ObesityNOURISH-TNCT02815982
Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors
A study testing NOURISH-T in people with Obesity and Cancer, run by University of South Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- What is being tested?
- NOURISH-T
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors (NOURISH-T)
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).
Read the 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.
- Being tested
- NOURISH-T, Enhanced Usual Care
- Medical subject headings
- Obesity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOURISH-TBehavioural
Overweight/obesity family intervention
Enhanced Usual CareBehavioural
Publicly available overweight/obesity materials
| Study group | Role | What they receive |
|---|---|---|
| NOURISH-T | Experimental | The intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework is assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the "identified patient" or overweight child. Receives: Behavioral: NOURISH-T |
| Enhanced Usual Care | Active comparator | Caregivers randomized to the EUC will attend assessment sessions and an initial session moderated by an independent interventionist. The session addresses the role of diet and exercise in pediatric overweight. In addition, EUC caregivers receive nationally available print or web-based brochures on pediatric overweight on 2 occasions during the study so that similar (but not as intensive) information is provided in the intervention and EUC arms of the study. Participants also receive a booster phone call 2 months after the end of the intervention period. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (9)
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.
Measured: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)
Continuous child BMI percentile as a function of gender and age. This measure was obtained via the PCS medical chart.
Measured: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure
This 8-item questionnaire was completed by the pediatric cancer survivor and assessed child intake of sugar sweetened beverages, breakfast and dinner habits, as well as frequency of fast food intake. The sum score represents the total number of sugary beverages consumed and the number of times consuming fast food in the prior week. Higher scores indicate greater consumption of sugary beverages and fast food in the prior week. The sum score could range from 0 and has no upper limit.
Measured: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
This 31-item questionnaire assesses parental approaches to and attitudes about feeding their children. Sub-scales include concerns about child weight, monitoring, restriction, and pressure to eat. The sum score of the Likert items ranged from 31 to 155 with higher scores indicating greater perceived concern, monitoring, restriction and pressure to eat.
Measured: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed
PCS and caregivers were trained to wear a piezoelectric, computer downloadable pedometer consecutively for 7 days prior to the pre- and post- intervention and 4 months post-intervention assessments to assess frequency of daily steps. The scale was measured as the continuous number of daily steps averaged over a week.
Measured: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED
Measured at the clinic via standardized equipment.
Measured: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Parent BMI Score -- CAREGIVER MEASURE
Measured at the clinic via standardized equipment.
Measured: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Parent Waist to Hip Ratio -- CAREGIVER MEASURE
Measured at the clinic via standardized equipment
Measured: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE
PCS and caregivers were trained to wear a piezoelectric, computer downloadable pedometer consecutively for 7 days prior to the pre- and post- intervention and 4 months post-intervention assessments to assess frequency of daily steps. The scale was measured as the continuous number of daily steps averaged over a week.
Measured: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startDec 2013
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Johns Hopkins All Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Marilyn Stern, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815982
- Sponsor's protocol ID
- 5R21CA167259-02
- Acronym
- NOURISH-T
- Status last verified
- Dec 2016
- First submitted
- 16 Jun 2016
- Last updated
- 20 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 25559916Stern M, Bleck J, Ewing LJ, Davila E, Lynn C, Hale G, Mazzeo S. NOURISH-T: Targeting caregivers to improve health behaviors in pediatric cancer survivors with obesity. Pediatr Blood Cancer. 2018 May;65(5):e26941. doi: 10.1002/pbc.26941. Epub 2018 Jan 19.
PubMed 29350459
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Caregivers to Enhance Health Behaviors in Pediatric Cancer Survivors (NOURISH-T)
- ClinicalTrials.gov ID
- NCT02815982
- Acronym / sponsor ID
- NOURISH-T / 5R21CA167259-02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Johns Hopkins All Children's Hospital
- Study start
- Dec 2013 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Posted 20 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOURISH-T | Experimental | Behavioral: NOURISH-TThe intervention aims to increase caregivers' self-efficacy for behavioral change, and facilitate an authoritarian approach to parenting. Behavioral strategies such as self-monitoring, contingency management, and stimulus control are integrated in these sessions. Further, because participatory experiences enhance overall intervention efficacy, these activities are incorporated throughout, including self-assessments, discussions and experiential activities. Homework is assigned between sessions so skills can be practiced. We also focus on the caregivers' relationship with everyone in the family, not just the "identified patient" or overweight child. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareCaregivers 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. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Caregivers
- Mothers and fathers (biologic/adoptive/step parents/legal guardians) of pediatric cancer survivors
- 18 years or older
- Fluent in English
- Pediatric Cancer Survivors
Key exclusion criteria (6 listed)
- Caregivers
- are non-ambulatory
- do not reside with the PCS at least 50% of the time.
- Pediatric cancer survivor
- relapse during the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOURISH-TOverweight/obesity family intervention | Behavioural | NOURISH-T |
| Enhanced Usual CarePublicly available overweight/obesity materials | Behavioural | Enhanced Usual Care |
Primary outcome
Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
Time frame: 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.
9 secondary outcomes
Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE
Time frame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)
Time frame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure
Time frame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE
Time frame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed
Time frame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED
Time frame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Parent BMI Score -- CAREGIVER MEASURE
Time frame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Parent Waist to Hip Ratio -- CAREGIVER MEASURE
Time frame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE
Time frame: Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25559916Stern 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.
- Derived from this study: PubMed 29350459Stern M, Bleck J, Ewing LJ, Davila E, Lynn C, Hale G, Mazzeo S. NOURISH-T: Targeting caregivers to improve health behaviors in pediatric cancer survivors with obesity. Pediatr Blood Cancer. 2018 May;65(5):e26941. doi: 10.1002/pbc.26941. Epub 2018 Jan 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn Stern, PhD principal investigator
University of South Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOURISH-T in people with Obesity and Cancer, run by University of South Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02815982, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.