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| Name | Class |
|---|---|
| Maryland Cigarette Restitution Fund | OTHER_GOV |
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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.
All participants will receive
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 participant's own for 4 more months and provide the study team with final weights 12 months after the start of the program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Helpline | Experimental | Participants receive 2 scheduled coaching calls/month and individualized coach-scripted feedback via emails twice/month for 6 months. |
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| Enhanced Helpline | Active Comparator | Participants receive 1 participant-initiated call/month. Additionally, the participants receive individualized coach-scripted feedback via emails twice/month for 6 months |
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| Extended Helpline | Other | Participants who achieved 2% weight loss at 2-month, will continue to Extended Helpline, where the participants can continue receiving 1-on-1 coaching through 1 participant-initiated calls per month for 6 months. |
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| CORE Helpline | Other | All participants will receive the CORE Helpline program for 2 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CORE Helpline | Behavioral | All participants will receive the Core Helpline program (CORE) for 2 months, which includes written weight loss material, use of a smartphone app, weekly text messages and email reminders and 1 optional participant-initiated coaching call per month. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight (pounds) changes at 8 months from 2-month between Enhanced Helpline and Intensive Helpline arms | Weight change for Enhanced Helpline and Intensive Helpline in early non-responders | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight (pounds) change at 5 and 12 months from 2-month between Enhanced Helpline and Intensive Helpline arms | Weight change for Enhanced Helpline and Intensive Helpline in early non-responders | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight (pounds) change from baseline to 2 months in all participants | Weight change for CORE Helpline over the first 2 months in all participants | 2 months |
| Within-program weight (pounds) changes from baseline to 5, 8, and 12 months in all programs |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Yeh, PhD | Contact | 410-614-4316 | hyeh1@jhmi.edu | |
| Linda Bunyard, MS, RD | Contact | 410-281-6168 | lbunyar1@jh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jessica Yeh, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins ProHealth | Recruiting | Baltimore | Maryland | 21207 | United States |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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All participants will receive Core Helpline intervention in the first two months. If participants achieve 2% or more weight loss in two months (i.e. early responders), they will continue to the Extended Helpline. If participants do not achieve at least 2% of weight loss in two months (i.e. early non-responders), they will be randomized to one of two stepped-up interventions: Enhanced Helpline or Intensive Helpline.
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| Extended Helpline | Behavioral | Those who achieved 2% weight loss at 2-month, will continue to Extended Helpline, where the participants can continue receiving all CORE resources including1-on-1 coaching through 1 optional participant-initiated call per month for 6 months. |
|
| Enhanced Helpline | Behavioral | Those who do not reach 2% weight loss at the end of 2 months will be randomized. Participants will continue to receive all CORE resources plus 1 optional participant-initiated call/month for 6 months. Additionally, the participants will receive 2 individualized coach-scripted feedback emails per month, and the option to receive daily text message reminders. |
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| Intensive Helpline | Behavioral | Those who do not reach 2% weight loss at the end of 2 months will be randomized. Participants will continue to receive all CORE resources plus 2 scheduled coaching calls/month for 6 months. Additionally, the participants will receive 2 individual coach-scripted feedback emails per month, and the option to receive daily text message reminders. |
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Weight change for each program over 12 months
| 12 months |