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Fit for Two: Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes (FFT) (FFT)

Primary Purpose

Physical Activity, Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
physical activity counseling & Fitbit
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Activity focused on measuring Feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed with type 2 diabetes or gestational diabetes
  • currently pregnant
  • in week 5-25 of gestation
  • under active (<100 minutes/week of physical activity)
  • access to a smartphone

Exclusion Criteria:

  • any medical condition that would make unsupervised activity unsafe or unfeasible, as determined by their physician
  • moving from the area within 3 months

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical activity intervention

Arm Description

Participants will receive an individual counseling session in the clinic to help them set physical activity and step goals. They will then receive a Fitbit wrist monitor and help personalizing the Fitbit app. They will send weekly emails to their physicians reporting their goals and current activity. They will return at 12 weeks to engage in a semi-structured interview to give their overall impressions of the intervention.

Outcomes

Primary Outcome Measures

Retention
Determined by retention (%)
Acceptability
Determined by participant feedback (% indicating satisfaction with intervention)
Feasibility of recruitment
Determined by percent of those screened who enroll in the study

Secondary Outcome Measures

Physical activity change
Change in objectively measured physical activity from baseline to follow-up as measured by hip-worn ActiGraph GT3X+ accelerometers, adjusting for baseline

Full Information

First Posted
September 29, 2017
Last Updated
November 20, 2019
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03302377
Brief Title
Fit for Two: Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes (FFT)
Acronym
FFT
Official Title
Fit for Two: Feasibility and Acceptability of Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will investigate the feasibility of an intervention to increase physical activity in pregnant women with diabetes by incorporating a brief in-person counseling session and Fitbit activity trackers into routine clinical care
Detailed Description
This is a small, one-armed pilot study testing a physical activity intervention for pregnant patients with diabetes. The intervention will use both counseling and technology (a FitBit physical activity tracker and smartphone app) to create an individualized, interactive program for each patient. The primary aims of the study are to assess the feasibility of recruiting patients and implementing the program in the clinical setting, and the acceptability of the program for patients and clinicians. Participants will receive a counseling session based on the principles of motivational interviewing to help them set physical activity and step goals, then the interventionist will help them personalize the Fitbit app to their goals. Participants are instructed to continue adaptive goal setting and email their goals and activity weekly to their physicians. In addition to assessing feasibility and acceptability, we will also evaluate change in activity to explore potential efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Type 2 Diabetes Mellitus
Keywords
Feasibility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
As this is a feasibility study, all participants will receive the intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical activity intervention
Arm Type
Experimental
Arm Description
Participants will receive an individual counseling session in the clinic to help them set physical activity and step goals. They will then receive a Fitbit wrist monitor and help personalizing the Fitbit app. They will send weekly emails to their physicians reporting their goals and current activity. They will return at 12 weeks to engage in a semi-structured interview to give their overall impressions of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
physical activity counseling & Fitbit
Intervention Description
Participants will receive individual counseling & guidance in goal setting, then will receive a Fitbit wrist monitor and guidance in personalizing the Fitbit features
Primary Outcome Measure Information:
Title
Retention
Description
Determined by retention (%)
Time Frame
12 weeks
Title
Acceptability
Description
Determined by participant feedback (% indicating satisfaction with intervention)
Time Frame
12 weeks
Title
Feasibility of recruitment
Description
Determined by percent of those screened who enroll in the study
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Physical activity change
Description
Change in objectively measured physical activity from baseline to follow-up as measured by hip-worn ActiGraph GT3X+ accelerometers, adjusting for baseline
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is for pregnant patients, so all participants will be female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with type 2 diabetes or gestational diabetes currently pregnant in week 5-25 of gestation under active (<100 minutes/week of physical activity) access to a smartphone Exclusion Criteria: any medical condition that would make unsupervised activity unsafe or unfeasible, as determined by their physician moving from the area within 3 months
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0628
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with other researchers
Citations:
PubMed Identifier
33084584
Citation
Larsen B, Micucci S, Hartman SJ, Ramos G. Feasibility and Acceptability of a Counseling- and mHealth-Based Physical Activity Intervention for Pregnant Women With Diabetes: The Fit for Two Pilot Study. JMIR Mhealth Uhealth. 2020 Oct 21;8(10):e18915. doi: 10.2196/18915.
Results Reference
derived

Learn more about this trial

Fit for Two: Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes (FFT)

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