Skip to main content
OpenTrials
Completed

NCT Number: NCT04903574

An mHealth Intervention for Sedentary Behavior in Pregnant Women

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

Investigators will recruit 28 pregnant women, 14 per arm, to participate in this pilot randomized, controlled study. Particiants will complete an in-person baseline study visit in early pregnancy (< week 16). The visit will occur in the Public Health Research Center, Discovery Building, or at a Prisma Health facility. Measurements at the in-person visit (~ 1 hr) include demographics, surveys regarding current and pre-pregnancy PA and SB, medical and pregnancy history, height, and weight. All participants will be given an activPAL(TM) (Glasgow, UK) at V1 to objectively measure SB for 1 week using gold-standard methodology. At the end of the 1-week run-in period (i.e., the week during which SB is objectively measured prior to randomization), participants will mail back the activPAL(TM) and be randomized to the mHealth SB intervention or control group for 12 weeks. SB will be objectively measured again using the activPAL(TM) from week 11-12 of the study. Surveys (Nausea and Vomiting of Pregnancy, Global Health Scales, inquiry about new diagnoses) will be administered remotely in week 5 and week 11. A recruitment opinion survey will be administered remotely in week 5 to inform future recruitment efforts. Surveys related to the intervention platform and perceived effectiveness will be administered remotely at week 12 to participants in the experimental group. Investigators will ask about new diagnoses or adverse events at week 5 and week 11. Investigators will link to participants' medical charts and abstract in-clinic body weight, the results of the third trimester glucose tolerance test, and any other pregnancy-related diagnoses. Investigators will survey Ob/Gyn clinicians (doctors, residents, and nurses) regarding their perceptions of SB during pregnancy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Pregnancy smartphone app

Other

This is a commercially available general pregnancy smartphone app

Primary outcomes

  1. Time spent in sedentary behavior

    Time frame: Week 11-12 of the intervention

    Total minutes/day in sedentary behavior

  2. Weight gain

    Time frame: At delivery

    Pregnancy weight gain

  3. Glucose tolerance test results

    Time frame: At clinic 1 ay visit glucose test

    The blood glucose level at the third trimester glucose tolerance test

Secondary outcomes

  1. Pregnant patients' opinions of sedentary behavior

    Time frame: Baseline (before randomization)

    Survey regarding feelings about sedentary behavior during pregnancy

  2. Pregnant patients' opinions of the NEAT!2 app

    Time frame: Week 12

    Survey regarding feelings about the app for those assigned to the experimental group

  3. Providers' opinions and practices regarding sedentary behavior

    Time frame: until study is completed; about 1 year

    MD/DO, RN, NP opinions and counseling practices related to sedentary behavior in pregnant patients

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • Prisma Health-Midlands

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 26, 2021
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.