NOURISH-T: Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors

• Sponsor: University of South Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT02815982
• Collaborator: University of Pittsburgh (Other), Johns Hopkins All Children's Hospital (Other)
• Enrollment: 106
• Locations: 2
• Arms: 2
• Actual Duration (Months): 36
• Patients Per Site: 53
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Obesity; Cancer	Behavioral: NOURISH-T; Behavioral: Enhanced Usual Care	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors (NOURISH-T)
• Actual Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NOURISH-T 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.	Behavioral: NOURISH-T; Overweight/obesity family intervention
Active Comparator: Enhanced Usual Care 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.	Behavioral: Enhanced Usual Care; Publicly available overweight/obesity materials

Outcome Measures

Primary Outcome Measures

1. Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE [6 weeks]

   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.

Secondary Outcome Measures

1. Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE [Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)]

   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.

2. Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS) [Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)]

   Continuous child BMI percentile as a function of gender and age. This measure was obtained via the PCS medical chart.

3. Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure [Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)]

   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.

4. Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE [Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)]

   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.

5. Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed [Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)]

   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.

6. Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED [Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)]

   Measured at the clinic via standardized equipment.

7. Parent BMI Score -- CAREGIVER MEASURE [Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)]

   Measured at the clinic via standardized equipment.

8. Parent Waist to Hip Ratio -- CAREGIVER MEASURE [Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)]

   Measured at the clinic via standardized equipment

9. Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE [Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Caregivers

• Mothers and fathers (biologic/adoptive/step parents/legal guardians) of pediatric cancer survivors

• 18 years or older

• Fluent in English

Pediatric Cancer Survivors

• Diagnosis of cancer

• between 5-13 years of age at study entry

• off active cancer treatment for 6 months to 4 years,

• reside with a participating caregiver

• able to engage in PA tailored to current medical status

• NOT taking medications that affect body weight, e.g., steroids within 6 months of enrollment

• at or above the 85th BMI %ile.

Exclusion Criteria:

Caregivers

• are non-ambulatory

• do not reside with the PCS at least 50% of the time.

Pediatric cancer survivor

• relapse during the intervention

• taken a medication known to affect body weight such as oral steroids or antipsychotic medications within 6 months of enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida	United States	33701
2	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224

Sponsors and Collaborators

• University of South Florida
• University of Pittsburgh
• Johns Hopkins All Children's Hospital

Investigators

• Principal Investigator: Marilyn Stern, PhD, University of South Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT02815982
• Other Study ID Numbers: 5R21CA167259-02
• First Posted: Jun 28, 2016
• Last Update Posted: Sep 20, 2018
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	NOURISH-T - Caregivers	Enhanced Usual Care - Caregivers	NOURISH-T - Pediatric Cancer Survivors (PCS)	Enhanced Usual Care - Pediatric Cancer Survivors (PCS)
Arm/Group Description	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	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	PCS are recruited with their caregivers, but do not participate in the intervention. PCS only complete measures.	PCS are recruited with their caregivers, but do not participate in the intervention (EUC), they only complete measures at each time point.
Period Title: Overall Study
STARTED	27	26	27	26
COMPLETED	27	26	27	26
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	NOURISH-T - Caregivers	NOURISH-T - Pediatric Cancer Survivors (PCS)	Enhanced Usual Care - Caregivers	Enhanced Usual Care - Pediatric Cancer Survivors (PCS)	Total
Arm/Group Description	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	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	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	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	Total of all reporting groups
Overall Participants	27	27	26	26	106
Age (Count of Participants)
<=18 years	0 0%	27 100%	0 0%	26 100%	53 50%
Between 18 and 65 years	27 100%	0 0%	26 100%	0 0%	53 50%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
all Participants	38.0 (8.4)	9.48 (2.8)	41.5 (9.2)	10.48 (2.79)	24.87 (5.80)
Sex: Female, Male (Count of Participants)
Female	21 77.8%	13 48.1%	19 73.1%	15 57.7%	68 64.2%
Male	6 22.2%	14 51.9%	7 26.9%	11 42.3%	38 35.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 14.8%	4 14.8%	4 15.4%	4 15.4%	16 15.1%
Not Hispanic or Latino	20 74.1%	20 74.1%	17 65.4%	17 65.4%	74 69.8%
Unknown or Not Reported	3 11.1%	3 11.1%	5 19.2%	5 19.2%	16 15.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	1 3.8%	1 3.8%	2 1.9%
Black or African American	1 3.7%	1 3.7%	0 0%	0 0%	2 1.9%
White	20 74.1%	20 74.1%	17 65.4%	17 65.4%	74 69.8%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	6 22.2%	6 22.2%	8 30.8%	8 30.8%	28 26.4%
Region of Enrollment (participants) [Number]
United States	27 100%	27 100%	26 100%	26 100%	106 100%

