Trial Outcomes & Findings for A Virtual Support Pilot Program for Weight Loss Surgery Patients (NCT NCT01770366)
NCT ID: NCT01770366
Last Updated: 2015-03-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
3 months post surgery
Results posted on
2015-03-13
Participant Flow
Participant milestones
| Measure |
Usual Care
Patients will receive usual care from the post-surgical clinic team.
Usual Care
|
Intervention Condition
Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.
Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Virtual Support Pilot Program for Weight Loss Surgery Patients
Baseline characteristics by cohort
| Measure |
Usual Care
n=4 Participants
Patients will receive usual care from the post-surgical clinic team.
Usual Care
|
Intervention Condition
n=6 Participants
Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.
Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post surgeryOutcome measures
| Measure |
Usual Care
n=2 Participants
Patients will receive usual care from the post-surgical clinic team.
Usual Care
|
Intervention Condition
n=5 Participants
Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.
Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired.
|
|---|---|---|
|
BMI
|
35.1 kg/m2
Standard Deviation 2.7
|
33.9 kg/m2
Standard Deviation 2.5
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place