Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751656
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2021-02-09
Brief Title:
Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment STEADY
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEADY
Brief Summary:
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
Detailed Description:
To prevent weight gain while overcoming these common barriers to engaging in weight management interventions we propose an intervention that prescribes self-weighing but does not prescribe changes in diet or physical activity behaviors or require attendance at didactic-focused meetings The potential of self-weighing to promote weight management is supported both by self-regulatory theory and empirical research Promoting self-weighing may activate participants self-regulatory skills leading to spontaneous decisions to reduce calorie intake or increase physical activity thus preventing further weight gain The proposed intervention will also provide individuals with text message-based feedback to promote continued self-weighing and to motivate engagement with evidence-based resources for weight management at a time when they may be more open to using these resources-eg after experiencing a small weight gain The current proposal will investigate the feasibility and acceptability of this low burden self-weighing intervention in order to prepare for a fully-powered pragmatic randomized controlled trial We will enroll 40 patients with either obesity or overweight with a weight-related comorbidity and who have declined to participate in a comprehensive behavioral weight management program Participants will be asked to weigh themselves daily via a smart scale that transmits weight data directly to the study team via the cellular network Every-other week participants will be sent text messages providing brief feedback encouraging continued self-weighing Moreover if a small weight gain is observed participants will be sent text messages aiming to engage them in commercial or community-based evidence-based weight management resources In a single-arm design all enrolled participants will receive the intervention for 12 months and will complete assessments at 3 and 12 months to assess feasibility and acceptability of the intervention and trial design while weight will be obtained from participants Electronic Health Records EHR We will evaluate our success in meeting pre-specified metrics for trial feasibility and intervention acceptability outcomes including intervention enrollment intervention satisfaction and obtainment of weight data abstracted from participants EHRs We will also evaluate the success of the intervention in promoting regular self-weighing and use of evidence-based weight management resources
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R03HL154272-02 | NIH | None | None |
| AWD08696 | OTHER | UFIRST Awards | httpsreporternihgovquickSearch5R03HL154272-02 |