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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| Johns Hopkins All Children's Hospital | OTHER |
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This purpose of this pilot study is to investigate the feasibility of and optimal time post cancer treatment to offer caregivers a new health behavior change intervention (NOURISH-T), as well as assess its preliminary efficacy on specific child health behaviors. The study will also explore whether caregivers NOURISH-T exhibit more improvements than caregivers in EUC (standard care).
Approximately 40% of off-treatment pediatric cancer survivors (PCS) are overweight or obese, which increases their risk for negative long-term physical health complications. Consistent with the Institute of Medicine's (IOM) emphasis on patients transitioning from treatment to cancer survivorship and increasing long-term healthy behaviors in these survivors, we conducted a pilot RCT to address the increasing overweight/obesity rates among PCS by targeting their caregivers as agents for PCS behavior change. We focused on parents' behaviors, attitudes and roles in promoting healthier eating and physical activity (PA) in PCS and adapted an evidence-informed, manualized parent intervention - NOURISH - found to be effective for parents of overweight and obese children and adolescents in reducing child and adolescent BMI. We adapted NOURISH for caregivers of 5 - 13 year old PCS (6 months -4 years off active cancer treatment). Our pilot feasibility RCT - NOURISH-T (Nourishing Our Understanding of Role modeling to Improve Support for Healthy Transitions) evaluates: 1) the preliminary feasibility efficacy of NOURISH-T for PCS, compared with an Enhanced Usual Care (EUC) control condition, and 2) factors to consider to improve future adaptations of the intervention. The project enrolled caregivers of PCS at two pediatric oncology clinics into the 6-week intervention (or EUC) with assessments of both caregivers and PCS occurring pre- and post-6 weeks of intervention, and at a 4-month follow-up. In comparison to EUC, we hypothesized that caregivers and PCS assigned to the NOURISH-T condition would show greater improvements in dietary intake, physical activity, and in anthropometric health indicators over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOURISH-T | Experimental | The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework is assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the "identified patient" or overweight child. |
|
| Enhanced Usual Care | Active Comparator | Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session addresses the role of diet and exercise in pediatric overweight. In addition, EUC caregivers receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants also receive a booster phone call 2 months after the end of the intervention period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOURISH-T | Behavioral | Overweight/obesity family intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE | At the end of the final session (6-sessions), caregivers completed a likert-type survey assessing what they liked/disliked about the intervention, as well as what was/was not useful or helpful in reaching health goals. Eleven items were summed to obtain a total continuous composite satisfaction/liking score. Each item was measured on a likert scale ranging from strongly disagree (=1) to strongly agree (=5). The scale sum score ranged from 11 to 55 with higher scores indicating greater satisfaction with the intervention. More specifically, the higher the score, the more useful the caregiver thought the intervention and the more they liked participating in the intervention. Lower scores indicate that the caregiver thought the program was not useful and they did not like participating. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE | A 24-hour recall was completed by caregivers using the Automated Self-administered 24-Hour Dietary Recall-2011 (adult version) at pre-intervention, post-intervention (6-weeks) and at 4 months follow-up. The outcome was measured as the number of calories consumed over 1-day. Caregivers reported detailed information on the foods consumed and quantity including the method used for preparation, portion sizes, and where the food was purchased using visual cues in the previous day through the ASA24 website (https://asa24.nci.nih.gov/). The website reported the total number of calories consumed based on the data input. |
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Inclusion Criteria:
Caregivers
Pediatric Cancer Survivors
Exclusion Criteria:
Caregivers
Pediatric cancer survivor
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| Name | Affiliation | Role |
|---|---|---|
| Marilyn Stern, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States | ||
| Children's Hospital of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25559916 | Background | Stern M, Ewing L, Davila E, Thompson AL, Hale G, Mazzeo S. Design and rationale for NOURISH-T: a randomized control trial targeting parents of overweight children off cancer treatment. Contemp Clin Trials. 2015 Mar;41:227-37. doi: 10.1016/j.cct.2014.12.018. Epub 2015 Jan 2. | |
| 29350459 | Derived | Stern M, Bleck J, Ewing LJ, Davila E, Lynn C, Hale G, Mazzeo S. NOURISH-T: Targeting caregivers to improve health behaviors in pediatric cancer survivors with obesity. Pediatr Blood Cancer. 2018 May;65(5):e26941. doi: 10.1002/pbc.26941. Epub 2018 Jan 19. |
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Caregivers and PCS were recruited as dyads, however, caregivers participated in the intervention (NOURISH-T vs EUC) and completed measures. PCS did not participate in the intervention and only completed measures. Outcomes are noted by whether caregivers or PCS completed measures.
