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| Name | Class |
|---|---|
| North Carolina State Agricultural Research Service | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | 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. |
|
| Exercise Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise and weight loss intervention | Other | randomized control trial, stratified by parity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density-Total Body | The results reported are percent change in total body bone mineral density. | Measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum) |
| 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. | Measured at baseline (4 weeks postpartum) and endpoint (20 weeks postpartum) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition | outcome reported as percent change in percent body fat | measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl A Lovelady, PhD RD | UNC Greensboro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC-Greensboro | Greensboro | North Carolina | 27412 | United States |
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Participants were recruited from physicians' offices and childbirth classes. Recruitment was from 2008-2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Mineral Density-Total Body | The results reported are percent change in total body bone mineral density. | Posted | Mean | Standard Deviation | percent change in BMD (g/cm2) | Measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum) |
|
Data were collected from baseline to endpoint measurements, which was 5 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheryl Lovelady | UNC Greensboro | 336 256-0310 | cheryl_lovelady@uncg.edu |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D001942 | Breast Feeding |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | percent change in BMD (g/cm^2) | Measured at baseline (4 weeks postpartum) and endpoint (20 weeks postpartum) |
|
|
|
|
| Secondary | Body Composition | outcome reported as percent change in percent body fat | Posted | Mean | Standard Deviation | percentage of change in percent fat | measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum) |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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. | 0 | 16 | 0 | 16 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D005247 | Feeding Behavior |
| D001519 | Behavior |