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| ID | Type | Description | Link |
|---|---|---|---|
| 133811-RSG-19-121-01-CPPB | Other Grant/Funding Number | American Cancer Society, Inc. |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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The overall purpose of this study is to determine the efficacy of the Family Lifestyles, Actions, and Risk Education (FLARE) intervention in improving melanoma preventive behaviors. Parent-child dyads, consisting of survivors of melanoma and their children, will be randomly assigned to either receive the FLARE intervention or standard education. Once enrolled, each parent-child dyad will participate in this study for just over 1 year. Both conditions will receive three bi-weekly live intervention sessions (30 minutes per session) with an interventionist, and quarterly boosters via text or email.
Enrollment
After parent-child dyads complete screening and informed consent/assent procedures, participants will be invited to complete an online baseline assessment. Following the baseline assessment, dyads will be randomized to receive either the FLARE intervention or standard education. After randomization, each dyad will receive a unique log-in to a secure study website that will be used to review didactic materials prior to each intervention session.
Intervention Sessions
Dyads will meet with an interventionist via remotely-delivered live session for their three intervention sessions. Intervention sessions will be scheduled every two weeks. After completion of the last remotely-delivered session, all parents will receive quarterly booster messages via text or email.
Study Assessments
Dyads will be asked to complete online assessments after consent is given (baseline) and within the 4 days prior to Session 3. A first post-intervention assessment will occur 4 weeks after the last intervention session is held. A second post-intervention assessment will occur 4 weeks later. The long-term follow-up assessment will take place 1-year post-baseline. Each assessment is expected to take 15-30 minutes. Parents will also receive a brief assessment via text or email (depending on parent preference) at monthly intervals between the second post-assessment and the 1-year post-baseline assessment, and in the summer months immediately following the 1-year post-baseline assessment. All assessments will be completed electronically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLARE Intervention | Experimental | Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors. |
|
| Standard Education | No Intervention | Participants will be randomized to receive information on child sun protection that is publicly available. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLARE Intervention | Behavioral | [See arm/group descriptions] |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey | We will measure the mean/standard deviation of child sunburn occurrence at all timepoints. "In the past month, how many times did your child have a red OR painful sunburn that lasted a day or more?" Minimum value = 0; Maximum value = 5 or more; Lower scores indicate a better outcome. | Baseline Assessment (Wk 0) Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette | Mean/Standard deviation of skin tone at all timepoints. Minimum value = 1; Maximum value = 11; Higher score indicates darker skin tone. | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
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Inclusion Criteria:
Adults are eligible for this trial if they:
Children are eligible to participate with their parent if they:
Exclusion Criteria:
Adults and children will be excluded from participation if they meet any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Yelena Wu, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41067748 | Derived | Wu YP, Stump TK, Deboeck PR, Hay JL, Aspinwall LG, Boucher KM, Grossman D, Mooney K, Leachman SA, Smith KR, Brady HL, Hancock SE, Wankier AP, Tercyak KP. Sun protection, sunburn, tanning, and family factors among melanoma survivors and their minor children. J Health Psychol. 2026 May;31(6):2241-2256. doi: 10.1177/13591053251378226. Epub 2025 Oct 9. |
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Parent and child participants received a baseline questionnaire after enrolling but prior to randomization. Because of this, the number at the start of the participant flow differs from the enrollment number since only the randomized participants were included in participant flow. In order to be randomized, the parent needed to complete the questionnaire, and those who did not complete it were not randomized. Child completion of questionnaire was not required for randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | FLARE Intervention Parent | Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors. Intervention parent. |
| FG001 | FLARE Intervention Child | Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors. Intervention child. |
| FG002 | Standard Education Parent | Participants will be randomized to receive information on child sun protection that is publicly available. Control parent. |
| FG003 | Standard Education Child | Participants will be randomized to receive information on child sun protection that is publicly available. Control child. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention |
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| ||||||||||||||||||||||||||||||
| Follow Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FLARE Intervention Parent | Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors. Intervention parent. |
| BG001 | FLARE Intervention Child |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey | We will measure the mean/standard deviation of child sunburn occurrence at all timepoints. "In the past month, how many times did your child have a red OR painful sunburn that lasted a day or more?" Minimum value = 0; Maximum value = 5 or more; Lower scores indicate a better outcome. | The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 2 - Mid-Intervention Assmt 1 - Post Assmt 1
| Posted | Mean | Standard Deviation | score on a scale | Baseline Assessment (Wk 0) Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
|
Adverse Event and Serious Adverse Event data were not collected for this study.
