Physical ActivityFFTNCT03302377
Fit for Two: Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes (FFT)
A study testing physical activity counseling & Fitbit in people with Physical Activity and Type 2 Diabetes Mellitus, run by University of California, San Diego at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Physical Activity, Type 2 Diabetes Mellitus
- What is being tested?
- physical activity counseling & Fitbit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2017to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any medical condition that would make unsupervised activity unsafe or unfeasible, as determined by their physician
- moving from the area within 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093-0628
About this study
Official title: Fit for Two: Feasibility and Acceptability of Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes
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
Read the 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
- Being tested
- physical activity counseling & Fitbit
- Keywords
- Feasibility
- Medical subject headings
- Motor Activity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity counseling & FitbitBehavioural
Participants will receive individual counseling \& guidance in goal setting, then will receive a Fitbit wrist monitor and guidance in personalizing the Fitbit features
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | 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. Receives: Behavioral: physical activity counseling & Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Determined by retention (%)
Measured: 12 weeks
Acceptability
Determined by participant feedback (% indicating satisfaction with intervention)
Measured: 12 weeks
Feasibility of recruitment
Determined by percent of those screened who enroll in the study
Measured: baseline
Secondary outcomes (1)
Physical activity change
Change in objectively measured physical activity from baseline to follow-up as measured by hip-worn ActiGraph GT3X+ accelerometers, adjusting for baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start3 Oct 2017
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- As this is a feasibility study, all participants will receive the intervention
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Britta Larsen, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302377
- Sponsor's protocol ID
- CFM281R
- Acronym
- FFT
- Status last verified
- Nov 2019
- First submitted
- 29 Sep 2017
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Publications
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.
PubMed 33084584
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fit for Two: Feasibility and Acceptability of Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes
- ClinicalTrials.gov ID
- NCT03302377
- Acronym / sponsor ID
- FFT / CFM281R
- Conditions
- Physical Activity, Type 2 Diabetes Mellitus
- Keywords
- Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- As this is a feasibility study, all participants will receive the intervention
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Behavioral: physical activity counseling & FitbitParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- any medical condition that would make unsupervised activity unsafe or unfeasible, as determined by their physician
- moving from the area within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activity counseling & FitbitParticipants will receive individual counseling \& guidance in goal setting, then will receive a Fitbit wrist monitor and guidance in personalizing the Fitbit features | Behavioural | Physical activity intervention |
Primary outcome
Retention
Time frame: 12 weeks
Determined by retention (%)
Acceptability
Time frame: 12 weeks
Determined by participant feedback (% indicating satisfaction with intervention)
Feasibility of recruitment
Time frame: baseline
Determined by percent of those screened who enroll in the study
1 secondary outcome
Physical activity change
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Derived from this study: PubMed 33084584Larsen 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity counseling & Fitbit in people with Physical Activity and Type 2 Diabetes Mellitus, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03302377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.