Skip to content

Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!

Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00966381
Acronym
BEHIP
Enrollment
31
Registered
2009-08-26
Start date
2008-10-31
Completion date
2010-12-31
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Osteoporosis, Weight Loss

Keywords

breastfeeding, bone mineral density, exercise, diet

Brief 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). 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: 1. 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. 2. 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. 3. 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. 4. 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.

Interventions

OTHERExercise and weight loss intervention

randomized control trial, stratified by parity

Sponsors

North Carolina State Agricultural Research Service
CollaboratorUNKNOWN
University of North Carolina, Greensboro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
23 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Bone Mineral Density-Total BodyMeasured 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 SpineMeasured 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.

Secondary

MeasureTime frameDescription
Body Compositionmeasured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)outcome reported as percent change in percent body fat

Countries

United States

Participant flow

Recruitment details

Participants were recruited from physicians' offices and childbirth classes. Recruitment was from 2008-2010.

Participants by arm

ArmCount
Control
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 wks postpartum), they will be given all intervention materials.
15
Exercise Group
The intervention group will participate in a 16-week exercise and diet intervention from 4 to 20 wks 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-wk exercise protocol consists of strength training three times per week and walking 10,000 steps per day at least five days per week.
16
Total31

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject22

Baseline characteristics

CharacteristicTotalControlExercise Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
31 Participants15 Participants16 Participants
Age, Continuous31.1 years
STANDARD_DEVIATION 3.5
30.3 years
STANDARD_DEVIATION 3.8
31.9 years
STANDARD_DEVIATION 3.1
Region of Enrollment
United States
31 participants15 participants16 participants
Sex: Female, Male
Female
31 Participants15 Participants16 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 150 / 16
serious
Total, serious adverse events
0 / 150 / 16

Outcome results

Primary

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.

Time frame: Measured at baseline (4 weeks postpartum) and endpoint (20 weeks postpartum)

ArmMeasureValue (MEAN)Dispersion
ControlBone Mineral Density-lumbar Spine-3.7 percent change in BMD (g/cm^2)Standard Deviation 3.3
Exercise GroupBone Mineral Density-lumbar Spine-3.4 percent change in BMD (g/cm^2)Standard Deviation 2.5
p-value: <0.05ANOVA
Primary

Bone Mineral Density-Total Body

The results reported are percent change in total body bone mineral density.

Time frame: Measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)

ArmMeasureValue (MEAN)Dispersion
ControlBone Mineral Density-Total Body-0.3 percent change in BMD (g/cm2)Standard Deviation 2.4
Exercise GroupBone Mineral Density-Total Body-1.1 percent change in BMD (g/cm2)Standard Deviation 0.8
p-value: <0.05ANOVA
Secondary

Body Composition

outcome reported as percent change in percent body fat

Time frame: measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)

ArmMeasureValue (MEAN)Dispersion
ControlBody Composition-6.8 percentage of change in percent fatStandard Deviation 8.1
Exercise GroupBody Composition-8.2 percentage of change in percent fatStandard Deviation 11.1
p-value: <0.05ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026