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OpenTrials
Completed

NCT Number: NCT03302377

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093-0628, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physical activity counseling & Fitbit

Behavioral

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

Primary outcomes

  1. Retention

    Time frame: 12 weeks

    Determined by retention (%)

  2. Acceptability

    Time frame: 12 weeks

    Determined by participant feedback (% indicating satisfaction with intervention)

  3. Feasibility of recruitment

    Time frame: baseline

    Determined by percent of those screened who enroll in the study

Secondary outcomes

  1. Physical activity change

    Time frame: 12 weeks

    Change in objectively measured physical activity from baseline to follow-up as measured by hip-worn ActiGraph GT3X+ accelerometers, adjusting for baseline

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Acronym: FFT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2017
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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