Clinical trial NCT03031951: Lifestyle Intervention Program for Former Elite Athletes
Official title: Lifestyle Intervention Program for Former Elite Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Former athletes
Body composition
Adaptive thermogenesis
Physical activity
Energy expenditure
Sedentary behavior
Fat mass
Abdominal fat mass
Nutrition
Behavior modification
Lead sponsor: Faculdade de Motricidade Humana
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Given the lack of support for lifestyle management in post-career and considering the high rates of physical inactivity and overweight in former elite athletes, the aim of this research project is to analyze the efficacy and effectiveness of a lifestyle intervention in former athletes.

Detailed description: The physical preparation of the elite athlete results from a complex and very demanding daily training. In this process high energy expenditure (EE) occur compensated by a proportional energy intake, thus contributing to neutral energy balance and weight maintenance. However, a positive energy balance (and consequently an increase in weight) is expected after the end of the sports career if the energy intake is maintained for lower EE. While clinicians and researchers are concerned with the average individual whose physical activity (PA) level is far below the recommended exercise dose an often overlooked group are the former highly competitive athletes, who have been exposed to higher amounts of vigorous PA during times of training and competition.

It is common that upon retirement energy intake does not match the dramatic decrease in overall energy expenditure leading to a positive energy balance, and consequently weight gain. The change to a lower physical activity level does not induce an equivalent reduction in energy intake. Varying physical activity level from 1.8 to 1.4 over 7 days was not associated with a change of energy intake and there was no tendency for energy intake to drop as the sedentariness progressed.

In fact, elite athletes that became inactive are susceptible to various chronic diseases such as obesity, diabetes and cardiovascular disease. Not only obesity and its comorbidities are a major health problem as an increase in body weight and a higher risk for developing hypertension, type II diabetes and cardiovascular disease has been observed in athletes that retired from the sports career . However, the literature reports that this risk is only present in those retired athletes exposed to a sedentary lifestyle. In fact, the current levels of PA are more protective against the development of cardiovascular disease in former athletes than their past sports history. Although it is expected that the retired elite athlete will be engaged in regular PA throughout life, studies reveal that this assumption does not apply to all former athletes. This concern was addressed in the United States, namely within the National Football League where an obesity prevention program for the retired athletes was implemented. In Portugal \~50% of the former elite athletes are overweight/obese and \~30% are inactive, based on self-reports measures. Indeed no support is provided for maintaining a healthy lifestyle after the end of the sports career. If a healthy lifestyle promotion among post-career elite athletes would contribute to avoid the observed rates of overweight/obesity it is unknown. Considering this actual context, the aim of this research project is to analyze the effect of a lifestyle intervention in former athletes. To accomplish the goals the investigators will perform a 1 year randomized controlled trial with a 4-month lifestyle intervention and an 8-month follow-up in 100 volunteered former overweight (Body Mass index\>25 kg.m-2), inactive elite athletes that represented Portugal in international competitions during 1972-2012, ended their career for at least 2 years prior the study and are able to attend the educational sessions. Participants will be randomly assigned into 2 groups: i) dietary counseling (control group), or ii) behavioral lifestyle intervention, focusing on diet and PA. All participants will be screened at baseline, 4 months, and 12 months. A broad set of parameters will be assayed in each participant, namely: body composition, cardiorespiratory fitness, muscle strength, biochemical parameters, resting metabolic rate, nutritional intake, daily PA, and quality of life. These variables will allow the comprehension of the effects of a lifestyle modification on fatness, fitness and health-related parameters contributing also to further elucidate compensatory mechanisms associated with potential changes in weight and composition. To accomplish the main goal the research team will use established methods in the literature as well as novel procedures, which will enable the research team to overcome some of the limitations of previous studies. At the end of the study the investigators expect to have collected consistent data about whether a lifestyle intervention is or is not able to effectively decrease fatness while improving fitness and health-related markers. The research team believe that these data will help both non-governmental and governmental stakeholders in sports and education to make evidence based decisions, specifically the introduction and implementation of lifestyle programs in the transition to the post-career of elite athletes. The growing number of elite athletes supported by the government along with the recent EU report guidelines on dual careers in high-performance sports (ec.europa.eu/sport/news/2013/20130123-eu-guidelines-dualcareers_en.htm) requires further studies that test the role of preventive and educational programs for athletes in the areas of healthy living. The past experience of the research team in body composition, physical fitness, and objectively measured PA using cross-sectional and prospective study designs in athletic and non-athletic populations, as well as in the conduction of PA intervention clinical trials, together with the involvement of the Portuguese Olympic Committee as partners, supports the chances of successfully achieving the proposed objectives.

Eligibility criteria: Inclusion Criteria:

* Being a Former high-level athlete;
* Being Physical Inactive (not exercising for \>20 min at least 3 days/week);
* Being Overweight or Obese (BMI exceed≥25 kg/m2);
* Willing to be randomized to either control or intervention groups and follow the protocol to which they have been assigned;
* Willing to participate in the educational sessions performed at Faculdade de Motricidade Humana - Universidade de Lisboa;
* Unwilling to consider using weight loss medications;

Exclusion Criteria:

