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NCT00966381 · ClinicalTrials.gov registry record · NA
Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!
A NA study, sponsored by University of North Carolina, Greensboro.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT00966381 is a NA study that has completed, run by University of North Carolina, Greensboro. The registered enrollment target is 31 participants.
The verdict
NCT00966381, a NA study, has completed, sponsored by University of North Carolina, Greensboro.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study 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
Interventions
- OTHER Exercise and weight loss intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-10 |
| Est. Completion | 2010-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00966381
The ClinicalTrials.gov registry entry for NCT00966381 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Greensboro, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Exercise and weight loss intervention is the first listed.
NCT00966381 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00966381 about?
NCT00966381 is a clinical study titled "Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!". 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 ...
What is the current status of trial NCT00966381?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2008-10. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00966381?
The interventions under investigation include: Exercise and weight loss intervention (OTHER).
Who is sponsoring clinical trial NCT00966381?
This trial is sponsored by University of North Carolina, Greensboro, which has 15 total clinical trials registered on ClinicalTrials.gov.
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