Obesity Clinical Trial
— NOURISH-TOfficial title:
Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors (NOURISH-T)
Verified date | December 2016 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 106 |
Est. completion date | December 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 13 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | Johns Hopkins All Children's Hospital, University of Pittsburgh |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 6 weeks | |
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. | 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. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) | |
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. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) | |
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. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) | |
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. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) | |
Secondary | 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) | |
Secondary | Parent BMI Score -- CAREGIVER MEASURE | Measured at the clinic via standardized equipment. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) | |
Secondary | Parent Waist to Hip Ratio -- CAREGIVER MEASURE | Measured at the clinic via standardized equipment | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) | |
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. | Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months) |
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