Trial Outcomes & Findings for Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors (NCT NCT02815982)
NCT ID: NCT02815982
Last Updated: 2018-09-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
6 weeks
Results posted on
2018-09-20
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
NOURISH-T - Pediatric Cancer Survivors (PCS)
PCS are recruited with their caregivers, but do not participate in the intervention. PCS only complete measures.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
27
|
26
|
|
Overall Study
COMPLETED
|
27
|
26
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors
Baseline characteristics by cohort
| Measure |
NOURISH-T - Caregivers
n=27 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 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
|
NOURISH-T - Pediatric Cancer Survivors (PCS)
n=27 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 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
|
Enhanced Usual Care - Caregivers
n=26 Participants
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
|
Enhanced Usual Care - Pediatric Cancer Survivors (PCS)
n=26 Participants
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
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
all Participants
|
38.0 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
9.48 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
10.48 years
STANDARD_DEVIATION 2.79 • n=4 Participants
|
24.87 years
STANDARD_DEVIATION 5.80 • n=21 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
26 participants
n=5 Participants
|
26 participants
n=4 Participants
|
106 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Independent Samples T-Test
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.
Outcome measures
| Measure |
NOURISH-T
n=27 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
|
Enhanced Usual Care
n=26 Participants
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
|
|---|---|---|
|
Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
|
46.2 units on a scale
Standard Deviation 5.1
|
37.5 units on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
NOURISH-T
n=27 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
|
Enhanced Usual Care
n=26 Participants
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
|
|---|---|---|
|
Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE
Pre-Intervention
|
1928.9 calories
Standard Deviation 628.9
|
1802.0 calories
Standard Deviation 641.3
|
|
Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE
Follow-up (4 Months)
|
1732.6 calories
Standard Deviation 798.9
|
2012.2 calories
Standard Deviation 712.4
|
|
Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE
Post-Intervention (6-weeks)
|
1830.8 calories
Standard Deviation 818.7
|
1866.4 calories
Standard Deviation 732.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
NOURISH-T
n=27 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
|
Enhanced Usual Care
n=26 Participants
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
|
|---|---|---|
|
Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)
Pre-Intervention
|
95.3 percentile
Standard Deviation 3.9
|
95.9 percentile
Standard Deviation 4.1
|
|
Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)
Post-Intervention (6-weeks)
|
95.2 percentile
Standard Deviation 3.9
|
95.7 percentile
Standard Deviation 4.7
|
|
Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)
Follow-up (4 Months)
|
94.8 percentile
Standard Deviation 3.2
|
93.4 percentile
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
NOURISH-T
n=27 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
|
Enhanced Usual Care
n=26 Participants
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
|
|---|---|---|
|
Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure
Follow-up (4 Months)
|
5.1 units on a scale
Standard Deviation 4.4
|
7.3 units on a scale
Standard Deviation 3.3
|
|
Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure
Pre-Intervention
|
9.4 units on a scale
Standard Deviation 7.3
|
9.5 units on a scale
Standard Deviation 7.4
|
|
Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure
Post-Intervention (6-weeks)
|
7.8 units on a scale
Standard Deviation 5.0
|
7.7 units on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
NOURISH-T
n=27 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
|
Enhanced Usual Care
n=26 Participants
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
|
|---|---|---|
|
Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
Pre-Intervention
|
97.3 units on a scale
Standard Deviation 15.2
|
96.7 units on a scale
Standard Deviation 13.6
|
|
Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
Post-Intervention (6-weeks)
|
95 units on a scale
Standard Deviation 10.9
|
98.5 units on a scale
Standard Deviation 10.2
|
|
Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
Follow-up (4 Months)
|
95.2 units on a scale
Standard Deviation 11.5
|
92.3 units on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
NOURISH-T
n=27 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
|
Enhanced Usual Care
n=26 Participants
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
|
|---|---|---|
|
Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed
Pre-Intervention
|
5695.5 Average number of steps per day
Standard Deviation 2448.5
|
6568.4 Average number of steps per day
Standard Deviation 2238.9
|
|
Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed
Post-Intervention (6-weeks)
|
6279.4 Average number of steps per day
Standard Deviation 3582.9
|
5950.8 Average number of steps per day
Standard Deviation 2502.2
|
|
Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed
Follow-up (4 Months)
|
7162.6 Average number of steps per day
Standard Deviation 2123.7
|
8674.7 Average number of steps per day
Standard Deviation 3143.9
|
SECONDARY outcome
Timeframe: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)Measured at the clinic via standardized equipment.
Outcome measures
| Measure |
NOURISH-T
n=27 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
|
Enhanced Usual Care
n=26 Participants
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
|
|---|---|---|
|
Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED
Pre-Intervention
|
.94 ratio
Standard Deviation .1
|
.97 ratio
Standard Deviation .1
|
|
Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED
Post-Intervention (6-weeks)
|
.93 ratio
Standard Deviation .05
|
.98 ratio
Standard Deviation .08
|
|
Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED
Follow-up (4 Months)
|
.92 ratio
Standard Deviation .09
|
.99 ratio
Standard Deviation .08
|
SECONDARY outcome
Timeframe: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)Measured at the clinic via standardized equipment.
Outcome measures
| Measure |
NOURISH-T
n=27 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
|
Enhanced Usual Care
n=26 Participants
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
|
|---|---|---|
|
Parent BMI Score -- CAREGIVER MEASURE
Pre-Intervention
|
32.9 kg/m^2
Standard Deviation 12.2
|
32.1 kg/m^2
Standard Deviation 6.4
|
|
Parent BMI Score -- CAREGIVER MEASURE
Post-Intervention (6-weeks)
|
33.2 kg/m^2
Standard Deviation 13.5
|
30.3 kg/m^2
Standard Deviation 6.6
|
|
Parent BMI Score -- CAREGIVER MEASURE
Follow-up (4 Months)
|
32.4 kg/m^2
Standard Deviation 9.5
|
32.5 kg/m^2
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)Measured at the clinic via standardized equipment
Outcome measures
| Measure |
NOURISH-T
n=27 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
|
Enhanced Usual Care
n=26 Participants
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
|
|---|---|---|
|
Parent Waist to Hip Ratio -- CAREGIVER MEASURE
Pre-Intervention
|
.94 ratio
Standard Deviation .06
|
.91 ratio
Standard Deviation .09
|
|
Parent Waist to Hip Ratio -- CAREGIVER MEASURE
Post-Intervention (6-weeks)
|
.90 ratio
Standard Deviation .06
|
.91 ratio
Standard Deviation .06
|
|
Parent Waist to Hip Ratio -- CAREGIVER MEASURE
Follow-up (4 Months)
|
.90 ratio
Standard Deviation .05
|
.94 ratio
Standard Deviation .07
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
NOURISH-T
n=27 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
|
Enhanced Usual Care
n=26 Participants
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
|
|---|---|---|
|
Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE
Pre-Interve'ntion
|
7016.7 Average number of steps per day
Standard Deviation 2928.3
|
6288.3 Average number of steps per day
Standard Deviation 2923.2
|
|
Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE
Post-Intervention (6-weeks)
|
5439.0 Average number of steps per day
Standard Deviation 3441.7
|
5090.1 Average number of steps per day
Standard Deviation 1893.8
|
|
Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE
Follow-up (4 Months)
|
7087.4 Average number of steps per day
Standard Deviation 4506.1
|
5891.2 Average number of steps per day
Standard Deviation 2205.2
|
Adverse Events
NOURISH-T - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NOURISH-T - Pediatric Cancer Survivors (PCS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care - Pediatric Cancer Survivors (PCS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place