Trial Outcomes & Findings for Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients (NCT NCT02708121)
NCT ID: NCT02708121
Last Updated: 2019-06-25
Results Overview
Count of enrolled participants who attend 6 month follow-up appointment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
6 months
Results posted on
2019-06-25
Participant Flow
All six providers who were recruited through a Duke Health primary care-based research network and were present at a primary care clinic provider meeting in February 2017, were eligible and consented to participate. Patients of the enrolled providers were recruited from May 2017 to August 2017 through an electronic health record database search.
None of the providers were withdrawn from the study. Of the 66 patients initially consented, 6 withdrew prior to learning their randomization assignment; 4 chose to withdraw for no stated reason; one was withdrawn by the study team due to being in treatment; and one was withdrawn by the study team due to canceling their index appointment.
Participant milestones
| Measure |
Mobilization Tool Arm
Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.
Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment.
|
Comparator Tool Arm
Participant receives access to weight loss treatment alone.
Comparator Intervention: Participants informed that they have access to weight loss treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
31
|
|
Overall Study
Provided Acceptability Data
|
20
|
0
|
|
Overall Study
Treatment Program Use Data Available
|
34
|
24
|
|
Overall Study
6 Month In-Person Follow Up Data
|
22
|
19
|
|
Overall Study
6 Month Weight Data Via EHR
|
14
|
13
|
|
Overall Study
COMPLETED
|
34
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Mobilization Tool Arm
Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.
Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment.
|
Comparator Tool Arm
Participant receives access to weight loss treatment alone.
Comparator Intervention: Participants informed that they have access to weight loss treatment.
|
|---|---|---|
|
Overall Study
Withdrawn by Study Team
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
Baseline Characteristics
One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
Baseline characteristics by cohort
| Measure |
Mobilization Tool Arm
n=34 Participants
Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.
Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment.
|
Comparator Tool Arm
n=26 Participants
Participant receives access to weight loss treatment alone.
Comparator Intervention: Participants informed that they have access to weight loss treatment.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 14.0 • n=34 Participants • One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
|
54.9 years
STANDARD_DEVIATION 10.9 • n=25 Participants • One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
|
54.6 years
STANDARD_DEVIATION 12.7 • n=59 Participants • One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
|
|
Sex: Female, Male
Female
|
19 Participants
n=34 Participants
|
15 Participants
n=26 Participants
|
34 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=34 Participants
|
11 Participants
n=26 Participants
|
26 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic
|
23 Participants
n=34 Participants • One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
|
16 Participants
n=25 Participants • One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
|
39 Participants
n=59 Participants • One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
|
|
Race/Ethnicity, Customized
African American
|
10 Participants
n=34 Participants • One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
|
9 Participants
n=25 Participants • One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
|
19 Participants
n=59 Participants • One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
|
|
Race/Ethnicity, Customized
Other or multiple races
|
1 Participants
n=34 Participants • One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
|
0 Participants
n=25 Participants • One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
|
1 Participants
n=59 Participants • One patient in the Comparator Arm completed the screener questionnaire but did not attend baseline session. Thus data is presented for 25 of the 26 enrolled patients for all variable except gender.
|
PRIMARY outcome
Timeframe: 6 monthsCount of enrolled participants who attend 6 month follow-up appointment
Outcome measures
| Measure |
Mobilization Tool Arm
n=34 Participants
Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.
Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment.
|
Comparator Tool Arm
n=26 Participants
Participant receives access to weight loss treatment alone.
Comparator Intervention: Participants informed that they have access to weight loss treatment.
|
|---|---|---|
|
Number of Participants Attending 6 Month Follow-up Appointment
|
22 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Among mobilization tool participants, 28 patients progressed past the tool's introductory page, and 27 patients completed the tool. The post-tool acceptability survey was completed by 20 participants (72% of those who began the tool).
Ratings on series of items developed by study team to assess patient perception of acceptability of the intervention. Items were created by study team. Possible range of 1 (strongly disagree) to 5 (strongly agree). Higher score reflects greater acceptability except for item 11.
Outcome measures
| Measure |
Mobilization Tool Arm
n=20 Participants
Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.
Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment.
|
Comparator Tool Arm
Participant receives access to weight loss treatment alone.
Comparator Intervention: Participants informed that they have access to weight loss treatment.
|
|---|---|---|
|
Intervention Acceptability (Acceptability Outcome)
Item 1: Enjoyed
|
4.15 score on a item
Standard Deviation 0.67
|
—
|
|
Intervention Acceptability (Acceptability Outcome)
Item 2: Learning
|
4.05 score on a item
Standard Deviation 0.83
|
—
|
|
Intervention Acceptability (Acceptability Outcome)
Item 3: Easy to use
|
4.25 score on a item
Standard Deviation 0.72
|
—
|
|
Intervention Acceptability (Acceptability Outcome)
Item 4: Secure
|
4.30 score on a item
Standard Deviation 0.73
|
—
|
|
Intervention Acceptability (Acceptability Outcome)
Item 5: Interested
|
4.10 score on a item
Standard Deviation 0.72
|
—
|
|
Intervention Acceptability (Acceptability Outcome)
Item 6: Trustworthy
|
4.15 score on a item
Standard Deviation 0.75
|
—
|
|
Intervention Acceptability (Acceptability Outcome)
Item 7: Enough time
|
4.15 score on a item
Standard Deviation 0.75
|
—
|
|
Intervention Acceptability (Acceptability Outcome)
Item 8: Easy to understand
|
4.35 score on a item
Standard Deviation 0.59
|
—
|
|
Intervention Acceptability (Acceptability Outcome)
Item 9: Easy to navigate
|
4.40 score on a item
Standard Deviation 0.50
|
—
|
|
Intervention Acceptability (Acceptability Outcome)
Item 10: Useful
|
4.15 score on a item
Standard Deviation 0.67
|
—
|
|
Intervention Acceptability (Acceptability Outcome)
Item 11: Too long
|
2.45 score on a item
Standard Deviation 1.39
|
—
|
|
Intervention Acceptability (Acceptability Outcome)
Item 12: Enough information
|
4.10 score on a item
Standard Deviation 0.64
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Six participants withdrew prior to learning randomization condition and were not followed.
Number of participants who initiate evidence-based weight loss treatment. Initiation is defined as completing at least one session (either group in-person session, one-on-one)
Outcome measures
| Measure |
Mobilization Tool Arm
n=34 Participants
Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.
Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment.
|
Comparator Tool Arm
n=26 Participants
Participant receives access to weight loss treatment alone.
Comparator Intervention: Participants informed that they have access to weight loss treatment.
|
|---|---|---|
|
Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report
Treatment initiation, program data
|
20 Participants
|
8 Participants
|
|
Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report
Treatment initiation, self-report
|
14 Participants
|
8 Participants
|
Adverse Events
Mobilization Tool Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparator Tool Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mobilization Tool Arm
n=34 participants at risk
Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.
Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment.
|
Comparator Tool Arm
n=26 participants at risk
Participant receives access to weight loss treatment alone.
Comparator Intervention: Participants informed that they have access to weight loss treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization
|
2.9%
1/34 • Number of events 1 • 6 months (study period)
|
0.00%
0/26 • 6 months (study period)
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Megan McVay
Department of Health Education and Behavior, College of Health and Human Performance, University of Florida
Phone: (352)294-7029
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place