All-Cause Mortality data was not collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FLARE Intervention | Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yelena Wu | Huntsman Cancer Institute at University of Utah | 801-213-5653 | Yelena.Wu@hci.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2026 | May 18, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2022 | May 18, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey | Mean/standard deviation of sunscreen application occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you use sunscreen with an SPF of 30+?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
| Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey | Mean/standard deviation of sunscreen re-application occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you re-apply sunscreen after being outside for 2 hours, in the water, or sweating?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
| Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey | Mean/standard deviation of long sleeved shirt occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday in the sun for 15 minutes or more. How often did you wear a shirt with long sleeves?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
| Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey | Mean/standard deviation of long pants/skirt occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you wear long pants or a long skirt?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
| Parent Report on Child Shade Use Assessed Via Sun Habits Survey | Mean/standard deviation of shade occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you stay in the shade or under an umbrella?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
| Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey | Mean/standard deviation of avoidance of peak hours at all timepoints. "These next questions ask about what you have done in the past (time frame) if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you avoid being in the sun between 10:00AM-4:00PM?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
| Post-Intervention Survey 1 |
|
| Post-Intervention Survey 2 |
|
| 1 Year Post-Baseline |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors. Intervention child. |
| BG002 | Standard Education Parent | Participants will be randomized to receive information on child sun protection that is publicly available. Control parent. |
| BG003 | Standard Education Child | Participants will be randomized to receive information on child sun protection that is publicly available. Control child. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | FLARE Intervention | Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors. FLARE Intervention: [See arm/group descriptions] |
| OG001 | Standard Education | Participants will be randomized to receive information on child sun protection that is publicly available. |
|
|
| Secondary | Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette | Mean/Standard deviation of skin tone at all timepoints. Minimum value = 1; Maximum value = 11; Higher score indicates darker skin tone. | The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 2 - Baseline 4 - Mid-Intervention Assmt 3 - Post Assmt 1 3 - Post Assmt 2 4 - 1-Year Follow-Up | Posted | Mean | Standard Deviation | score on a scale | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
|
|
|
| Secondary | Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey | Mean/standard deviation of sunscreen application occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you use sunscreen with an SPF of 30+?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome | The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 1 - Mid-Intervention Assmt 1 - Post Assmt 1
| Posted | Mean | Standard Deviation | score on a scale | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
|
|
|
| Secondary | Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey | Mean/standard deviation of sunscreen re-application occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you re-apply sunscreen after being outside for 2 hours, in the water, or sweating?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome | The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 1 - Mid-Intervention Assmt 1 - Post Assmt 1
| Posted | Mean | Standard Deviation | score on a scale | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
|
|
|
| Secondary | Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey | Mean/standard deviation of long sleeved shirt occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday in the sun for 15 minutes or more. How often did you wear a shirt with long sleeves?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome | The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 1 - Mid-Intervention Assmt 1 - Post Assmt 1
| Posted | Mean | Standard Deviation | score on a scale | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
|
|
|
| Secondary | Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey | Mean/standard deviation of long pants/skirt occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you wear long pants or a long skirt?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome | The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 1 - Mid-Intervention Assmt 1 - Post Assmt 1
| Posted | Mean | Standard Deviation | score on a scale | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
|
|
|
| Secondary | Parent Report on Child Shade Use Assessed Via Sun Habits Survey | Mean/standard deviation of shade occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you stay in the shade or under an umbrella?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome | The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 1 - Mid-Intervention Assmt 1 - Post Assmt 1
| Posted | Mean | Standard Deviation | score on a scale | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
|
|
|
| Secondary | Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey | Mean/standard deviation of avoidance of peak hours at all timepoints. "These next questions ask about what you have done in the past (time frame) if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you avoid being in the sun between 10:00AM-4:00PM?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome | The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 1 - Mid-Intervention Assmt 1 - Post Assmt 1
| Posted | Mean | Standard Deviation | score on a scale | Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard Education | Participants will be randomized to receive information on child sun protection that is publicly available. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Mid-Intervention Assessment (Wk 5-6) |
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| Post-Assessment 1 (Wk 8-11) |
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| Post Assessment 2 (Wk 12-15) |
|
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| 1-Year-Follow-Up (Wk 52) |
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| Mid-Intervention Assessment (Wk 5-6) |
|
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| Post-Assessment 1 (Wk 8-11) |
|
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| Post-Assessment 2 (Wk 12-15) |
|
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| 1-Year Follow-Up (Wk 52) |
|
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| Mid-Intervention Assessment (Wk 5-6) |
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| Post-Assessment 1 (Wk 8-11) |
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| Post Assessment 2 (Wk 12-15) |
|
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| 1-Year-Follow-Up (Wk 52) |
|
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| Mid-Intervention Assessment (Wk 5-6) |
|
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| Post-Assessment 1 (Wk 8-11) |
|
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| Post-Assessment 2 (Wk 12-15) |
|
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| 1-Year Follow-Up (Wk 52) |
|
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| Mid-Intervention Assessment (Wk 5-6) |
|
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| Post-Assessment 1 (Wk 8-11) |
|
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| Post-Assessment 2 (Wk 12-15) |
|
|
| 1-Year Follow-Up (Wk 52) |
|
|
| Mid-Intervention Assessment (Wk 5-6) |
|
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| Post-Assessment 1 (Wk 8-11) |
|
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| Post-Assessment 2 (Wk 12-15) |
|
|
| 1-Year Follow-Up (Wk 52) |
|
|
| Mid-Intervention Assessment (Wk 5-6) |
|
|
| Post-Assessment 1 (Wk 8-11 |
|
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| Post-Assessment 2 (Wk 12-15) |
|
|
| 1-Year Follow-Up (Wk 52) |
|
|