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The Blossom Project: "BlossomUP" Methods to Decrease Sedentary Time in Pregnancy (BUP)

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ClinicalTrials.gov Identifier: NCT02909725
Recruitment Status : Unknown
Verified September 2016 by Christina Campbell, Iowa State University.
Recruitment status was:  Recruiting
First Posted : September 21, 2016
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Christina Campbell, Iowa State University

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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Diabetes Mellitus, Gestational Other: Limit accumulation of sedentary time Other: Walk Other: Normal daily routine; Usual Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Blossom Project: "BlossomUP" Evaluating Methods to Decrease Sedentary Time in Pregnancy
Study Start Date : February 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: 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.


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.
Other: 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."


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.
Other: 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 Measures :
  1. Change in Time Spent Sedentary [ Time Frame: From baseline to final data collection (week 6) ]
    Change in time spent sedentary as measured by data collected via ActivPAL analysis.


Secondary Outcome Measures :
  1. Maternal Insulin Resistance [ Time Frame: Maternal 24th-28th week of gestation ]
    Plasma glucose concentrations and insulin resistance as measured from a oral glucose tolerance test.


Other Outcome Measures:
  1. Maternal Body Weight Change [ Time Frame: From baseline to final data collection (week 6) ]
    Gestational weight gain as measured by final data collection (week 6) weight minus self-reported pre-pregnancy weight.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909725


Contacts
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Contact: Caroline McKinney, BS 515-202-5569 clmck@iastate.edu
Contact: Christina Campbell, PhD 515-294-4260 ccampbel@iastate.edu

Locations
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United States, Iowa
Iowa State University Recruiting
Ames, Iowa, United States, 50011
Contact: Caroline McKinney, BS    515-202-5569    clmck@iastate.edu   
Contact: Christina Campbell, PhD    515-294-4260    ccampbel@iastate.edu   
Principal Investigator: Christina Campbell, PhD         
Sponsors and Collaborators
Iowa State University
Investigators
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Principal Investigator: Christina Campbell, PhD Iowa State University

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Responsible Party: Christina Campbell, Associate Professor, Iowa State University
ClinicalTrials.gov Identifier: NCT02909725     History of Changes
Other Study ID Numbers: #15-749
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christina Campbell, Iowa State University:
Physical activity
Sedentary time
Pregnancy
Pregnant women
Weight gain

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications