NCT03031951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

4.1 years

First QC Date

January 16, 2017

Last Update Submit

February 1, 2021

Conditions

Keywords

Former athletesBody compositionAdaptive thermogenesisPhysical activityEnergy expenditureSedentary behaviorFat massAbdominal fat massNutritionBehavior modification

Outcome Measures

Primary Outcomes (2)

  • Whole body fat mass (FM)

    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.

    12 month

  • Abdominal Fat Mass

    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.

    12 months

Secondary Outcomes (27)

  • Weight

    12 months

  • Height

    baseline

  • Body mass index

    12 months

  • Circumferences

    12 months

  • Cardiorespiratory Fitness

    12 months

  • +22 more secondary outcomes

Study Arms (2)

Lifestyle Intervention Group

EXPERIMENTAL

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

Control Group - Waiting List

NO INTERVENTION

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.

Interventions

The intervention group will start the lifestyle intervention with a 60-minute nutrition appointment given by a certified dietitian. This meeting is intended to provide a well-balanced personalized diet plan, calculated to create a moderate reduction from \~300 to 500kcal/day according to each participant's energy requirements and preferences. Two additional follow-up appointments are also planned to adjust the individual energy requirements throughout the intervention. 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. Weight will be monitored weekly.

Also known as: Lifestyle Intervention Programme
Lifestyle Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Motricidade Humana

Oeiras, Cruz-Quebrada, 1409-002, Portugal

Location

Related Publications (15)

  • Stubbs RJ, Hughes DA, Johnstone AM, Horgan GW, King N, Blundell JE. A decrease in physical activity affects appetite, energy, and nutrient balance in lean men feeding ad libitum. Am J Clin Nutr. 2004 Jan;79(1):62-9. doi: 10.1093/ajcn/79.1.62.

    PMID: 14684398BACKGROUND
  • Miller MA, Croft LB, Belanger AR, Romero-Corral A, Somers VK, Roberts AJ, Goldman ME. Prevalence of metabolic syndrome in retired National Football League players. Am J Cardiol. 2008 May 1;101(9):1281-4. doi: 10.1016/j.amjcard.2007.12.029. Epub 2008 Mar 7.

    PMID: 18435958BACKGROUND
  • Pihl E, Jurimae T. Relationships between body weight change and cardiovascular disease risk factors in male former athletes. Int J Obes Relat Metab Disord. 2001 Jul;25(7):1057-62. doi: 10.1038/sj.ijo.0801642.

    PMID: 11443506BACKGROUND
  • Pihl E, Zilmer K, Kullisaar T, Kairane C, Magi A, Zilmer M. Atherogenic inflammatory and oxidative stress markers in relation to overweight values in male former athletes. Int J Obes (Lond). 2006 Jan;30(1):141-6. doi: 10.1038/sj.ijo.0803068.

    PMID: 16158088BACKGROUND
  • Dey SK, Ghosh C, Debray P, Chatterjee M. Coronary artery disease risk factors & their association with physical activity in older athletes. J Cardiovasc Risk. 2002 Dec;9(6):383-92. doi: 10.1097/01.hjr.0000049244.21319.20.

    PMID: 12478209BACKGROUND
  • Kujala UM, Marti P, Kaprio J, Hernelahti M, Tikkanen H, Sarna S. Occurrence of chronic disease in former top-level athletes. Predominance of benefits, risks or selection effects? Sports Med. 2003;33(8):553-61. doi: 10.2165/00007256-200333080-00001.

    PMID: 12797837BACKGROUND
  • Buchwald H, Roberts AJ. The HOPE (heart, obesity, prevention, education) program for former NFL players. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):573-5. doi: 10.1016/j.soard.2014.02.030. Epub 2014 Mar 1. No abstract available.

    PMID: 24958646BACKGROUND
  • Batista C, Soares JM. Are former athletes more prone to asthma? J Asthma. 2013 May;50(4):403-9. doi: 10.3109/02770903.2013.776075. Epub 2013 Apr 8.

    PMID: 23489224BACKGROUND
  • Nunes CL, Jesus F, Rosa GB, Marianito M, Francisco R, Bosy-Westphal A, Minderico CS, Martins P, Sardinha LB, Silva AM. Interindividual variability in energy intake and expenditure during a weight loss intervention. Appetite. 2024 Feb 1;193:107162. doi: 10.1016/j.appet.2023.107162. Epub 2023 Dec 13.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

ObesityMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Analiza Silva

    Faculty of Human Kinetics, University of Lisbon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 26, 2017

Study Start

September 1, 2016

Primary Completion

October 1, 2020

Study Completion

January 31, 2021

Last Updated

February 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations