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

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT03302377

Collaborator

(none)

Enrollment

Location

Arm

24.9

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Physical Activity Type 2 Diabetes Mellitus	Behavioral: physical activity counseling & Fitbit	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

As this is a feasibility study, all participants will receive the interventionAs this is a feasibility study, all participants will receive the intervention

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 3, 2017

Actual Primary Completion Date :

Oct 31, 2019

Actual Study Completion Date :

Oct 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physical activity intervention 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.	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

Arm

Intervention/Treatment

Experimental: Physical activity intervention

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.

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

Outcome Measures

Primary Outcome Measures

Retention [12 weeks]
Determined by retention (%)
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	La Jolla	California	United States	92093-0628

Sponsors and Collaborators

University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Britta Larsen, Assistant Professor, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT03302377

Other Study ID Numbers:

CFM281R

First Posted:

Oct 5, 2017

Last Update Posted:

Nov 21, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Britta Larsen, Assistant Professor, University of California, San Diego

Feasibility

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 21, 2019