Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!
Condition: Osteoporosis; Obesity; Weight Loss
MeSH terms: Osteoporosis; Weight Loss
Study type: Interventional

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:

        1. 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.

        2. 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.

        3. 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.

        4. 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.
    

Intervention name(s): Exercise and weight loss intervention
Intervention type(s): Other
Intervention description(s): randomized control trial, stratified by parity
Other intervention name(s): BH2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breastfeeding; bone mineral density; exercise; diet