Investigation of Increased Physical Activity During the Postpartum Period on Weight Loss, Body Composition, and Energy Expenditure

NCT06636305 | Completed

• 1 other identifier: 1707021250
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to investigate the impact of increased physical activity during the postpartum period on on weight loss, body composition, energy expenditure, and body image perceptions following pregnancy and childbirth. Specifically, this study utilizes a mixed methods approach including qualitative and quantitative analyses of the physiological and sociological determinants of postpartum women's health and wellness, The primary objective of the proposed project is to assess the impact of a physical activity intervention on postpartum women\'s ability to return to pre-pregnancy body weight, the resumption of normal activity and bodily function, and the improvement of body image. This objective will be achieved via the assessment of quantitative, physiological markers (i.e. physical activity level, body composition, energy expenditure, and hormone levels), as well as qualitative, sociological markers (i.e. self-report and interview data related to body image and bodily recovery) that serve as a measure of a postpartum body that has resumed relatively normal physical function and activity.

Conditions

Weight Loss; Postpartum; Physical Activity

Keywords

Postpartum; Weight Loss; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Postpartum Weight Retention

  Postpartum weight retention was calculated as the difference between the participant's postpartum weight at each visit and their self-reported pre-pregnancy weight.

  From enrollment to the end of the study at the 12 month postpartum mark

Secondary Outcomes (3)

• Postpartum Resting Energy Expenditure

  REE was measured at enrollment (i.e., 6-12 weeks postpartum) and again at 6, 9, and 12 months postpartum.

• Postpartum Body Composition

  Postpartum body composition was measured at enrollment (i.e., 6-12 weeks postpartum) and again at 6, 9, and 12 months postpartum.

• Postpartum Sleep Quality

  Postpartum sleep quality was measured at enrollment (i.e., 6-12 weeks postpartum) and again at 6, 9, and 12 months postpartum.

Study Arms (2)

physical activity intervention

EXPERIMENTAL

Women in the intervention group were instructed to obtain 10,000 steps per day and 150 minutes of MVPA (defined as physical activity that resulted in a heart rate in the range of 120-170 bmp) per week and were given a physical activity tracker (FitBit Charge HR 2, Fitbit, San Francisco, USA) to self-monitor progress.

Behavioral: physical activity intervention

control group

NO INTERVENTION

Women in the control group were given a physical activity tracker (FitBit Charge HR 2, Fitbit, San Francisco, USA) but no other physical activity instructions.

Interventions

physical activity intervention BEHAVIORAL

Women in the intervention group were instructed to obtain 10,000 steps per day and 150 minutes of MVPA (defined as physical activity that resulted in a heart rate in the range of 120-170 bmp) per week and were given a physical activity tracker (FitBit Charge HR 2, Fitbit, San Francisco, USA) to self-monitor progress.

physical activity intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 6-12 weeks postpartum following a live singleton birth.

You may not qualify if:

• inability to walk without assistance.
• not cleared by their medical provider to resume physical activity by 12 weeks postpartum.

Sponsors & Collaborators

• Nicolas D. Knuth: lead

Study Sites (1)

Towson University

Towson, Maryland, 21252, United States

Location

MeSH Terms

Conditions

Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

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

Model Details: One groups will be assigned to a physical activity intervention, the other group will serve as a control group.

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 10, 2024
• Study Start: October 17, 2017
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: October 10, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 1 year after publication with no end date
• Access Criteria: Access to study IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Please contact corresponding author for more information or to submit a request.

Locations

US (1)