Lifestyle Intervention Program for Former Elite Athletes (Champ4Life)
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|ClinicalTrials.gov Identifier: NCT03031951|
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Lifestyle Intervention Group||Not Applicable|
Show Detailed Description
|Study Type :||Interventional|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Lifestyle Intervention Program for Former Elite Athletes|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Lifestyle Intervention Group
Subjects will attend 12 educational sessions for a healthy lifestyle in groups of 10-15 participants, for approximately 4 months. Sessions will last 90-120 minutes and will include educational content and practical application classroom exercises in the areas of physical activity and exercise, diet and eating behavior, and behavior modification. The inclusion of self-regulation skills, such as pedometer use, recording food regularly and monitoring weight, is also part of the curriculum. Participants will be instructed and motivated to make small but enduring reductions in caloric intake and to increase energy expenditure to induce a daily energy deficit of approximately 300 kcal. Weight will be monitored weekly.
Behavioral: Lifestyle Intervention Group
Subjects will attend 12 educational sessions for a healthy lifestyle in groups of 10-15 participants, for approximately 4 months. Sessions will last 60-90 minutes and will include educational content and practical application classroom exercises in the areas of physical activity and exercise, diet and eating behavior, and behavior modification. The inclusion of self-regulation skills, such as pedometer use, recording food regularly and monitoring weight, is also part of the curriculum.Participants will be instructed and motivated to make small but enduring reductions in caloric intake and to increase energy expenditure to induce a daily energy deficit of approximately 300 kcal. Weight will be monitored weekly.
Other Name: Lifestyle Intervention Programme
No Intervention: Control Group - Waiting List
Participants assigned to the control group will have access to the intervention after the 12-month period - waiting list. Meanwhile, participants will receive multimedia health information fortnightly by e-mail over the first 4-month period. The health information covers healthy lifestyle topics.
During the 12 months of study participation, control group participants will be instructed to maintain their baseline level of physical activity. Individuals assigned to the control group will be asked to maintain their current nutritional practices and physical activity patterns.
- Whole body fat mass (FM) [ Time Frame: 12 month ]
To estimate total FM, dual energy X-ray absorptiometry (Hologic Explorer-W, Waltham, USA) will be used A whole-body scan will be performed and the attenuation of X-rays pulsed between 70 and 140 kV synchronously with the line frequency for each pixel of the scanned image will be measured.
Total abdominal FM by identifying a specific region of interest (ROI) within the analysis programme.
- Abdominal Fat Mass [ Time Frame: 12 months ]Specific DXA ROIs for abdominal regional fat will be defined as follows: ROI 1, the upper edge of the second lumbar vertebra (approximately 10 cm above the L4 to L5) to above the iliac crest and laterally encompasses the entire breadth of the abdomen, thus determining total abdominal fat mass.
- Weight [ Time Frame: 12 months ]Subjects will have their weight measured wearing a bathing suit to the nearest 0.01 kg with a stadiometer (Seca, Hamburg, Germany)
- Height [ Time Frame: baseline ]Subjects will have their height measured without shoes to the nearest 0.1 cm with a stadiometer (Seca, Hamburg, Germany).
- Body mass index [ Time Frame: 12 months ]Body mass index will be calculated using the formula [weight(kg)/height2(m2)].
- Circumferences [ Time Frame: 12 months ]Subjects will have their. Waist circumference will be measured immediately above the iliac crest. Hip circumference will be assessed is determined at the maximum perimeter of the hips. Arm and thigh circumferences will be assessed at the level of the skinfold measurement. Calf circumference will be assessed at the at the maximum perimeter of the calf. Circumference measurements are performed twice and the arithmetic mean of both values is considered as the final value.
- Cardiorespiratory Fitness [ Time Frame: 12 months ]Maximal oxygen uptake (VO2max) capacity will be assessed using the Bruce maximal exercise test protocol performed on a variable speed and incline treadmill (Quinton Treadmill, Model 640, 90TM Series). VO2max is achieved when at least 2 of the following 3 criteria are obtained: a heart rate at or above the age-predicted maximum, and/or a respiratory exchange ratio greater than 1, and/or no increase in VO2max despite further grade increases.
