Evidence-based Educational Materials and Local Resources for Improving Exercise-related Outcomes During Pregnancy

NCT03504267 | Completed

• 2 other identifiers: 16-2255P20GM1034
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the well-established benefits of physical activity, only 23% of pregnant women report exercising in accordance with guidelines recommended by the American Congress of Obstetricians and Gynecologists. Further, pregnant women report receiving little or no advice about physical activity during pregnancy from their health care provider; thus, the scientific evidence supporting physical activity during pregnancy does not appear to be translating into the clinic and the community. The goal of this project is to determine if the distribution of evidence-based educational materials and local resources will increase knowledge regarding the benefits of physical activity during pregnancy, patient-provider communication about physical activity during pregnancy, and physical activity levels during pregnancy. Hypothesis A: Pregnant women who receive evidence-based educational materials and local resources will have increased knowledge regarding the benefits of physical activity during pregnancy. Hypothesis B: Pregnant women who receive evidence-based educational materials and local resources will have more communication with their health care provider about physical activity. Hypothesis C: Pregnant women who receive educational information and local resources will report increased physical activity levels. Hypothesis D: Pregnant women who receive evidence-based educational materials and local resources will have improved pregnancy outcomes including lower gestational weight gain, lower insulin resistance (as determined by their clinical oral glucose tolerance test), and healthier neonatal birthweight.

Conditions

Pregnancy Related; Obesity

Keywords

physical activity; exercise; patient-provider communication

Outcome Measures

Primary Outcomes (2)

• Change in knowledge regarding physical activity during pregnancy

  Validated survey tools from previous studies (and tested in a separate cohort of local women)

  Change in knowledge from baseline (8-12 weeks) to late gestation (32-34 weeks)

• Change in physical activity levels

  Mi-Band devices will be worn on the wrist for one week at each time point

  Change in steps per day from baseline (8-12 weeks) to late gestation (32-34 weeks)

Secondary Outcomes (4)

• Patient-provider communication

  This will be assessed at the end of pregnancy (32-34 weeks) by both the patient and the provider

• Gestational weight gain

  Change in body weight from pre-pregnancy (self-reported at enrollment (kg) to the very end of pregnancy(~40 weeks gestation) (kg))

• Insulin resistance

  28 weeks gestation

• Infant birth weight

  At study completion, ~ 40 weeks gestation

Study Arms (2)

Physical Activity Group

EXPERIMENTAL

The PAG (physical activity) group will receive evidence-based educational information as well as a list of local resources for pursuing physical activity.

Other: Physical Activity Education and Resources

Standard of Care Group

NO INTERVENTION

The SOC (standard of care) group will receive no additional information beyond standard-of-care brochures and information

Interventions

Physical Activity Education and Resources OTHER

The intervention involves receiving evidence-based educational brochures as well as a list of local facilities where the participant can work out at no-cost to them,

Physical Activity Group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-44
• Confirmed singleton viable pregnancy
• English-Speaking

You may not qualify if:

• Multiple gestation pregnancy
• Inability to provide voluntary informed consent
• Any medical condition (pregnancy-related or not) that would preclude exercise

Sponsors & Collaborators

• Western Kentucky University: lead

Study Sites (1)

Graves Gilbert Obstetric Clinic

Bowling Green, Kentucky, 42101, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Health Resources

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Rachel A Tinius, PhD

  Western Kentucky University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 20, 2018
• Study Start: May 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)