Recruiting

BlossomUP

Sponsor:

Iowa State University

Code:

NCT02909725

Conditions

Sedentary Lifestyle

Diabetes Mellitus, Gestational

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Limit accumulation of sedentary time

Walk

Normal daily routine; Usual Care

Study Details

Brief summary:

Multiple studies have demonstrated a very low prevalence of women meeting physical activity and weight gain recommendations during pregnancy. Additionally, previous Blossom Project studies have shown that when pregnant women engage in a 20 minute walk each day, they spend significantly more time sitting in addition to longer bouts of sitting resulting in increased total sedentary time. We are going to test which method works best to decrease sitting time, and how those methods effect metabolic parameters such as insulin resistance and blood glucose. This study will consist of three groups, each utilizing a commercially available fitness tracker, Fitbit. Group 1 (SR): will reduce sedentary time by interrupting prolonged sitting. Group 2 (WALK): will reduce sedentary time via walking. Group 3 (UC): will continue on with their normal daily routine; usual care.

Conditions

Sedentary Lifestyle

Diabetes Mellitus, Gestational

Study ID

NCT02909725

Start date

Feb, 2016

Status verified date

Sep, 2016

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Women pregnant with one fetus between 16 and 22 weeks of gestation
  • Receiving regular prenatal care, and physician documented approval to participate in this study
  • Only inactive women will be enrolled; "inactive" is defined as self-reported participation in less than 3 planned exercise sessions/week for < 30 minutes per day for at least 6 months prior to conception.

Exclusion Criteria:

  • History of smoking during pregnancy;
  • History of the following chronic diseases: Type 1 diabetes, cardiovascular disease or renal disease
  • Pre-pregnancy BMI > 40 kg/m2;
  • Inability to communicate due to language barrier or mental status;
  • Not having access to an UpBand compatible mobile device;
  • Any adverse reactions to armband monitors (e.g. metal allergies, electromagnetic devices)

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Limit accumulation of sedentary time

Group 1 (SR): Participants will be asked to limit the accumulation of prolonged bouts ( >50 minutes) of sedentary time.

experimental: Walk 30 minutes most days of the week

Group 2 (WALK): Participants will be asked to walk 30 minutes per day on most days of the week.

active comparator: Normal daily routine; Usual Care

Group 3 (UC): Participants will be asked to continue on with their normal daily routine. The usual care group will receive no form of intervention.

Interventions

Limit accumulation of sedentary time

Participants in this group receive a Fitbit Alta activity monitor, worn on the wrist for the entire intervention. The Alta is a fitness tracker designed to help individuals track their sedentary and physical activity behaviors when paired with an external device (e.g. iPhone, computer). The Sensewear armband and ActivPAL are not worn as part of the intervention; they are assessment tools used at the beginning and end of the study.

Each participant will have a Fitbit account set up with a Blossom Project username code to ensure privacy of the participant's identity. Participants will be asked to achieve a goal of 250 steps/hour. Using the "reminder to move" function, if a participant has not reached the hourly goal at 50 minutes, the Alta will vibrate, cueing the participant to walk.

Walk

Participants in this group receive a Fitbit Charge activity monitor. There is no "reminder to move" function on this band. The Charge, worn on the wrist for the entire intervention is a fitness tracker designed to help individuals track their physical activity when paired with an external device. The Sensewear armband and ActivPAL are not worn as part of the intervention; they are assessment tools used at the beginning and end of the study.

Each participant will have a Fitbit account set up with a Blossom Project username code to ensure privacy of the participant's identity. Participants will be asked to meet current pregnancy physical activity recommendations; walking 30 minutes, most days of the week (150 minutes/week). Participants can use the app to view their "active minutes."

Normal daily routine; Usual Care

Participants in this group will not be provided with a Fitbit Charge activity monitor, as participants will be asked to simply continue on with their normal daily routine. The Sensewear armband and ActivPAL are not worn as part of the intervention; they are assessment tools used at the beginning and end of the study.

Primary outcome measure

  • Change in Time Spent Sedentary [ Time Frame: From baseline to final data collection (week 6) ]

Central Contacts and Locations

Central contacts

Caroline McKinney, BS

515-202-5569clmck@iastate.edu

Christina Campbell, PhD

515-294-4260ccampbel@iastate.edu

Locations

Iowa State University

Recruiting

Ames, Iowa, United States, 50011

Contacts

Caroline McKinney, BS

515-202-5569clmck@iastate.edu

Christina Campbell, PhD

515-294-4260ccampbel@iastate.edu

Principal Investigator:

Christina Campbell, PhD

More Information

Sponsor

Iowa State University

Last update posted

Sep 21, 2016

Last verified

Sep, 2016

Keywords

  • Physical activity
  • Sedentary time
  • Pregnancy
  • Pregnant women
  • Weight gain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Iowa State University on 2016-09-21.