Outcome Measures

1. Primary Outcome

Title	Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
Description	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.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Independent Samples T-Test

Arm/Group Title	NOURISH-T	Enhanced Usual Care
Arm/Group Description	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	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
Measure Participants	27	26
Mean (Standard Deviation) [units on a scale]	46.2 (5.1)	37.5 (8.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NOURISH-T, Enhanced Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-8.7
	Confidence Interval	(2-Sided) 95%; -14.6 to -2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE
Description	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.
Time Frame	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NOURISH-T	Enhanced Usual Care (EUC)
Arm/Group Description	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	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. 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
Measure Participants	27	26
Pre-Intervention	1928.9 (628.9)	1802.0 (641.3)
Post-Intervention (6-weeks)	1830.8 (818.7)	1866.4 (732.6)
Follow-up (4 Months)	1732.6 (798.9)	2012.2 (712.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NOURISH-T, Enhanced Usual Care
	Comments	We compared Post-intervention scores
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	p value was the actual signficance level
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	35.6
	Confidence Interval	(2-Sided) 95%; -559.0 to 630.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)
Description	Continuous child BMI percentile as a function of gender and age. This measure was obtained via the PCS medical chart.
Time Frame	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NOURISH-T	Enhanced Usual Care
Arm/Group Description	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	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. 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
Measure Participants	27	26
Pre-Intervention	95.3 (3.9)	95.9 (4.1)
Post-Intervention (6-weeks)	95.2 (3.9)	95.7 (4.7)
Follow-up (4 Months)	94.8 (3.2)	93.4 (5.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NOURISH-T, Enhanced Usual Care
	Comments	We compared Post-intervention BMI
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	controlling for caregiver BMI at baseline and PCS BMI percentile at baseline
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.47
	Confidence Interval	(2-Sided) 95%; -2.3 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure
Description	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.
Time Frame	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NOURISH-T	Enhanced Usual Care(EUC)
Arm/Group Description	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	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. 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
Measure Participants	27	26
Pre-Intervention	9.4 (7.3)	9.5 (7.4)
Post-Intervention (6-weeks)	7.8 (5.0)	7.7 (7.5)
Follow-up (4 Months)	5.1 (4.4)	7.3 (3.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NOURISH-T, Enhanced Usual Care
	Comments	We compared Post-intervention scores
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.03
	Comments	p < .05 was the threshold
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-.12
	Confidence Interval	(2-Sided) 95%; -5.4 to 5.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
Description	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.
Time Frame	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NOURISH-T	Enhanced Usual Care(EUC)
Arm/Group Description	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	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. 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
Measure Participants	27	26
Pre-Intervention	97.3 (15.2)	96.7 (13.6)
Post-Intervention (6-weeks)	95 (10.9)	98.5 (10.2)
Follow-up (4 Months)	95.2 (11.5)	92.3 (7.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NOURISH-T, Enhanced Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.09
	Comments	p < .05 was threshold
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.5
	Confidence Interval	(2-Sided) 95%; -4.3 to 11.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed
Description	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.
Time Frame	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NOURISH-T	Enhanced Usual Care(EUC)
Arm/Group Description	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	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. 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
Measure Participants	27	26
Pre-Intervention	5695.5 (2448.5)	6568.4 (2238.9)
Post-Intervention (6-weeks)	6279.4 (3582.9)	5950.8 (2502.2)
Follow-up (4 Months)	7162.6 (2123.7)	8674.7 (3143.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NOURISH-T, Enhanced Usual Care
	Comments	We compared Post-intervention scores
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.08
	Comments	p < .05 threshold,
