NCT02909725

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

September 16, 2016

Last Update Submit

September 20, 2016

Conditions

Sedentary LifestyleDiabetes Mellitus, Gestational

Keywords

Physical activitySedentary timePregnancyPregnant womenWeight gain

Outcome Measures

Primary Outcomes (1)

  • Change in Time Spent Sedentary

    Change in time spent sedentary as measured by data collected via ActivPAL analysis.

    From baseline to final data collection (week 6)

Secondary Outcomes (1)

  • Maternal Insulin Resistance

    Maternal 24th-28th week of gestation

Other Outcomes (1)

  • Maternal Body Weight Change

    From baseline to final data collection (week 6)

Study Arms (3)

Limit accumulation of sedentary time

EXPERIMENTAL

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

Other: Limit accumulation of sedentary time

Walk 30 minutes most days of the week

EXPERIMENTAL

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

Other: Walk

Normal daily routine; Usual Care

ACTIVE COMPARATOR

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.

Other: Normal daily routine; Usual Care

Interventions

Limit accumulation of sedentary timeOTHER

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.

Limit accumulation of sedentary time
WalkOTHER

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."

Walk 30 minutes most days of the week
Normal daily routine; Usual CareOTHER

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.

Normal daily routine; Usual Care

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorDiabetes, GestationalMotor ActivityWeight Gain

Interventions

Walking

Condition Hierarchy (Ancestors)

BehaviorPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Christina Campbell, PhD

    Iowa State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline McKinney, BS

CONTACT

515-202-5569clmck@iastate.edu

Christina Campbell, PhD

CONTACT

515-294-4260ccampbel@iastate.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 16, 2016

First Posted

September 21, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 21, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)