol consists of strength training three times per week and walking 10,000 steps per day at least five days per week. |
Who may qualify
- Ages
- 23 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be eligible for the study, women must be less than 3 weeks postpartum, between the ages of 23 to 40, with a body mass index (BMI) between 25 and 30 kgm-2), exclusively breastfeeding, sedentary for the past 3 months (< 3 weekly sessions of moderate aerobic activity), non-smokers, medically cleared for exercise by their physician, and agree to randomization.
Key exclusion criteria (1 listed)
- Exclusion criteria for the study are delivery by cesarean section, have medical complications where exercise is contraindicated, or a disease that would affect 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 weight loss interventionAlso: BH2randomized control trial, stratified by parity | Other | Control, Exercise Group |
Primary outcome
Bone Mineral Density-Total Body
Time frame: Measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)
The results reported are percent change in total body bone mineral density.
Bone Mineral Density-lumbar Spine
Time frame: Measured at baseline (4 weeks postpartum) and endpoint (20 weeks postpartum)
Bone mineral density was measured at the lumbar spine. The results reported are the percent change in bone mineral density.
1 secondary outcome
Body Composition
Time frame: measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Cheryl A Lovelady, PhD RD principal investigator
UNC Greensboro
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 weight loss intervention in people with Osteoporosis and Obesity, run by University of North Carolina, Greensboro 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 May 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?
Yes. Results are posted in the registry (first posted 15 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bone Mineral Density-Total Body (time frame: Measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)). 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 15 May 2023.