Obesity Prevention in Children and Young People Treated for Acute Lymphoblastic Leukaemia with ALLTogether

NCT06846294 | Not Yet Recruiting DMC

• 1 other identifier: BREVARY_Mad_Exe
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 2

Brief Summary

Background Leukaemia is the most common cancer in children with 800 diagnoses per year in England. To survive, children need strong treatments like chemotherapy and steroids given usually through clinical trials. The current trial used by the NHS is called ALLTogether. Fifty percent of children become obese during treatment due to increased hunger, cravings for junk foods and lack of physical activity. Obesity raises the chance of cancer relapse by 31%, makes treatment side-effects worse and makes it harder to kill off leukaemia cells, which affects how well children do during treatment, as indicated by minimal residual disease, a key predictor of prognosis. Aims and Objectives This study (called BREVARY) aims to see if we can successfully provide personalised diet and physical activity with behaviour support for children and young people with leukaemia who are being treated with the ALLTogether trial. It will help us figure out if we can perform a bigger study, if this programme could reduce obesity and side-effects and improve survival and wellbeing. How it will be done We plan to randomly assign participants to one of three groups; one group will get both a diet and physical activity plan, another will get only a diet plan, and the last group will receive standard care. This will take place in Hospital Infantil Universitario Nino Jesus, Madrid and Bristol Royal Hospital for Children and Southwest England NHS-sites. The diet and exercise plans will be created in partnership with the children and their families and delivered online or during regular hospital visits. The diet will follow healthy eating guidelines, consider personal food preferences (including cultural and religious needs), treatment side-effects and personal finances. Assessments of fitness and strength will be taken to plan personalised activities. During the study, the following data will also be collected: weight, height, body fat, diet, biomarkers, microbiome, muscle strength and wellbeing at three different times. "One to one" interviews will be conducted at the end to obtain feedback on their experiences with BREVARY. This study aims to find out if children and their families/carers are willing to participate in BREVARY, if enough people sign up and stay until the end and if our interventions and health measurements are appropriate. Potential Impact The results will help determine if a larger study can be performed, if changes are needed and what the cost will be. The study will be disseminated through networks, targeting underserved communities, healthcare professionals and affected families using accessible platforms to spread the word.

Conditions

Diet Intervention; Physical Activity Intervention; Standard Care Control

Keywords

Diet; Physical Activity; Obesity; Acute Lymphoblastic Leukaemia; Children and Young People; ALLTogether

Outcome Measures

Primary Outcomes (15)

• Minimal Residual Disease

  Candidate Primary Outcome (feasibility study). Hospital own's laboratory assay

  initial assessment, day 29, day 50 and day 78

• Muscle and fat mass

  Candidate primary outcome, Multifrequency BIA FFM and FM percentage Impedance Reactant

  Initial assessment, at 29 days, at 3 months, at 6 months

• Body Mass Index Z score

  Candidate Primary Outcome Calculated from weight and height (weight/height\^2) WHO BMI Z score (scale score) Z-Score Range Nutritional Status \< -3 SD: Severe undernutrition (Severely underweight, stunted, or wasted) * -3 SD and \< -2 SD: Moderate undernutrition (Underweight, stunted, or wasted) * -2 SD and ≤ +1 SD: Healthy weight (Normal nutritional status) * +1 SD and ≤ +2 SD: Overweight * +2 SD: Obese

  initial assessment, at day 29, at 3 months and at 6 months

• Quality of Life

  Candidate Primary outcome (Quality of Life: PedQL-Cancer Module questionnaire) The PedsQL-Cancer Module includes multiple subscales that address specific areas of functioning and challenges related to cancer, such as: Pain and hurt, Nausea, Procedural anxiety, Treatment anxiety, Worry, Cognitive problems, Perceived physical appearance, Communication. To calculate scores, the items are reverse scored and linearly transformed to a Original Response Reverse Score (Transformed Score) 0 = Never 100 1. = Almost Never 75 2. = Sometimes 50 3. = Often 25 4. = Almost Always 0 Scores are reverse, thus higher scores indicate better health-related quality of life or fewer reported problems. Mean scores are calculated for each subscale by summing the item scores and dividing by the number of items answered. If more than 50% of the items in a subscale are missing, the subscale score is not computed.

  initial assessment, at 3 months and at 6 months

• Parent's quality of life

  Parents PedQL-Cancer he PedsQL Cancer Module - Parent Proxy Report is a specialized tool designed to assess health-related quality of life (HRQoL) in children and adolescents with cancer, based on the parent's perception. The Parent PedsQL Cancer Module includes the following subscales tailored to cancer-related challenges: Pain and Hurt, Nausea, Procedural Anxiety, Treatment Anxiety, Worry, Cognitive Problems, Perceived Physical Appearance, Communication To calculate scores, the items are reverse scored and linearly transformed to a 0-100 scale: 0 = 100; 1 = 75; 2 = 50; 3 = 25; 4 = 0 Higher scores indicate better health-related quality of life or fewer reported problems.

