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

Type 2 Diabetes Mellitus Clinical Trial

— FFT  

Official title:

Fit for Two: Feasibility and Acceptability of Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302377
• Other study ID #: CFM281R
• Status: Completed
• Phase: N/A
• Start date: October 3, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: November 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Physical Activity
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• physical activity counseling & Fitbit
Participants will receive individual counseling & guidance in goal setting, then will receive a Fitbit wrist monitor and guidance in personalizing the Fitbit features

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Determined by retention (%)	12 weeks
Primary	Acceptability	Determined by participant feedback (% indicating satisfaction with intervention)	12 weeks
Primary	Feasibility of recruitment	Determined by percent of those screened who enroll in the study	baseline
Secondary	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	12 weeks