Childhood CancerJMC-PHOUNCT07558486
Effect of Nutrition Counseling and Physical Exercise Prescription on Body Composition and Nutritional Status of 5-18 Years Pediatric Cancer Patients on Treatment at Jimma Medical Center Pediatric Hematology and Oncology Unit(JMC-PHOU), Jimma, Ethiopia
A study testing dietary counseling and physical exercise prescription in people with Childhood Cancer, run by Jimma University at 1 site in Ethiopia.
Trial summary
Malnutrition and associated muscle wasting are common health problems among pediatric cancer patients. However, the role of dietary counseling and physical exercise prescription intervention on both nutritional status and muscle health is not well documented in pediatric cancer patients, especially in those from… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- dietary counseling and physical exercise prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteEthiopia
- Study dates
- 25 Feb 2025to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All pediatric cancer patients of both sex and in the age range of 5 -18 years attending JMC
- Pediatric cancer patients who pass medical clerance for physical exercise Pediatric cancer pateitns who consent to participate in the study
Who cannot join
- Pediatric cancer patietnt lessthan five years
- Pediatric cancer patients with metallic device in their body for different treatment purposes like pacemaker, bone fracture support, artificial air way
- Pediatric cancer pateitns with severe medical problem and can't participate in physical exercise
- Pediatric cancer pateitns who/whose family decline the informed assent and consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diet and Physical Exercise Intervention: Quasi Experimental Study
Malnutrition and associated muscle wasting are common health problems among pediatric cancer patients. However, the role of dietary counseling and physical exercise prescription intervention on both nutritional status and muscle health is not well documented in pediatric cancer patients, especially in those from low-and middle-income countries.
This study will use quasi-experimental study design that will apply waiting list control and intervention groups to determine the effect of dietary counseling physical exercise prescription on the nutritional status and muscle wasting/sarcopenia among pediatric cancer patients in the age range of 5-18 years receiving cancer treatment at Jimma Medical Center Pediatric Hematology and Oncology Unit (JMC-PHOU). The study participants will be enrolled prospectively according their clinical visit. The participants will be categorized as intervention and awaiting list control groups. The intervention group received dietary counseling by using healthy eating plate as guide and motivational interview as counseling strategy for three consecutive months. In addition to dietary counseling the intervention group will receive three days per week, two sessions a day and 30 minutes per session aerobic(20 minutes per session) and resistance(10 minutes per session) physical exercise prescription. The waiting list control group will receive the same intervention three months later. The sample size was estimated by considering study power of and clinically significant effect size to 104 total sample sizes (i.e. 52 cases per each group). Data will be analyzed by paired sample t-test using IBM SPSS version 25. Statistical significance will be set at 5% with 95% confidence interval (CI). The study result will be reported in mean ±SD and t(df), p-value.
- Conditions
- Childhood Cancer
- Being tested
- dietary counseling and physical exercise prescription
- Keywords
- Malnutrition, Body composition, sarcopenia, Pediatric/childhood cancer, dietary counseling, physical exercise prescription
- Medical subject headings
- Neoplasms, Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary counseling and physical exercise prescriptionBehavioural
This intervention is a combination of dietary counseling using healthy eating plate as a guide and motivational interviewing as a strategy and physical exercise prescription. To the knowledge of the investigator no such intervention was studied so far among pediatric cancer patients in low-and middle-income countries.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | dietary counseling and physical exercise prescription Receives: Behavioral: dietary counseling and physical exercise prescription |
| Control arm | No intervention | waiting list control group, will recive dietary counseling and physical exercise intervention three months later |
What is being measured
The primary outcome is the main question the study is designed to answer.
