Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Diabetes Mellitus, Type 2

Diabetes Mellitus

Obesity

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Nutrition classes for 1 hour \& 30 minutes once a week for 16 weeks + motivational interviewing (4 individual sessions)

Nutrition

Strength Training twice a week for 1 hour a day for 16 weeks + Nutrition once a week for 1 hour \& 30 minutes for 16 weeks + motivational interviewing (4 individual \& 4 group sessions)

Strength Training & Nutrition

Circuit Training twice a week for 1 hour a day for 16 weeks + Nutrition once a week for 1 hour \& 30 minutes for 16 weeks + motivational interviewing (4 individual \& 4 group sessions)

Circuit Training & Nutrition

Michael I Goran, PhD

We are conducting an intervention study to examine the effects of a 16-week exercise and diet interventions on prevention of disease, specifically type 2 diabetes and heart disease, in Latino youth. Eighty overweight Latino boys and girls will be recruited and placed in one of the following intervention groups: 1) Control Group (delayed intervention), 2) Dietary Education Group (nutrition education focused on reducing sugar \& soda, increased fiber \& whole grain intake), 3) Combination of Strength Training (twice/week for 60 min, progressive increases in exercise volume and intensity) + Dietary Education (nutrition education focused on reducing sugar \& soda, increased fiber \& whole grain intake) or 4) Combination of Circuit Training (twice/week for 60 min, aerobic + strength training exercises) + Dietary Education (same as above). We will assess which intervention group has the most effects on health parameters such as weight, body composition, and insulin related measures.

The overall historical goal of this grant has been to examine the determinants of insulin resistance in children, especially the role of total fat and visceral fat during pubertal development in "high risk" minority children. Our previous longitudinal work has provided the platform to propose a new intervention phase of this research. This new emphasis is justified based on the magnitude of the pediatric obesity problem, particularly in susceptible ethnic groups, and the need to design and test novel interventions to reduce not just obesity, but the profound insulin resistance that we have observed in overweight minority children. Insulin resistance is thought to be central (and perhaps causative) to several metabolic abnormalities associated with type 2 diabetes and cardiovascular disease. Thus, interventions aimed at improving insulin resistance in susceptible children could be an effective means in the primary prevention of type 2 diabetes and cardiovascular disease.

The overall objective of this proposal is therefore to conduct a randomized controlled study to examine the effects of 16-week exercise and diet interventions on insulin sensitivity, insulin secretion, beta-cell function, and body fat distribution. Overweight Hispanic boys and girls (n=80) will be recruited and randomized to one of the following interventions:

Ø Control (delayed intervention) Ø Modification of carbohydrate intake (reduced sugar \& soda, increased fiber \& whole grain intake) using an individualized healthy exchange system and motivational interviewing Ø Strength training + modification of carbohydrate intake Ø Circuit Training + modification of carbohydrate intake

This study will provide new information on the effects of these interventions on primary outcomes at the level of body composition (total lean and fat mass, visceral fat, intramyocellular fat and liver fat) and insulin related measures (insulin secretion \& sensitivity and beta-cell function). The hypotheses are:

1. All interventions will have separate and independent effects on improving insulin resistance
2. Strength training will improve insulin resistance by re-distribution of body fat (lower visceral fat, intramyocellular lipid and liver fat)
3. Carbohydrate modification will improve insulin secretion and beta-cell function
4. Circuit training will have similar improvements in insulin resistance and have more improvements on adiposity compared to the strength training group.
5. The aforementioned effects on insulin dynamics will be independent of any effects of either intervention on weight loss or loss in whole body fat.

The overall rationale for these interventions is based on three main factors. First, preliminary data are presented in overweight Hispanic boys showing that 16-weeks of strength training significantly improves insulin sensitivity in the absence of a reduction in total body fat and in the absence of any dietary intervention. Second, preliminary data suggests that overweight Hispanic children consume high levels of simple sugar, and low levels of fiber and complex carbohydrates, and data from the literature suggests that modification of carbohydrate consumption (reduced sugar, increased fiber \& whole grain) can improve glucose control independent of body composition. Third we provide new preliminary data showing that the only dietary variable associated with insulin dynamics in overweight Hispanic children was high sugar intake which was associated with poor beta-cell function.

We have chosen to focus on Hispanic children because they are an understudied, high-risk population, and display significant obesity-related metabolic abnormalities probably emanating from profound insulin resistance (see preliminary data). In support of the feasibility of our proposal, we have developed extensive expertise in recruiting and retaining research volunteers from the large Hispanic population of East Los Angeles, we have an experienced multi-disciplinary group of investigators, and the University of Southern California has the necessary clinical research infrastructure to tackle this project. If our hypotheses are borne out, it will provide evidence for the incorporation of strength training and more specific and individualized dietary recommendations in the prevention and management of obesity, type 2 diabetes, and cardiovascular risk in overweight Hispanic youth.

Strength and Nutrition Outcomes for Latino Adolescents

Intra-Abdominal Fat and Risk of Disease in Adolescents

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

University of Southern California

Professor

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Leukemia

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphosarcoma

STEEL strength training will consist of progressive periodised training, in which the intensity is set to fit the individual's starting level and then gradually increases. During Week 1 to Week 5, the relative load will correspond to a 12-repetition maximum (RM). During Week 5 to Week 10, the relative load will be 10 RM, and during Week 11 to Week 16, the relative load will be 8 RM. The exercises will mostly consist of compound movements that activate the large muscle groups of the legs, back, arms and torso.

