Overweight and Obesity Clinical Trial
— STEADYOfficial title:
Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment
Verified date | December 2023 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this pilot trial is to pilot test an intervention to help prevent weight gain or produce weight loss among adults with obesity. Participants are asked to self-weigh on a smart scale for one year. Feasibility and acceptability outcomes are examined.
Status | Completed |
Enrollment | 39 |
Est. completion date | January 31, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Age 18-70 - Body weight recorded in EHR in the prior month from a primary care setting. - Last BMI in EHR either =30 kg/m2 or between 25.0-29.9 kg/m2 with documented weight-related comorbidity (hypertension, type II diabetes, pre-diabetes, dyslipidemia, sleep apnea). - Weight = 375 lbs. - Self-report sending and receiving at least one text message per month for past 6 months. - Not currently enrolled in comprehensive behavioral weight loss treatment. - Respond "no" to question asking if they would like to enroll in a comprehensive weight loss program in the next month - Has not engaged in self-weighing = 5 times per week on average over prior month. - Not pregnant, breastfeeding, or planning to become pregnant in next 6 months. - Not currently undergoing radiation or chemotherapy for cancer. - No history of eating disorders. - Interested in enrolling in low-burden self-weighing intervention. - Able to read and understand English without help Exclusion criteria: - History of Congestive Heart Failure or heart attack in past 6 months. - Planning to move out of the region in the following 12 months - Answer incorrectly on an attention check/ validation survey item |
Country | Name | City | State |
---|---|---|---|
United States | UF Health at the University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intervention Satisfaction | (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. |
12 months. | |
Secondary | Retention in Study | 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.) | 12 months | |
Secondary | Engagement in Self Weighing, First Quarter | days/week in which weight was registered | months 0-3 | |
Secondary | Engagement in Self Weighing, Final Quarter | mean days per week in which weight was registered | months 9-12 | |
Secondary | Percent of Patients Who Enroll | Percent of those who are eligible who are interested in and enroll in the Steady Intervention out of those who complete the screening measure. | at recruitment | |
Secondary | Representatives of Those Who Enroll | Percent of those participants who enroll who are male. | At recruitment | |
Secondary | Use of Evidence-based Resources Offered | Percent of patients who initiate use of comprehensive weight loss program | 12 months |
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