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

NCT ID: NCT03302377

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-03
• Study Completion Date: 2019-10-31

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.

Conditions

Physical Activity; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

physical activity counseling & Fitbit

Intervention Type: BEHAVIORAL

Participants will receive individual counseling \& guidance in goal setting, then will receive a Fitbit wrist monitor and guidance in personalizing the Fitbit features

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Britta Larsen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California, San Diego

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33084584 (View on PubMed)

Other Identifiers

CFM281R

Identifier Type: -

Identifier Source: org_study_id