- Systolic blood pressure [ Time Frame: 12 months ]Three measurements of systolic blood pressure are obtained with the participant in the sitting position using a digital sphygmomanometer. The blood pressure cuff-fixed on the nondominant upper arm is loosened during the two minutes pause between the measurements. The arithmetic means of the second and third reading are considered as the participants' blood pressure and pulse values, respectively. Overall, there is a rest of approximately five minutes before the second blood pressure measurement is carried out
- Diastolic blood pressure [ Time Frame: 9 months ]Three measurements of diastolic blood pressure are obtained with the participant in the sitting position using a digital sphygmomanometer. The blood pressure cuff-fixed on the nondominant upper arm is loosened during the two minutes pause between the measurements. The arithmetic means of the second and third reading are considered as the participants' blood pressure. Overall, there is a rest of approximately five minutes before the second blood pressure measurement is carried out
- Blood Glucose levels [ Time Frame: 12 months ]Blood glucose levels will be performed in serum samples using coloured enzymatic tests, in an automated analyser (Cobas Integra 400).
- Blood lipid profiles [ Time Frame: 12 months ]Blood lipid profile, including total cholesterol, high density lipoprotein cholesterol (HDL) will be performed in serum samples using coloured enzymatic tests, in an automated analyser (Cobas Integra 400).
- Blood insulin levels [ Time Frame: 12 months ]Blood insulin levels assessment will be performed in an automated analyser (Cobas Integra 400) by eletroquimioluminescence.
- Blood thyroid levels [ Time Frame: 12 months ]Blood thyroid panel (T3, T4, TSH) will be run by immunoassay with chemiluminescent detection (Millipore Corp., Billerica, MA).
- Blood leptin levels [ Time Frame: 12 months ]Serum levels of leptin will be measured by ELISA.
- Lower muscle strength [ Time Frame: 12 months ]One repetition leg press maximum test (1RM) that measure the maximal weight a subject can lift with one repetition will be used. Before each assessment the participant will be instructed to conduct a 5min warmup period, preceded by a respective familiarization period with the specific test for the lower limb. The evaluation of the maximum strength of the leg will be made by performing a horizontal leg press isometric test (S0409, BPH) with the bent leg and the knee joint at an angle of 110 °. Participants will complete 5 maximal voluntary repetitions lasting 34 seconds, and a period of rest between reps 60s. All participants will be asked to produce strength the fastest possible in all repetitions. The Plux software (Biosignalsplux) will be considered to analyze the highest value between the maximal voluntary repetitions.
- Upper muscular strength [ Time Frame: 12 months ]Handgrip strength test evaluates maximal isometric force of the forearm muscle and will be assessed by a portable hand dynamometer JAMAR plus digital (Sammons Preston, Bolingbrook, IL). Participants will be assessed on both hands alternately. Prior to the test, the grip dynamometer will be adjusted to the size of the hand of each subject. Each participant will be assessed on both hands alternately until add up three attempts for each hand. In each attempt the subject will exert the maximal grip strength on the handgrip dynamometer with the assessed hand during 5 seconds. After each attempt there will be a resting period of 60 seconds that will be used both for recovery and for changing the handgrip dynamometer to the opposite hand.
- Eating self-regulation markers [ Time Frame: 12 months ]The reward value of food (i.e., implicit wanting/explicit liking and wanting) will be measured by a computer procedure, the Leeds Food Preference Questionnaire (LFPQ) [38, 39], which uses a 'forced choice' reaction time measure of implicit wanting in addition to explicit subjective measures of liking and wanting for visual food stimuli varying in fat content and taste. Implicit wanting is operationalized as the reaction time of each pair trial decision. Thus, the speed with which one category of stimuli is chosen relative to alternative categories provides a quantifiable measure of implicit wanting for each food category in the procedure.
- Exercise Motivation [ Time Frame: 12 months ]The Behavioral Regulation in Exercise Questionnaire - 3 (BREQ-3) will be used to assess motivations to engage in exercise. Prior research has supported BREQ's factor structure and reliability (Cronbach's alphas > 0.70).
- Water compartments [ Time Frame: 12 months ]Total-body water and its compartments will be assessed by Bioelectrical impedance spectroscopy analysis (model 4200B; Xitron Technologies, San Diego, CA, USA). Before the test, subjects were instructed to lie in a supine position with their arms and legs abducted at a 458 angle for 10 min. This impedance spectra was modelled with the Cole-Cole cell suspension model to derive a theoretical impedance at zero and infinity frequency, based on a non-linear curve fitting from the measured resistance and reactance. Intracellular water and extracellular water were predicted from the Hanai mixture theory, and TBW was estimated by the sum of intracellular water and extracellular water. Considering ten repeated measures, the TEM and CV for TBW were 0·47 litres and 1·1% respectively.
