Ignite Creation Date:
2024-07-17 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463249
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
Behavioral Weight Loss for Cancer Survivors in Maryland A Trial With Adaptive Interventions
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Scaling up Behavioral Weight Loss Opportunities for Cancer Survivors With Overweight or Obesity in Maryland A Randomized Trial With Adaptive Interventions Helpline for Weight Loss
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Helpline
Brief Summary:
The objective of the HELPLINE Weight Loss Program is to determine the comparative effectiveness of two active multi-component augmented interventions for cancer survivors with overweight or obesity who do not achieve early weight loss goal in the initial intervention period termed early non-responders The core study design is randomized controlled trial with adaptive intervention
1 CORE Helpline in all participants first 2 months
2 Extended Helpline in early responders additional 6 months
3 Enhanced Helpline in early non-responders additional 6 months
4 Intensive Helpline in early non-responders additional 6 months
1 CORE Helpline in all participants first 2 months
2 Extended Helpline in early responders additional 6 months
3 Enhanced Helpline in early non-responders additional 6 months
4 Intensive Helpline in early non-responders additional 6 months
Detailed Description:
All participants will receive
written Johns Hopkins weight loss material
instructions for using a smartphone weight loss app to keep track of food and exercise every day either android or iPhone
a weekly weight loss tip by text message and email and a text message on weight loss progress each week
a research scale and specific instructions for verifying weights at 5 specific times over the next year
The participants may also request two 20-minute phone calls during the first 2 months with a weight loss coach
After the first 2 months depending on weight loss progress the participants will be assigned to another program which may include additional assistance for 6 more months
Additional assistance may include scheduled phone calls with a Johns Hopkins weight loss coach each month individualized emails from a Johns Hopkins weight loss coach and the option for daily text message reminders
After the first 8 months of assistance the participants will continue the program on the participants own for 4 more months and provide the study team with final weights 12 months after the start of the program
written Johns Hopkins weight loss material
instructions for using a smartphone weight loss app to keep track of food and exercise every day either android or iPhone
a weekly weight loss tip by text message and email and a text message on weight loss progress each week
a research scale and specific instructions for verifying weights at 5 specific times over the next year
The participants may also request two 20-minute phone calls during the first 2 months with a weight loss coach
After the first 2 months depending on weight loss progress the participants will be assigned to another program which may include additional assistance for 6 more months
Additional assistance may include scheduled phone calls with a Johns Hopkins weight loss coach each month individualized emails from a Johns Hopkins weight loss coach and the option for daily text message reminders
After the first 8 months of assistance the participants will continue the program on the participants own for 4 more months and provide the study team with final weights 12 months after the start of the program
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