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| ID | Title | Description |
|---|---|---|
| FG000 | NOURISH-T - Caregivers | Participants consisted of caregivers of obese pediatric cancer survivors (PCS). PCS are assessed at each time point (baseline, post intervention and 4 months follow-up), but do not directly participate in the intervention. NOURISH-T intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework is assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the "identified patient" or overweight child. Different measures are administered to caregivers and PCS. NOURISH-T: Overweight/obesity family intervention |
| FG001 | Enhanced Usual Care - Caregivers | Participants consisted of caregivers of obese pediatric cancer survivors (PCS). PCS are assessed but do not directly participate in the EUC group. randomized to the EUC attend assessment sessions and an initial session moderated by an independent interventionist. The session addresses the role of diet and exercise in pediatric overweight. In addition, EUC caregivers receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants also receive a booster phone call 2 months after the end of the intervention period. Different measures are administered to caregivers and PCS. Enhanced Usual Care: Publicly available overweight/obesity materials |
| FG002 | NOURISH-T - Pediatric Cancer Survivors (PCS) | PCS are recruited with their caregivers, but do not participate in the intervention. PCS only complete measures. |
| FG003 | Enhanced Usual Care - Pediatric Cancer Survivors (PCS) | PCS are recruited with their caregivers, but do not participate in the intervention (EUC), they only complete measures at each time point. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We recruited caregivers as a function of their child's characteristics (e.g., PCS eligibility criteria of age, BMI percentile, time off active treatment)
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| ID | Title | Description |
|---|---|---|
| BG000 | NOURISH-T - Caregivers | The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework will be assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the "identified patient" or overweight child. NOURISH-T: Overweight/obesity family intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE | At the end of the final session (6-sessions), caregivers completed a likert-type survey assessing what they liked/disliked about the intervention, as well as what was/was not useful or helpful in reaching health goals. Eleven items were summed to obtain a total continuous composite satisfaction/liking score. Each item was measured on a likert scale ranging from strongly disagree (=1) to strongly agree (=5). The scale sum score ranged from 11 to 55 with higher scores indicating greater satisfaction with the intervention. More specifically, the higher the score, the more useful the caregiver thought the intervention and the more they liked participating in the intervention. Lower scores indicate that the caregiver thought the program was not useful and they did not like participating. | Independent Samples T-Test | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
2 years monitored for both the caregivers and for the pediatric cancer survivors (PCS); none identified
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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 | NOURISH-T - Caregivers | The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework will be assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the "identified patient" or overweight child. NOURISH-T: Overweight/obesity family intervention |
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Self-report nature of the measures; Measurement error associated with the use of the pedometers; Differences in protocol between sites impacted sample size. Dyads were recruited, different measures were administered to caregivers and PCS.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marilyn Stern | University of South Florida | 8139740966 | mstern1@usf.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Enhanced Usual Care |
| Behavioral |
Publicly available overweight/obesity materials |
|
| Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
| Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS) | Continuous child BMI percentile as a function of gender and age. This measure was obtained via the PCS medical chart. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
| Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure | This 8-item questionnaire was completed by the pediatric cancer survivor and assessed child intake of sugar sweetened beverages, breakfast and dinner habits, as well as frequency of fast food intake. The sum score represents the total number of sugary beverages consumed and the number of times consuming fast food in the prior week. Higher scores indicate greater consumption of sugary beverages and fast food in the prior week. The sum score could range from 0 and has no upper limit. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
| Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE | This 31-item questionnaire assesses parental approaches to and attitudes about feeding their children. Sub-scales include concerns about child weight, monitoring, restriction, and pressure to eat. The sum score of the Likert items ranged from 31 to 155 with higher scores indicating greater perceived concern, monitoring, restriction and pressure to eat. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
| Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed | PCS and caregivers were trained to wear a piezoelectric, computer downloadable pedometer consecutively for 7 days prior to the pre- and post- intervention and 4 months post-intervention assessments to assess frequency of daily steps. The scale was measured as the continuous number of daily steps averaged over a week. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
| Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED | Measured at the clinic via standardized equipment. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
| Parent BMI Score -- CAREGIVER MEASURE | Measured at the clinic via standardized equipment. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
| Parent Waist to Hip Ratio -- CAREGIVER MEASURE | Measured at the clinic via standardized equipment | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
| Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE | PCS and caregivers were trained to wear a piezoelectric, computer downloadable pedometer consecutively for 7 days prior to the pre- and post- intervention and 4 months post-intervention assessments to assess frequency of daily steps. The scale was measured as the continuous number of daily steps averaged over a week. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
| Pittsburgh |
| Pennsylvania |
| 15224 |
| United States |
| BG001 | NOURISH-T - Pediatric Cancer Survivors (PCS) | The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework will be assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the "identified patient" or overweight child. NOURISH-T: Overweight/obesity family intervention |
