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

University of California San Diego

Status: Completed

Conditions: Physical Activity; Type 2 Diabetes Mellitus

Treatments: Behavioral: physical activity counseling & Fitbit

Study type: Interventional

Funder types: Other

Identifiers

NCT03302377

CFM281R

Details and patient eligibility

About

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

Full 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.

Enrollment: 19 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Physical activity intervention

Experimental group

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.

Treatment:

Behavioral: physical activity counseling & Fitbit