An mHealth Intervention for Sedentary Behavior in Pregnant Women

NCT04903574 | Completed

• 1 other identifier: Pro00110591
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnancy outcomes, such as excessive gestational weight gain and gestational diabetes, are linked to long and short-term maternal and child health. Interventions aimed at improving health behaviors, such as sedentary behavior (SB; i.e., any behavior in a seated or reclining position with low energy expenditure) are attractive because they are low-cost, can be disseminated in a wide variety of populations once pregnancy begins, and do not require drugs or prescriptions. Studies have linked SB to some pregnancy outcomes. To the investigators' knowledge, no studies have tested the efficacy of an intervention to reduce SB in pregnant women. Over 90% of reproductive aged women own a smartphone with similar rates of ownership among black, white, and Hispanic/Latina women, and most adults carry smartphones while awake. Smartphones can monitor SB without additional equipment. Thus, smartphones offer a streamlined opportunity to intervene on SB. The purpose of the research is to evaluate the effectiveness and perception of an mHealth intervention aimed at changing SB in pregnant women. Investigators will survey providers regarding their SB opinions and counseling practices

Conditions

Pregnancy Related; Sedentary Behavior

Keywords

Pregnancy; Smartphone; mHealth

Outcome Measures

Primary Outcomes (3)

• Time spent in sedentary behavior

  Total minutes/day in sedentary behavior

  Week 11-12 of the intervention

• Weight gain

  Pregnancy weight gain

  At delivery

• Glucose tolerance test results

  The blood glucose level at the third trimester glucose tolerance test

  At clinic 1 ay visit glucose test

Secondary Outcomes (3)

• Pregnant patients' opinions of sedentary behavior

  Baseline (before randomization)

• Pregnant patients' opinions of the NEAT!2 app

  Week 12

• Providers' opinions and practices regarding sedentary behavior

  until study is completed; about 1 year

Study Arms (2)

Sedentary behavior smartphone app

EXPERIMENTAL

This arm will be assigned to download and use a smartphone app that prompts you to stand up when your smartphone detects 30 minutes of sitting.

Behavioral: NEAT!2 sedentary behavior app

Pregnancy smartphone app

ACTIVE COMPARATOR

This arm will download and use a commercially available pregnancy smartphone app that does not attempt to change activity behavior.

Other: Pregnancy smartphone app

Interventions

NEAT!2 sedentary behavior app BEHAVIORAL

This is a smartphone app that reminds you to stand up if you've been sitting for at least 30 minutes.

Sedentary behavior smartphone app

Pregnancy smartphone app OTHER

This is a commercially available general pregnancy smartphone app

Pregnancy smartphone app

Eligibility Criteria

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

You may qualify if:

• currently \<16 weeks pregnant with a single infant
• at least 18 years old
• normal weight, overweight, or obese body mass index prior to pregnancy
• can read English at a 6th grade level
• planning to continue pregnancy to term
• owns smartphone and keeps it within arms reach during the day
• willing to allow medical chart access for specific information during the current pregnancy
• no absolute contraindications to exercise, i.e., a doctor has not told you not to exercise during pregnancy

You may not qualify if:

• pre-pregnancy BMI \<18.5 kg/m2
• age \<18 years
• gestational age \>16 weeks
• multiple gestation
• not planning to continue pregnancy to term
• does not own a smartphone or keep smartphone within arms-reach during the day
• pre-pregnancy type I or II diabetes
• absolute contraindication to PA in pregnancy
• not receiving prenatal care or not willing to allow access to medical chart
• inability to read English at a 6th grade level.

Sponsors & Collaborators

• University of South Carolina: lead
• Prisma Health-Midlands: collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Abbi D Lane-Cordova, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 26, 2021
• Study Start: December 17, 2021
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

US (1)