There will be 10 stations that include both strengthening and cardiovascular exercises, such as squats, hopping, crunches, stationary running, front-lying swimming, ski jumps, push-ups, ball throws, ring pulls, and hopscotch. Each station lasts 45 seconds, and there will be a 15-second break between each station. The circuit is repeated for three rounds. To ensure progression in intensity similar, we will progress the participants' rating of perceived exertion (RPE) over time. During Week 1 to Week 5, the RPE during exercises will be 6-7. During Week 5 to Week 10, the RPE will be 8-9, and during Week 11 to Week 16, the RPE will be 10.

STEEL

Circuit training

Henrik Riel, PhD

Pascal Madeleine, DSc

Martin K Fridh

Henrik Riel

Mathias Rathe

Clara Vad

We aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. Based on randomization, they will either 1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training. STEEL training involves exercises for major muscle groups using free weights, body weight, or tailored machines. Circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. The training takes place in local centers either with friends or with other participants in the project. Before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. The effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and blood analysis).

The trial is designed as a national randomised clinical trial. Participants will be stratified by sex and block randomised (block sizes of 2 to 6) at 1:1 to either STEEL or the circuit training programme. A researcher not involved in the trial will generate the allocation sequence using a random number generator and is the only person who will know the block sizes. The study will be conducted at Aalborg University Hospital, Rigshospitalet, Odense University Hospital, and Aarhus University Hospital and was designed in collaboration with parents of childhood cancer survivors and an adult childhood cancer survivor suffering from late effects. Participants must attend three examinations at their respective hospitals: baseline and after 8 and 16 weeks.

Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents

Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents - The STEEL Study - a National Multicenter Randomised Controlled Study

De-identified data will be made available upon reasonable request.

Measured in Nm based on tests of knee extension and flexion and elbow extension and flexion using handheld dynamometry

We will use the Danish version of the Pediatric Quality of Life Inventory (PedsQL™) 4.0 Generic Core scales and the PedsQL™ Multidimensional Fatigue scales (5,9) to assess health-related quality of life. The PedsQL is a brief 23-item measurement model that evaluates quality of life in four areas: physical, emotional, social and school functioning. The questionnaire scores range from 0 to 100, and higher scores indicate better quality of life. The PedsQL™ Multidimensional Fatigue includes 18 questions related to fatigue and uses the same scoring as the PedsQL

We will assess participants' step counts throughout the intervention using a Garmin vívosmart® 5 watch (Garmin Ltd., Kansas, USA).

We will assess participants' caloric expenditure (KCAL) throughout the intervention using a Garmin vívosmart® 5 watch (Garmin Ltd., Kansas, USA).

we will test the 1 repetition maximum (RM) in the leg press and chest press machines

We will measure the bone mineral density of the lumbar spine (L1-L4) calculated as the Z-score and body composition (%body fat, lean body mass, and skeletal muscle mass) by a dual-energy-X-ray absorptiometry scanner located at each hospital.

Using a digital hand dynamometer, we will measure continuous isometric handgrip force and rate of force development.

We will use a 30-second sit-to-stand test to evaluate strength, endurance, and rate of force development of the lower extremities.

We will perform a 6-minute walk test to evaluate cardiorespiratory fitness and walking endurance

Exercise compliance and fidelity will be measured using training diaries, which the participants fill out themselves after the unsupervised training sessions and by the physiotherapist during the supervised training sessions. Exercise compliance relates to whether the training sessions have been performed, and fidelity relates to whether the exercises have been performed as prescribed regarding the number of repetitions, sets, and intensity.

Adverse events will be collected throughout the trial and graded 1 to 5 according to the Common Terminology Criteria for Adverse Events v4.03. Participants are asked to contact the responsible clinician at the hospital where they were enrolled as soon as they experience any adverse event.

We will use a 0 (no pain) to 10 (worst pain imaginable) Numerical Rating Scale to assess movement-evoked pain during the past week

We will assess participant satisfaction with their respective intervention using a 5-point rank scale ranging from 'very dissatisfied' to 'very satisfied'.

Analysed from a blood sample and measured in mmol/L

Analysed from a blood sample and measured in mmol/mol

Analysed from a blood sample and measured in mU/L

Analysed from a blood sample and measured in ng/mL

Analysed from a blood sample and measured in pg/mL

Calculated as fasting plasma glucose (mmol/L x fasting plasma glucose ((μU/L)/22.5) to estimate β-cell function (HOMA-B) and insulin-resistance (HOMA-IR2)

Measured as kg/m² for adolescents aged 18 or 19 years and BMI standard deviation (SD) scores for children aged 10-17 years based on national reference material.

Measured in kilograms based on dual-energy X-ray absorptiometry (DXA)

Measured in kilograms based on dual-energy X-ray absorptiometry (DXA) adjusted for sex and pubertal stage

Visual illustration of Tanner staging (I-V) regarding both genders

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Strength and Nutrition Outcomes for Latino Adolescents	NCT00697580	Obesity Type 2 Diabetes Cardiovascular ... Cancer	Nutrition Strength Traini... Circuit Trainin...	14 Years - 18 Years	University of Southern California
Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents	NCT06299722	Cancer	STEEL Circuit trainin...	10 Years - 19 Years	Aalborg University
Strength and Nutrition Outcomes for Latino Adolescents	NCT00697580	Obesity Type 2 Diabetes Cardiovascular ... Cancer	Nutrition Strength Traini... Circuit Trainin...	14 Years - 18 Years	University of Southern California
Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents	NCT06299722	Cancer	STEEL Circuit trainin...	10 Years - 19 Years	Aalborg University
Strength and Nutrition Outcomes for Latino Adolescents	NCT00697580	Obesity Type 2 Diabetes Cardiovascular ... Cancer	Nutrition Strength Traini... Circuit Trainin...	14 Years - 18 Years	University of Southern California
Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents	NCT06299722	Cancer	STEEL Circuit trainin...	10 Years - 19 Years	Aalborg University

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