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

Not Applicable

Completed

• Conditions: Physical Activity; Type 2 Diabetes Mellitus
• Interventions: Behavioral: physical activity counseling & Fitbit

• Registration Number: NCT03302377
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study First Submitted: 2017-09-29
• Study Start: 2017-10-03
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-05
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-20
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physical activity intervention	physical activity counseling & Fitbit	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.

Primary Outcome Measures

Name	Time	Method
Acceptability	12 weeks	Determined by participant feedback (% indicating satisfaction with intervention)
Feasibility of recruitment	baseline	Determined by percent of those screened who enroll in the study
Retention	12 weeks	Determined by retention (%)

Secondary Outcome Measures

Name	Time	Method
Physical activity change	12 weeks	Change in objectively measured physical activity from baseline to follow-up as measured by hip-worn ActiGraph GT3X+ accelerometers, adjusting for baseline

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States