- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03060161
Health in the Right Measure: Promoting Healthy Food and Regular Physical Activity Practice for UFRJ Servers (HRM)
Health in the Right Measure: Promoting Healthy Food and Regular Physical Activity Practice for UFRJ Server
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The initial goal of the project is to serve approximately thirty UFRJ servers at each edition. The project will be developed in up to two annual editions over a period of five years. After the selection of the candidates, an ambitious meeting will be held with all the participants in order to clarify the objectives and the other stages of the project.
Participants will then be scheduled for laboratory tests and consultations for medical evaluation (exercise test), nutritional assessment and physical evaluation. The anthropometric evaluation will be performed according to previously established protocols. Measurements of body weight, height and waist, abdominal, neck and hip circumference will be performed. The evaluation of the body composition will be performed using the multi-frequency electrical bioimpedance apparatus (Biodynamics® model 450). The usual food consumption quality will be evaluated through dietary records of 3 days (typical 2 days and 1 atypical). In order to evaluate the possible changes in the routine of physical activity practice, the international physical activity questionnaire (IPAQ) will be used in short form. The nutritional consultations will be carried out by nutritionists in the Nutritional Assessment Laboratory (NAL) of the Josué de Castro Nutrition Institute (JCNI).
Blood samples will be collected at the Laboratory of Clinical Analysis of the Faculty of Pharmacy of UFRJ or at the Clinical Pathology Service of the University Hospital Clementino Fraga Filho by properly trained personnel with disposable materials. Blood samples will be collected after a 12 hour fasting for analysis of the complete blood count, lipidogram, liver enzymes (aspartate transaminase and alanine transaminase), glycemia, glycated hemoglobin, free thyroxine and thyroid stimulating hormone.
After performing these evaluations, an individualized physical exercise program will be proposed according to each participant's level of physical activity and health conditions. Participants will also receive individualized nutritional guidance. In case of failure in the stress test the participant will not be able to participate in the physical exercise program, however, he will be invited to remain in activities aimed at promoting healthy eating habits.
Throughout the project, collective motivational activities will be carried out to promote healthy eating (culinary workshops, talk wheels and others) and individual activities with all participants, in order to evaluate the adherence of nutritional guidelines and to exchange experiences among them.
At the end of the project intervention period (12 weeks), the participants will again be submitted to laboratory examination and nutritional assessment: anthropometric and body composition evaluation and evaluation of changes in eating habits.
A collective closure meeting will be held at the end of the project intervention stage and all participants will be informed and will have access to the results of their evaluations to date.
In the next six months participants will be invited to monthly motivational collective activities (sporting challenges, conversation wheel, culinary workshop) as a way to stimulate them to maintain routine physical activities and changes in eating habits.
At the end of three months after the end of the intervention period (6 months of follow-up), the participants will be submitted to nutritional assessment. At the end of the six months after the end of the intervention period, the participants will be submitted to the same evaluations performed three months after the intervention.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Rio de Janeiro, Brasile, 21941-902
- Vanessa Chaia Kaippert
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Be a server of UFRJ
- Be able to practice some regular physical activity
- Be willing to participate in the proposed activities.
Exclusion Criteria:
- N/A
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Health in the right measure
Nutrition counseling and guidance for regular physical activity. An individualized physical exercise program will be proposed according to each participant's level of physical activity and health conditions. Participants will also receive individualized nutritional guidance. Throughout the project, collective motivational activities will be carried out to promote healthy eating (culinary workshops, talk wheels and others) and individual activities with all participants, in order to evaluate the adherence of nutritional guidelines and to exchange experiences among them. |
Nutritional monitoring and individual guidance on regular physical exercise.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Promote healthy eating habits
Lasso di tempo: baseline, after 3 and 9 months
|
Changes in dietary habits will be assessed by completing dietary records for three days
|
baseline, after 3 and 9 months
|
Combat physical inactivity
Lasso di tempo: baseline, after 3 and 9 months
|
Changes in routine physical activity will be assessed through the International Physical Activity Questionnaire (IPAQ) in the short form.
|
baseline, after 3 and 9 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Effects of lifestyle change on body weight
Lasso di tempo: baseline, after 3, 6 and 9 months
|
Changes in body weight will be evaluated.
|
baseline, after 3, 6 and 9 months
|
Effects of lifestyle change on body circumference
Lasso di tempo: baseline, after 3, 6 and 9 months
|
Changes in body circumference will be evaluated.
|
baseline, after 3, 6 and 9 months
|
Effects of lifestyle change on body composition
Lasso di tempo: baseline, after 3, 6 and 9 months
|
Changes in body composition will be evaluated by electrical bioimpedance
|
baseline, after 3, 6 and 9 months
|
Effects of lifestyle change on biomarkers.
Lasso di tempo: baseline, after 3 and 9 months
|
Lipid and glycemic profile will be evaluated.
|
baseline, after 3 and 9 months
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Eliane Oliveira, Doctor, Adjunct Professor
Pubblicazioni e link utili
Pubblicazioni generali
- Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
- Lukaski HC, Johnson PE, Bolonchuk WW, Lykken GI. Assessment of fat-free mass using bioelectrical impedance measurements of the human body. Am J Clin Nutr. 1985 Apr;41(4):810-7. doi: 10.1093/ajcn/41.4.810.
- Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.
- Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Manuel Gomez J, Lilienthal Heitmann B, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, M W J Schols A, Pichard C; ESPEN. Bioelectrical impedance analysis-part II: utilization in clinical practice. Clin Nutr. 2004 Dec;23(6):1430-53. doi: 10.1016/j.clnu.2004.09.012.
- Ferreira VA, Magalhaes R. [Nutrition and health promotion: recent perspectives]. Cad Saude Publica. 2007 Jul;23(7):1674-81. doi: 10.1590/s0102-311x2007000700019. Portuguese.
- Flegal KM, Shepherd JA, Looker AC, Graubard BI, Borrud LG, Ogden CL, Harris TB, Everhart JE, Schenker N. Comparisons of percentage body fat, body mass index, waist circumference, and waist-stature ratio in adults. Am J Clin Nutr. 2009 Feb;89(2):500-8. doi: 10.3945/ajcn.2008.26847. Epub 2008 Dec 30.
- Sookoian S, Pirola CJ. Genetics of the cardiometabolic syndrome: new insights and therapeutic implications. Ther Adv Cardiovasc Dis. 2007 Oct;1(1):37-47. doi: 10.1177/1753944707082702.
- Zeyda M, Stulnig TM. Obesity, inflammation, and insulin resistance--a mini-review. Gerontology. 2009;55(4):379-86. doi: 10.1159/000212758. Epub 2009 Apr 8.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 123456 CEP
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Health in the right measure
-
Philips HealthcareThe Royal Marsden HospitalCompletato
-
Universiteit AntwerpenUniversity Hospital, Antwerp; Cliniques universitaires Saint-Luc- Université...ReclutamentoEmofilia A | Emofilia BBelgio
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)ReclutamentoEducazione al cancro | Educazione al cancro in lingua spagnolaStati Uniti, Porto Rico