Ignite Creation Date:
2024-07-17 @ 11:09 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484621
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Motivating Increases in Physical Activity for Prevention of Weight Regain After Metabolic Bariatric Surgery
Sponsor:
Hartford Hospital
Organization:
Hartford Hospital
Study Overview
Official Title:
Using Acceptance and Commitment Therapy to Promote Autonomous Motivation for Increased Physical Activity and Improved Weight Loss Maintenance in Bariatric Surgery Patients A Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The goal of this clinical trial is to learn if a psychological intervention can increase regular physical activity to help prevent weight regain after metabolic bariatric surgery in adults The main questions it aims to answer are
1 Does the psychological intervention increase physical activity
2 Does the psychological intervention prevent weight regain
3 Does the psychological intervention increase internal motivation for physical activity and acceptance of the discomfort that can come with physical activity
Researchers will compare the psychological intervention to an educational intervention to see if the psychological intervention works to increase physical activity and prevent weight regain after metabolic bariatric surgery
Participants will
Complete 12 months of either the psychological or control intervention This includes attending education and counseling workshops with a small group of participants and completing brief homework assignments and individual telephone calls with a counselor
Wear a device to measure physical activity use an electronic scale to measure body weight and complete questionnaires at home on five separate occasions over an 18-month period
1 Does the psychological intervention increase physical activity
2 Does the psychological intervention prevent weight regain
3 Does the psychological intervention increase internal motivation for physical activity and acceptance of the discomfort that can come with physical activity
Researchers will compare the psychological intervention to an educational intervention to see if the psychological intervention works to increase physical activity and prevent weight regain after metabolic bariatric surgery
Participants will
Complete 12 months of either the psychological or control intervention This includes attending education and counseling workshops with a small group of participants and completing brief homework assignments and individual telephone calls with a counselor
Wear a device to measure physical activity use an electronic scale to measure body weight and complete questionnaires at home on five separate occasions over an 18-month period
Detailed Description:
Nearly one in five US adults have severe obesity Body Mass Index 35 kgm2 which is related to numerous comorbidities and reduced life expectancy Metabolic and bariatric surgery MBS reliably produces substantial durable weight loss and health improvements for the majority of patients with severe obesity However weight regain over time is common and can develop into a serious complication marked by reemergence of comorbidities and impaired physical and mental quality of life This issue is compounded by a lack of effective and accessible strategies to help MBS patients prevent weight regain and achieve lifelong success Indeed current post-surgical guidelines advise that patients increase moderate-to-vigorous intensity physical activity MVPA for weight loss maintenance and lifelong health but most do not and available interventions do not address their reported low internal drive to engage in regular MVPA Acceptance and Commitment Therapy ACT-based interventions are effective at promoting health behavior changes via improved autonomous or internal motivation ACT achieves this by clarifying personal values linking behavioral performance to those values and increasing acceptance of contrary thoughts and emotions that act as barriers to new behavior engagement We pilot-tested a one-time group-based ACT-based workshop intervention email feedback amp support phone calls to increase MVPA among low-active adults with obesity Participants on average achieved and maintained clinically important increases in MVPA and autonomous motivation and larger improvements in motivation were related to larger MVPA increases These preliminary results show potential for our approach to help MBS patients boost autonomous motivation for achieving sustainable increases in MVPA Further our low-touch approach makes it ideal for reducing barriers to participation and future application in MBS and other clinical settings We now propose to build on our findings by testing whether targeting MBS patients autonomous motivation with ACT-based intervention produces sustained increases in MVPA and if such increases prevent weight regain after MBS We will randomize 164 patients who are 10-20 months post-MBS and show relative weight stability to 12 months of ACT targeting autonomous motivation for MVPA or contact-matched control CON providing PA-focused education and prescribed goals Both groups will 1 receive group-based workshops via Zoom video conferencing email feedback and homework assignments and individual telephone counseling calls and 2 be assessed at pre- and 3 6 12 and 18-months post-randomization We will compare ACT and CON on changes in 1 MVPA and weight regain primary outcomes and 2 autonomous motivation and acceptance secondary outcomes We will also explore mediators of the treatment effect on MVPA motivation acceptance and weight regain MVPA If successful results could justify more robust physical activity guidelines and use of these strategies in clinical practice to help motivate MBS patients to achieve sustainable increases in MVPA for weight regain prevention
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 |
|---|---|---|---|
| 1R01DK135463-01A1 | NIH | None | None |