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Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too! (BEHIP)

Primary Purpose

Osteoporosis, Obesity, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise and weight loss intervention
Sponsored by
University of North Carolina, Greensboro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring breastfeeding, bone mineral density, exercise, diet

Eligibility Criteria

23 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • To be eligible for the study, women must be less than 3 weeks postpartum, between the ages of 25 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:

  • 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.

Sites / Locations

  • UNC-Greensboro

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Exercise Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Bone Mineral Density-Total Body
The results reported are percent change in total body bone mineral density.
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.

Secondary Outcome Measures

Body Composition
outcome reported as percent change in percent body fat

Full Information

First Posted
August 25, 2009
Last Updated
July 7, 2022
Sponsor
University of North Carolina, Greensboro
Collaborators
North Carolina State Agricultural Research Service
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1. Study Identification

Unique Protocol Identification Number
NCT00966381
Brief Title
Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!
Acronym
BEHIP
Official Title
Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Greensboro
Collaborators
North Carolina State Agricultural Research Service

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Obesity, Weight Loss
Keywords
breastfeeding, bone mineral density, exercise, diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
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.
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise and weight loss intervention
Other Intervention Name(s)
BH2
Intervention Description
randomized control trial, stratified by parity
Primary Outcome Measure Information:
Title
Bone Mineral Density-Total Body
Description
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)
Title
Bone Mineral Density-lumbar Spine
Description
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)
Secondary Outcome Measure Information:
Title
Body Composition
Description
outcome reported as percent change in percent body fat
Time Frame
measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl A Lovelady, PhD RD
Organizational Affiliation
UNC Greensboro
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC-Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27412
Country
United States

12. IPD Sharing Statement

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Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!

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