* Failure to complete the run-in for dietary intake and physical activity;
* Lack of support from primary health care provider or family members;
* Being unable or unwilling to give informed consent or communicate with local study staff;
* Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder;
* Eating disorders;
* Medical conditions such as thyroid disorders;
* Diabetes and cardiovascular disease or other medical condition known to affect energy balance homeostasis;
* Hospitalization for depression in past six months;
* Self-report of alcohol or substance abuse within the past twelve months, current consumption of more than 14 alcoholic drinks per week, and/or current acute treatment or rehabilitation program for these problems;
* Pregnancy or planning to get pregnant within the next 9 month, having been pregnant within the past 6 months or breastfeeding;
* History of weight loss surgery or liposuction procedures;
* Current participation in a weight loss program;
* In the past three months, weight loss exceeding 4.5 kg (such individuals may have difficulty losing additional weight) or successful attempts to lose weight within the past 6-month;
* Current use of medications for weight loss;
* Chronic treatment with systemic corticosteroids;
* Self-reported inability to walk two blocks;
* Inability to complete the study within the designated time frame because of plans to move out of the study area;
* Inability to attend the visits/appointments, evaluation measurements, and attend the intervention sessions at the Faculdade de Motricidade Humana - Universidade de Lisboa;

Primary outcomes:
measure: Whole body fat mass (FM)
timeFrame: 12 month
measure: Abdominal Fat Mass
timeFrame: 12 months
Secondary outcomes:
measure: Weight
timeFrame: 12 months
measure: Height
timeFrame: baseline
measure: Body mass index
timeFrame: 12 months
measure: Circumferences
timeFrame: 12 months
measure: Cardiorespiratory Fitness
timeFrame: 12 months
measure: Systolic blood pressure
timeFrame: 12 months
measure: Diastolic blood pressure
timeFrame: 9 months
measure: Blood Glucose levels
timeFrame: 12 months
measure: Blood lipid profiles
timeFrame: 12 months
measure: Blood insulin levels
timeFrame: 12 months
measure: Blood thyroid levels
timeFrame: 12 months
measure: Blood leptin levels
timeFrame: 12 months
measure: Lower muscle strength
timeFrame: 12 months
measure: Upper muscular strength
timeFrame: 12 months
measure: Eating self-regulation markers
timeFrame: 12 months
measure: Exercise Motivation
timeFrame: 12 months
measure: Raw BIA parameters - Resistance and Reactance
timeFrame: 12 months
measure: Raw BIA parameters - Phase Angle
timeFrame: 12 months
measure: Total body water, Intracellular water and Extracellular water
timeFrame: 12 months
measure: Macronutrient composition of the diet
timeFrame: 12 months
measure: Energy Intake
timeFrame: 12 months
measure: Free-living physical activity
timeFrame: 12 months
measure: Total energy expenditure
timeFrame: 12 months
measure: Physical activity energy expenditure
timeFrame: 12 months
measure: Adaptive Thermogenesis
timeFrame: 3 and 9 months
measure: Resting Energy Expenditure (REE)
timeFrame: 12 months
measure: Reported Quality of Life
timeFrame: 12 months
Other outcomes:
Locations:
city: Oeiras
country: Portugal
facility: Faculdade de Motricidade Humana
state: Cruz-Quebrada
Study officials:
affiliation: Faculty of Human Kinetics, University of Lisbon
name: Analiza Silva
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nunes CL, Rosa GB, Jesus F, Heymsfield SB, Minderico CS, Martins P, Sardinha LB, Silva AM. Interindividual variability in metabolic adaptation of non-exercise activity thermogenesis after a 1-year weight loss intervention in former elite athletes. Eur J Sport Sci. 2023 Aug;23(8):1761-1770. doi: 10.1080/17461391.2022.2147020. Epub 2022 Nov 28.
citation: Nunes CL, Carraca EV, Jesus F, Finlayson G, Francisco R, Silva MN, Santos I, Bosy-Westphal A, Martins P, Minderico C, Sardinha LB, Silva AM. Changes in food reward and intuitive eating after weight loss and maintenance in former athletes with overweight or obesity. Obesity (Silver Spring). 2022 May;30(5):1004-1014. doi: 10.1002/oby.23407. Epub 2022 Mar 28.
citation: Nunes CL, Jesus F, Francisco R, Matias CN, Heo M, Heymsfield SB, Bosy-Westphal A, Sardinha LB, Martins P, Minderico CS, Silva AM. Adaptive thermogenesis after moderate weight loss: magnitude and methodological issues. Eur J Nutr. 2022 Apr;61(3):1405-1416. doi: 10.1007/s00394-021-02742-6. Epub 2021 Nov 27.
citation: Silva AM, Nunes CL, Jesus F, Francisco R, Matias CN, Cardoso M, Santos I, Carraca EV, Finlayson G, Silva MN, Dickinson S, Allison D, Minderico CS, Martins P, Sardinha LB. Effectiveness of a lifestyle weight-loss intervention targeting inactive former elite athletes: the Champ4Life randomised controlled trial. Br J Sports Med. 2022 Apr;56(7):394-401. doi: 10.1136/bjsports-2021-104212. Epub 2021 Oct 1.
citation: Matias CN, Campa F, Nunes CL, Francisco R, Jesus F, Cardoso M, Valamatos MJ, Homens PM, Sardinha LB, Martins P, Minderico C, Silva AM. Phase Angle Is a Marker of Muscle Quantity and Strength in Overweight/Obese Former Athletes. Int J Environ Res Public Health. 2021 Jun 21;18(12):6649. doi: 10.3390/ijerph18126649.
citation: Campa F, Matias CN, Nunes CL, Monteiro CP, Francisco R, Jesus F, Marini E, Sardinha LB, Martins P, Minderico C, Silva AM. Specific Bioelectrical Impedance Vector Analysis Identifies Body Fat Reduction after a Lifestyle Intervention in Former Elite Athletes. Biology (Basel). 2021 Jun 12;10(6):524. doi: 10.3390/biology10060524.