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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: Completed NA study, sponsored by University of North Carolina, Greensboro.
NCT00966381 is a NA study that has completed, run by University of North Carolina, Greensboro. The registered enrollment target is 31 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The results reported are percent change in total body bone mineral density.
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 |
What the finished NCT00966381 record still lists
NCT00966381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Exercise and weight loss intervention is the first listed.
NCT00966381 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00966381's enrollment target sits among peer trials
31 1592nd of 2000 higher than 408 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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