Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06151145
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-11-21
Brief Title:
Stepped Care for Weight Loss Maintenance
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Stepped Care for Weight Loss Maintenance
Status:
RECRUITING
Status Verified Date:
2024-02
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:
This study is a 3-group parallel design randomized controlled trial RCT in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a 5 weight loss
16-week run-in Phase 1 To qualify for randomization participants must lose 5 of initial weight in the 16-week run-in This loss will be achieved with the provision of weekly-group lifestyle counseling which includes a partial meal replacement diet
52-week randomized trial of 3 weight loss maintenance strategies Phase 2 Participants who have achieved 5 weight loss during Phase 1 will be randomly assigned to 1 of 3 groups
1 Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss
2 Participants in the SELF group will receive a wireless smart body weight scale and a wearable physical activity tracker and daily text messages with tailored feedback to assist in weight loss maintenance
3 Participants in the STEP group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment After 13 weeks at each step participants who do not maintain a 5 weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step Participants who maintain weight loss will stay at the same step
16-week run-in Phase 1 To qualify for randomization participants must lose 5 of initial weight in the 16-week run-in This loss will be achieved with the provision of weekly-group lifestyle counseling which includes a partial meal replacement diet
52-week randomized trial of 3 weight loss maintenance strategies Phase 2 Participants who have achieved 5 weight loss during Phase 1 will be randomly assigned to 1 of 3 groups
1 Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss
2 Participants in the SELF group will receive a wireless smart body weight scale and a wearable physical activity tracker and daily text messages with tailored feedback to assist in weight loss maintenance
3 Participants in the STEP group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment After 13 weeks at each step participants who do not maintain a 5 weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step Participants who maintain weight loss will stay at the same step
Detailed Description:
None
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 |
|---|---|---|---|
| R01NR020197 | NIH | None | httpsreporternihgovquickSearchR01NR020197 |