  Initial assessment, at 3 months and at 6 months

• Feasibility: Participation rate

  The proportion of the target population that actually participates in the intervention measured in frequencies

  Baseline, time 0

• Feasibility: Representativeness

  The degree to which the participants reflect the broader population intended to benefit from the intervention. Outcome measure in percentages

  At 0, day 29, 3 months and 6 months

• Feasibility: Accessibility

  Evaluates whether the intervention is accessible to all segments of the target population, including those who are typically underrepresented. Outcome measure in percentage

  At 0, day 29, 3 months and 6 months

• Feasibility: Barriers to participation

  Identifies factors that prevent individuals from engaging with the intervention, such as lack of awareness, logistical issues, or cultural barriers. Outcome: qualitative

  At 0, day 29, 3 months and 6 months

• Feasibility: Effectiveness

  The trial will be regarded feasible if the following criteria are met: * Recruitment rate ≥ 50% * ≥ 70% of recruited families complete the trial in one of the intervention groups * ≥ 70% of families, researchers and clinical staff agree that the intervention is acceptable (survey) * Recruited participants complete ≥ 60% of the supervised sessions * ≥ 70% of families agree that the intervention is enjoyable The overall outcome is categorical: Yes, No or yes with conditions/amendments

  At 0, day 29, 3 months and 6 months

• Feasibility: Adoption

  Settings: the proportion of settings that agree to implement the intervention. Outcome measured in percentage.

  At 0, day 29, 3 months and 6 months

• Feasibility: staff/provider adoption

  The proportion and characteristics of researchers and healthcare staff who choose to deliver the intervention. Outcome in percentages

  At 0, day 29, 3 months and 6 months

• Feasibility: Barriers and facilitators: Qualitative

  Identifies factors that help or hinder the willingness of organisations and individuals to adopt the intervention (e.g., cost, training requirements, organisational culture). Outcome: quaitative

  At 0, day 29, 3 months and 6 months

• Feasibility: Fidelity

  Fidelity scores ranging from 0 to 100 (e.g., percentage of protocol elements followed) where 0 is nothing was followed and 100 everything was followed as originally planned.

  At 0, day 29, 3 months and 6 months

• Cost-effectiveness

  Cost-utility analysis to evaluate the economic value of different interventions (or arms) by comparing their costs to their outcomes. This is based on quality-adjusted life in years. QALY will be generated via measurement of utility values using PedsQL-cancer and Parents PedQL-Cancer instrument mapped to the EQ-5D. Outcome: scale in pounds and euros. Total cost of control, cost of diet alone and cost of diet and physical activity

  At 0, 3 months and 6 months

Secondary Outcomes (18)

• Leptin

  Initial assessment, at day 29, at 3 months and at 6 months

• Food group indicators and nutrient intake

  Initial assessment, at day 29, at 3 months and at 6 months

• Physical activity levels min/day

  Initial assessment, at 3 months and at 6 months

• Handgrip strength

  Initial assessment, at day 29, at 3 months and at 6 months

• Fitness

  Initial assessment, at day 29, at 3 months and at 6 months

Other Outcomes (2)

• Characterisation of gut microbiome: Diversity

  At 0, day 29, 3 months and 6 months

• Gut microbiome: Relative abundance

  At 0, day 29, 3 months and 6 months

Study Arms (3)

Diet

EXPERIMENTAL

Individualised Dietary Intervention

Behavioral: Diet

Diet and Physical Activity

EXPERIMENTAL

Individualised Dietary and Physical Activity Intervention

Behavioral: Diet and physical activity

Standard Care

NO INTERVENTION

No intervention - this is standard care

Interventions

Diet BEHAVIORAL

Individualised dietary intervention

Diet

Diet and physical activity BEHAVIORAL

Obesity prevention: Diet, Diet and physical activity and standard care

Diet and Physical Activity

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• CYP aged between 5 - 21 years.
• Newly diagnosed or relapsed CYP\_ALL treated in University Hospital Bristol and Weston NHS Foundation Trust and Hospital Infantil Universitario Nino Jesus, Madrid
• Within two weeks of being recruited to ALLTogether.
• Treated with curative intent.

You may not qualify if:

• CYP not partaking in ALLTogether.
• CYP treated with palliative intent.
• Those excluded by healthcare professionals or clinical reasons

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (2)

Hospital Infantil Universitario Nino Jesus

Madrid, Madrid, 28009, Spain

Location

University Hospitals Bristol & Weston NHS Trust

Bristol, Somerset, BS1 3NU, United Kingdom

Location

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MeSH Terms

Conditions

Motor Activity; Obesity; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Raquel Revuelta Iniesta, PhD

  University of Exeter

  STUDY CHAIR

• Carmen Fiuza Luces, PhD

  Hospital 12 de Octubre Research Institute

  STUDY CHAIR

• Raquel Revuelta Iniesta, PhD

  University of Exeter

  STUDY DIRECTOR

Central Study Contacts

Raquel Revuelta Iniesta, PhD

CONTACT

0044 07715303535; r.revuelta-iniesta@exeter.ac.uk

Raquel Fiuza Luces, PhD

CONTACT

0034 658961509; r.revuelta-iniesta@exeter.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to mask the intervention - as it is diet and physical activity, diet alone or standard care
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Nutrition

Model Details: Intervention: online or in hospital Diet: weekly one-to-one sessions for 4 weeks, then fortnightly (8 sessions total). Menus follow Eatwell guide/Food and Agriculture Organization with 20% energy deficit for overweight/obese and equicaloric for healthy weight. Physical activity: one-to-one supervised sessions with two-three supervised non-consecutive sessions as tolerated and prescribed based on individual assessment. Standard care: diet and physical activity information. Two counselling sessions (psychology) for motivation and adherence.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 26, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); GB (1)