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-328.6
	Confidence Interval	(2-Sided) 95%; -2868.4 to 2211.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED
Description	Measured at the clinic via standardized equipment.
Time Frame	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NOURISH-T	Enhanced Usual Care
Arm/Group Description	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	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. 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
Measure Participants	27	26
Pre-Intervention	.94 (.1)	.97 (.1)
Post-Intervention (6-weeks)	.93 (.05)	.98 (.08)
Follow-up (4 Months)	.92 (.09)	.99 (.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NOURISH-T, Enhanced Usual Care
	Comments	We compared Post-intervention scores
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments	threshold set at p < .05
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.06
	Confidence Interval	(2-Sided) 95%; .01 to .11
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Parent BMI Score -- CAREGIVER MEASURE
Description	Measured at the clinic via standardized equipment.
Time Frame	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NOURISH-T	Enhanced Usual Care
Arm/Group Description	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	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. 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
Measure Participants	27	26
Pre-Intervention	32.9 (12.2)	32.1 (6.4)
Post-Intervention (6-weeks)	33.2 (13.5)	30.3 (6.6)
Follow-up (4 Months)	32.4 (9.5)	32.5 (8.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NOURISH-T, Enhanced Usual Care
	Comments	We compared Post-intervention scores
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	threshold set at p < .05
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.85
	Confidence Interval	(2-Sided) 95%; -11.3 to 5.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Parent Waist to Hip Ratio -- CAREGIVER MEASURE
Description	Measured at the clinic via standardized equipment
Time Frame	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NOURISH-T	Enhanced Usual Care (EUC)
Arm/Group Description	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	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. 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
Measure Participants	27	26
Pre-Intervention	.94 (.06)	.91 (.09)
Post-Intervention (6-weeks)	.90 (.06)	.91 (.06)
Follow-up (4 Months)	.90 (.05)	.94 (.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NOURISH-T, Enhanced Usual Care
	Comments	We compared Post-intervention scores
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	threshold p < .05
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.01
	Confidence Interval	(2-Sided) 95%; -.04 to .06
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE
Description	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.
Time Frame	Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NOURISH-T	Enhanced Usual Care
Arm/Group Description	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	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. 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
Measure Participants	27	26
Pre-Interve'ntion	7016.7 (2928.3)	6288.3 (2923.2)
Post-Intervention (6-weeks)	5439.0 (3441.7)	5090.1 (1893.8)
Follow-up (4 Months)	7087.4 (4506.1)	5891.2 (2205.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NOURISH-T, Enhanced Usual Care
	Comments	We compared Post-intervention scores
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.12
	Comments	p < .05 was the threshold
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-348.9
	Confidence Interval	(2-Sided) 95%; -2762.5 to 2064.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	2 years monitored for both the caregivers and for the pediatric cancer survivors (PCS); none identified
Arm/Group Title	NOURISH-T - Caregivers		Enhanced Usual Care - Caregivers		NOURISH-T - Pediatric Cancer Survivors (PCS)		Enhanced Usual Care - Pediatric Cancer Survivors (PCS)
Arm/Group Description	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		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		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		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
All Cause Mortality
	NOURISH-T - Caregivers		Enhanced Usual Care - Caregivers		NOURISH-T - Pediatric Cancer Survivors (PCS)		Enhanced Usual Care - Pediatric Cancer Survivors (PCS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	NOURISH-T - Caregivers		Enhanced Usual Care - Caregivers		NOURISH-T - Pediatric Cancer Survivors (PCS)		Enhanced Usual Care - Pediatric Cancer Survivors (PCS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/26 (0%)		0/27 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	NOURISH-T - Caregivers		Enhanced Usual Care - Caregivers		NOURISH-T - Pediatric Cancer Survivors (PCS)		Enhanced Usual Care - Pediatric Cancer Survivors (PCS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/26 (0%)		0/27 (0%)		0/26 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.