- Phase angle [ Time Frame: 12 months ]Phase angle will be assessed by Bioelectrical impedance spectroscopy analysis (model 4200B; Xitron Technologies, San Diego, CA, USA). Before the test, subjects were instructed to lie in a supine position with their arms and legs abducted at a 458 angle for 10 min. This impedance spectra was modelled with the Cole-Cole cell suspension model to derive a theoretical impedance at zero and infinity frequency, based on a non-linear curve fitting from the measured resistance and reactance. The frequency 50 kHz will be used for phase angle analysis.
- Macronutrient composition of the diet [ Time Frame: 12 months ]Food records will also be collected to characterize macronutrient composition of the diet in the 3 moments using a software package (Food Processor SQL, ESHA Research, Salem, OR, USA).
- Energy Intake [ Time Frame: 12 months ]
When total energy expenditure (TEE) is obtained in conjunction with measured body composition, then two terms of the energy balance equation are known, namely ES and EE. From equation 1 it is possible to solve for average energy intake during the course of the study.
The magnitude of compensation will be calculated as the difference between achieved energy imbalance and energy expenditure.
- Free-living physical activity [ Time Frame: 12 months ]The amount of activity assessed by the Actigraph accelerometer will be expressed as minutes per day spent in different intensities. The cutoff values used to define the intensity of PA and therefore to quantify the mean time in each intensity (sedentary, light, moderate or vigorous) will be: sedentary: < 100 counts·min-1; light: 100-2019 counts·min-1; moderate: 2020-5998 counts·min-1 (corresponding to 3-5.9 METs); vigorous: ≥ 5999 counts·min-1 (corresponding to ≥6 METs).
- Total energy expenditure [ Time Frame: 12 months ]Total energy expenditure will be assessed by the Actigraph accelerometer using the Crouter et al equations.
- Physical activity energy expenditure [ Time Frame: 12 months ]Physical activity energy expenditure (PAEE) will be calculated as total energy expenditure (TEE) minus (0.1*TEE + REE), assuming the termic effect of food represents 10% of TEE, and REE represents Resting energy expenditure.
- Adaptive Thermogenesis [ Time Frame: 3 and 9 months ]In order to predict resting energy expenditure (REE) at baseline, a gender specific regression equation using FFM and FM as the independent predictor will be generated. This equation will then be used to predict REE at 3 and after a 9-month follow-up, using the measured values of FM and FFM at these time points. To disclose any adaptations in REE not accounted for by changes in FFM, adaptive response will be assessed as 1 minus the ratio between the actual to the expected/predicted REE, multiplied by 100. Positive values indicate a decrease in REE beyond that expected by changes in body composition (actual REE below predicted REE) whereas negative values represent a change in REE equal to or greater than the predicted REE (actual REE higher than predicted REE).
- Resting Energy Expenditure (REE) [ Time Frame: 12 months ]
The MedGraphics CPX Ultima (MedGraphics Corporation, Breezeex Software) indirect calorimeter will be used to measure breath-by-breath oxygen consumption (V̇O2 ) and carbon dioxide production (V̇CO2) using a facial mask. The oxygen and carbon dioxide analyzers will be calibrated in the morning before testing using known gas concentration. Before testing, participants will be instructed about all the procedures and asked to relax, breathe normally, not to sleep, and not to talk during the evaluation. Total rest duration will be 45 minutes, participants lied supine for 15 minutes covered with a blanket and the calorimeter device will then be attached to the mask and breath by breath V̇O2 and V̇CO2 will be measured for 30 min period.
The mean V̇O2 and V̇CO2 of 5 min steady states will be used in Weir equation and the period with the lowest REE will be considered for data analysis.
- Reported Quality of Life [ Time Frame: 12 months ]To measure general health-related quality of life, participants will complete the Short-Form Health Survey (SF-36) questionnaire , with a total of 36 items composed of eight dimensions: Physical functioning (Cronbach's a = .83), physical role limitations (Cronbach's a = .89), bodily pain (Cronbach's a = .88), general health (Cronbach's a = .82), emotional role limitations (Cronbach's a = .74), social functioning (Cronbach's a = .71), vitality (Cronbach's a = .86), and mental health (Cronbach's a = .90). Higher scores indicate better health-related quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031951
|Contact: Analiza Silvaemail@example.com|
|Faculdade de Motricidade Humana||Recruiting|
|Oeiras, Cruz-Quebrada, Portugal, 1409-002|
|Contact: Analiza Silva 962903643 firstname.lastname@example.org|