change body fat mass(FM) in kilogrames (Kg) by taking the difference of the measurments at the the start and end of intervention
Body fat will be measured using bioelectrical impedance analysis(BIA)
Measured: Three months
Change in fat free mass(FFM) in kilograms (Kg)by taking the difference of the measurments at the the start and end of intervention
Fat free mass will be measured using bioelectrical impedance analysis(BIA)
Measured: three months
Change in hydration staus by measuringby taking the difference of total body, extracelluar and intracellular water in liters(L) at the start and end of intervention
Chnange in body hydration will be mesured using BIA
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start25 Feb 2025
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asfaw Gerbi, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558486
- Sponsor's protocol ID
- Jimma University
- Other IDs
- Jimma University, JUIH/IRB/088/24
- Acronym
- JMC-PHOU
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Physical Exercise Intervention: Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT07558486
- Acronym / sponsor ID
- JMC-PHOU / Jimma University
- Conditions
- Childhood Cancer
- Keywords
- Malnutrition, Body composition, sarcopenia, Pediatric/childhood cancer, dietary counseling, physical exercise prescription
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malnutrition and associated muscle wasting are common health problems among pediatric cancer patients. However, the role of dietary counseling and physical exercise prescription intervention on both nutritional status and muscle health is not well documented in pediatric cancer patients, especially in those from low-and middle-income countries.
This study will use quasi-experimental study design that will apply waiting list control and intervention groups to determine the effect of dietary counseling physical exercise prescription on the nutritional status and muscle wasting/sarcopenia among pediatric cancer patients in the age range of 5-18 years receiving cancer treatment at Jimma Medical Center Pediatric Hematology and Oncology Unit (JMC-PHOU). The study participants will be enrolled prospectively according their clinical visit. The participants will be categorized as intervention and awaiting list control groups. The intervention group received dietary counseling by using healthy eating plate as guide and motivational interview as counseling strategy for three consecutive months. In addition to dietary counseling the intervention group will receive three days per week, two sessions a day and 30 minutes per session aerobic(20 minutes per session) and resistance(10 minutes per session) physical exercise prescription. The waiting list control group will receive the same intervention three months later. The sample size was estimated by considering study power of and clinically significant effect size to 104 total sample sizes (i.e. 52 cases per each group). Data will be analyzed by paired sample t-test using IBM SPSS version 25. Statistical significance will be set at 5% with 95% confidence interval (CI). The study result will be reported in mean ±SD and t(df), p-value.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: dietary counseling and physical exercise prescriptiondietary counseling and physical exercise prescription |
| Control arm | No intervention | –waiting list control group, will recive dietary counseling and physical exercise intervention three months later |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All pediatric cancer patients of both sex and in the age range of 5 -18 years attending JMC
- Pediatric cancer patients who pass medical clerance for physical exercise Pediatric cancer pateitns who consent to participate in the study
Key exclusion criteria (4 listed)
- Pediatric cancer patietnt lessthan five years
- Pediatric cancer patients with metallic device in their body for different treatment purposes like pacemaker, bone fracture support, artificial air way
- Pediatric cancer pateitns with severe medical problem and can't participate in physical exercise
- Pediatric cancer pateitns who/whose family decline the informed assent and consent
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 |
|---|---|---|
| dietary counseling and physical exercise prescriptionThis intervention is a combination of dietary counseling using healthy eating plate as a guide and motivational interviewing as a strategy and physical exercise prescription. To the knowledge of the investigator no such intervention was studied so far among pediatric cancer patients in low-and middle-income countries. | Behavioural | Intervention |
Primary outcome
change body fat mass(FM) in kilogrames (Kg) by taking the difference of the measurments at the the start and end of intervention
Time frame: Three months
Body fat will be measured using bioelectrical impedance analysis(BIA)
Change in fat free mass(FFM) in kilograms (Kg)by taking the difference of the measurments at the the start and end of intervention
Time frame: three months
Fat free mass will be measured using bioelectrical impedance analysis(BIA)
Change in hydration staus by measuringby taking the difference of total body, extracelluar and intracellular water in liters(L) at the start and end of intervention
Time frame: three months
Chnange in body hydration will be mesured using BIA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary counseling and physical exercise prescription in people with Childhood Cancer, run by Jimma University at 1 site in Ethiopia.
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 2 inclusion and 4 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change body fat mass(FM) in kilogrames (Kg) by taking the difference of the measurments at the the start and end of intervention (time frame: Three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026.