Trial Outcomes & Findings for Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment (STEADY) (NCT NCT04751656)

NCT ID: NCT04751656

Last Updated: 2024-01-31

Results Overview

(NOTE: this is a pilot study and there is not a true primary outcome. There are several descriptive outcomes that will inform our decision to proceed to a traditional, fully powered clincial trial). Intervention satisfaction reported here is response to item "overall, I am satisfied with this program." with response options 1-5, 1-strongly disagree, 3-neither agree nor disagree, and 5-strongly agree.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: 12 months.
• Results posted on: 2024-01-31

Participant Flow

Participant milestones

Measure	Steady Intervention Enrollees Participants who enrolled in the Steady Intervention
Overall Study STARTED	39
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Steady Intervention Enrollees Participants who enrolled in the Steady Intervention
Overall Study Lost to Follow-up	1

Baseline Characteristics

Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment (STEADY)

Baseline characteristics by cohort

Measure	Steady Intervention Enrollees n=39 Participants Participants who enrolled in the Steady Intervention
Age, Continuous	44.7 years STANDARD_DEVIATION 13.1 • n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	20 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	6 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants
Race (NIH/OMB) White	24 Participants n=93 Participants
Race (NIH/OMB) More than one race	3 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	39 participants n=93 Participants

PRIMARY outcome

Timeframe: 12 months.

Population: Those who completed 12 month assessment

(NOTE: this is a pilot study and there is not a true primary outcome. There are several descriptive outcomes that will inform our decision to proceed to a traditional, fully powered clincial trial).

Intervention satisfaction reported here is response to item "overall, I am satisfied with this program." with response options 1-5, 1-strongly disagree, 3-neither agree nor disagree, and 5-strongly agree.

Outcome measures

Measure	Steady Intervention Enrollees n=34 Participants Participants who enrolled in the Steady Intervention
Intervention Satisfaction	4.1 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 12 months

Percent of participants completing 12 month survey. (There is no measurement used for this. It is based on the portion of patients who complete the 12 month survey.)

Outcome measures

Measure	Steady Intervention Enrollees n=39 Participants Participants who enrolled in the Steady Intervention
Retention in Study	34 Participants

SECONDARY outcome

Timeframe: months 0-3

days/week in which weight was registered

Outcome measures

Measure	Steady Intervention Enrollees n=39 Participants Participants who enrolled in the Steady Intervention
Engagement in Self Weighing, First Quarter	4.9 days/week Standard Deviation 1.2

SECONDARY outcome

Timeframe: months 9-12

mean days per week in which weight was registered

Outcome measures

Measure	Steady Intervention Enrollees n=39 Participants Participants who enrolled in the Steady Intervention
Engagement in Self Weighing, Final Quarter	4.2 days/week Standard Deviation 1.7

SECONDARY outcome

Timeframe: at recruitment

Population: those who were offered steady

Percent of those who are eligible who are interested in and enroll in the Steady Intervention out of those who complete the screening measure.

Outcome measures

Measure	Steady Intervention Enrollees n=86 Participants Participants who enrolled in the Steady Intervention
Percent of Patients Who Enroll	39 Participants

SECONDARY outcome

Timeframe: At recruitment

Percent of those participants who enroll who are male.

Outcome measures

Measure	Steady Intervention Enrollees n=39 Participants Participants who enrolled in the Steady Intervention
Representatives of Those Who Enroll	20 Participants

SECONDARY outcome

Timeframe: 12 months

Percent of patients who initiate use of comprehensive weight loss program

Outcome measures

Measure	Steady Intervention Enrollees n=39 Participants Participants who enrolled in the Steady Intervention
Use of Evidence-based Resources Offered	3 Participants

Adverse Events

Steady Intervention Enrollees

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

Megan McVay

University of Florida

Phone: 352-294-1638

Email: megan.mcvay@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place