Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!

NCT00966381 | Completed Results DMC

• 1 other identifier: 06-0259
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis; Obesity; Weight Loss

Keywords

breastfeeding; bone mineral density; exercise; diet

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (1)

• Body Composition

  measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)

Study Arms (2)

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.

Other: Exercise and weight loss intervention

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.

Other: Exercise and weight loss intervention

Interventions

Exercise and weight loss intervention OTHER

randomized control trial, stratified by parity

Also known as: BH2

Control; Exercise Group

Eligibility Criteria

• Age: 23 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be eligible for the study, women must be less than 3 weeks postpartum, between the ages of 23 to 40, with a body mass index (BMI) between 25 and 30 kgm-2), exclusively breastfeeding, sedentary for the past 3 months (\< 3 weekly sessions of moderate aerobic activity), non-smokers, medically cleared for exercise by their physician, and agree to randomization.

Sponsors & Collaborators

• University of North Carolina, Greensboro: lead
• North Carolina State Agricultural Research Service: collaborator

Study Sites (1)

UNC-Greensboro

Greensboro, North Carolina, 27412, United States

Location

MeSH Terms

Conditions

Osteoporosis; Obesity; Weight Loss; Breast Feeding; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Cheryl Lovelady
• Organization: UNC Greensboro

cheryl_lovelady@uncg.edu

336 256-0310

Study Officials

• Cheryl A Lovelady, PhD RD

  UNC Greensboro

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2009
• First Posted: August 26, 2009
• Study Start: October 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 15, 2023
• Results First Posted: May 15, 2023

Record last verified: 2022-07

Locations

US (1)