| BG002 | Enhanced Usual Care - Caregivers | Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period. Enhanced Usual Care: Publicly available overweight/obesity materials |
| BG003 | Enhanced Usual Care - Pediatric Cancer Survivors (PCS) | Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period. Enhanced Usual Care: Publicly available overweight/obesity materials |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework is assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the "identified patient" or overweight child. PCS are assessed, but do not directly participate in the intervention. NOURISH-T: Overweight/obesity family intervention |
| OG001 | Enhanced Usual Care | Caregivers randomized to the enhanced usual care will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Caregivers also receive a booster phone call 2 months after the end of the intervention period. PCS are assessed, but do not directly participate in the intervention. Enhanced Usual Care: Publicly available overweight/obesity materials |
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| Secondary | Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE | A 24-hour recall was completed by caregivers using the Automated Self-administered 24-Hour Dietary Recall-2011 (adult version) at pre-intervention, post-intervention (6-weeks) and at 4 months follow-up. The outcome was measured as the number of calories consumed over 1-day. Caregivers reported detailed information on the foods consumed and quantity including the method used for preparation, portion sizes, and where the food was purchased using visual cues in the previous day through the ASA24 website (https://asa24.nci.nih.gov/). The website reported the total number of calories consumed based on the data input. | Posted | Mean | Standard Deviation | calories | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
|
|
|
|
| Secondary | Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS) | Continuous child BMI percentile as a function of gender and age. This measure was obtained via the PCS medical chart. | Posted | Mean | Standard Deviation | percentile | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
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| Secondary | Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure | This 8-item questionnaire was completed by the pediatric cancer survivor and assessed child intake of sugar sweetened beverages, breakfast and dinner habits, as well as frequency of fast food intake. The sum score represents the total number of sugary beverages consumed and the number of times consuming fast food in the prior week. Higher scores indicate greater consumption of sugary beverages and fast food in the prior week. The sum score could range from 0 and has no upper limit. | Posted | Mean | Standard Deviation | units on a scale | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
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| Secondary | Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE | This 31-item questionnaire assesses parental approaches to and attitudes about feeding their children. Sub-scales include concerns about child weight, monitoring, restriction, and pressure to eat. The sum score of the Likert items ranged from 31 to 155 with higher scores indicating greater perceived concern, monitoring, restriction and pressure to eat. | Posted | Mean | Standard Deviation | units on a scale | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
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| Secondary | Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed | PCS and caregivers were trained to wear a piezoelectric, computer downloadable pedometer consecutively for 7 days prior to the pre- and post- intervention and 4 months post-intervention assessments to assess frequency of daily steps. The scale was measured as the continuous number of daily steps averaged over a week. | Posted | Mean | Standard Deviation | Average number of steps per day | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
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| Secondary | Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED | Measured at the clinic via standardized equipment. | Posted | Mean | Standard Deviation | ratio | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
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| Secondary | Parent BMI Score -- CAREGIVER MEASURE | Measured at the clinic via standardized equipment. | Posted | Mean | Standard Deviation | kg/m^2 | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
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| Secondary | Parent Waist to Hip Ratio -- CAREGIVER MEASURE | Measured at the clinic via standardized equipment | Posted | Mean | Standard Deviation | ratio | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
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| Secondary | Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE | PCS and caregivers were trained to wear a piezoelectric, computer downloadable pedometer consecutively for 7 days prior to the pre- and post- intervention and 4 months post-intervention assessments to assess frequency of daily steps. The scale was measured as the continuous number of daily steps averaged over a week. | Posted | Mean | Standard Deviation | Average number of steps per day | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
|
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|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Enhanced Usual Care - Caregivers | Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period. Enhanced Usual Care: Publicly available overweight/obesity materials | 0 | 26 | 0 | 26 |
| EG002 | NOURISH-T - Pediatric Cancer Survivors (PCS) | The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework will be assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the "identified patient" or overweight child. NOURISH-T: Overweight/obesity family intervention | 0 | 27 | 0 | 27 |
| EG003 | Enhanced Usual Care - Pediatric Cancer Survivors (PCS) | Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session will address the role of diet and exercise in pediatric overweight. In addition, EUC caregivers will receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants will also receive a booster phone call 2 months after the end of the intervention period. Enhanced Usual Care: Publicly available overweight/obesity materials | 0 | 26 | 0 | 26 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Follow-up (4 Months) |
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| Follow-up (4 Months) |
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| Follow-up (4 Months) |
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| Follow-up (4 Months) |
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| Follow-up (4 Months) |
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| Follow-up (4 Months) |
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| Follow-up (4 Months) |
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| Follow-up (4 Months) |
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| Follow-up (4 Months) |
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