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| Sponsor: | University of North Carolina, Greensboro |
|---|---|
| Collaborator: |
North Carolina State Agricultural Research Service |
| Information provided by: | University of North Carolina, Greensboro |
| ClinicalTrials.gov Identifier: | NCT00966381 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoporosis Obesity Weight Loss Body Composition |
Other: Exercise and weight loss intervention |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too! |
| Estimated Enrollment: | 44 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Control: No Intervention
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.
|
Other: Exercise and weight loss intervention
randomized control trial, stratified by parity
|
|
Exercise Group: Experimental
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.
|
Other: Exercise and weight loss intervention
randomized control trial, stratified by parity
|
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:
Eligibility| Ages Eligible for Study: | 23 Years to 37 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cheryl A Lovelady, PhD RD | 336-256-0310 | cheryl_lovelady@uncg.edu |
| United States, North Carolina | |
| UNC-Greensboro | Recruiting |
| Greensboro, North Carolina, United States, 27412 | |
| Contact: Cheryl A Lovelady, PhD RD 336-256-0310 cheryl_lovelady@uncg.edu | |
| Principal Investigator: Cheryl A Lovelady, PhD RD | |
| Principal Investigator: | Cheryl A Lovelady, PhD RD | UNC-Greensboro |
More Information
| Responsible Party: | University of North Carolina, Greensboro ( Cheryl A Lovelady, PhD RD ) |
| Study ID Numbers: | 06-0259 |
| Study First Received: | August 25, 2009 |
| Last Updated: | August 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00966381 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
breastfeeding bone mineral density exercise diet |
|
Obesity Osteoporosis Overweight Bone Diseases, Metabolic Bone Diseases Body Weight Signs and Symptoms |
Musculoskeletal Diseases Weight Loss Osteoporosis, Postmenopausal Body Weight Changes Nutrition Disorders Overnutrition |