Interdisciplinary Intervention in Patients With Obesity and Other Metabolic Diseases

Obesity Clinical Trial

Official title:

Interdisciplinary Intervention Project - Promotion and Rehabilitation in Patients With Obesity and Other Metabolic Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573688
• Other study ID #: LIDM-2014-GEO
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: August 2018

Study information

• Verified date: February 2020
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the research study will be assess the effectiveness of a long-term interdisciplinary lifestyle in many aspects including food intake, psychological symptoms, physical activity habits, energy expenditure, body composition and anthropometric measurements in adults obese.

Description:

Participants will be recruited after dissemination of the program in the local media and internet.

They will go through a short interview to evaluate inclusion and exclusion criteria. Thus, all obese adults will be submitted to an interdisciplinary lifestyle modification therapy according the inclusion criteria.

The interdisciplinary therapy will consist of nutritional, physical exercise, psychological and physiotherapy support during the course of one year, according the literature the investigators promote a long term therapy to control obesity and metabolic diseases.

The participants will be evaluated at baseline and after the therapy in accordance with Ethical guidelines.

The main purpose of this therapy is to enhance the quality of life of the participants promoting an active lifestyle and quality of life, adherence a healthy nutritional habits and a healthy weight loss.

Our focus will be on teaching strategies to maintain a healthy life style behaviors after therapy, our protocol is in agreement with public health field in this way.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: August 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age from 30 to 50 years and body mass index (BMI) between 30 and 39.9 Kg/m2

Exclusion Criteria:

• Musculoskeletal limitations preventing the practice of physical exercise, other metabolic or endocrine diseases, identified genetic diseases, pregnancy, previous drug utilization and excessive chronic alcohol consumption

Related Conditions & MeSH terms

• Metabolic Diseases
• Obesity

Intervention

Behavioral:
• Interdisciplinary Therapy
The nutrition intervention will consist of group meetings and prescription of individual diets. Participants will have dietary lessons, with information related to the improvement of food consumption and nutritional quality. Exercise program will be focused on improving activity habits, leading to increased energy expenditure. They will undergo training sessions containing aerobic and resistance training. In Psychological program, participants will be monitored in the support group and, if necessary, individual psychological therapy is recommended. The sessions will discuss common psychological aspects commonly associated with obesity (depression, anxiety, stress, family problems, body image, eating disorders and others). The physiotherapy interventions aim to increase functional capacity.

Locations

Country	Name	City	State
Brazil	GEO - Obesity Study Group	Santos	Sao Paulo

Sponsors (4)

Lead Sponsor	Collaborator
Federal University of São Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordination for the Improvement of Higher Education Personnel, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Carvalho-Ferreira JP, Cipullo MA, Caranti DA, Masquio DC, Andrade-Silva SG, Pisani LP, Dâmaso AR. Interdisciplinary lifestyle therapy improves binge eating symptoms and body image dissatisfaction in Brazilian obese adults. Trends Psychiatry Psychother. 2012;34(4):223-33. — View Citation

Jamar G, Pisani LP, Medeiros A, Oyama LM, Masquio DC, Colantonio E, Garcia S, Sanches RB, dos Santos Moraes A, Belote C, Caranti DA. Effect of Fat Intake on the Inflammatory Process and Cardiometabolic Risk in Obesity After Interdisciplinary Therapy. Horm Metab Res. 2016 Feb;48(2):106-11. doi: 10.1055/s-0035-1548871. Epub 2015 Sep 15. — View Citation

Jamar G, Pisani LP, Oyama LM, Belote C, Masquio DC, Furuya VA, Carvalho-Ferreira JP, Andrade-Silva SG, Dâmaso AR, Caranti DA. Is the neck circumference an emergent predictor for inflammatory status in obese adults? Int J Clin Pract. 2013 Mar;67(3):217-24. doi: 10.1111/ijcp.12041. — View Citation

Moraes Ados S, Pisani LP, Corgosinho FC, Carvalho LO, Masquio DC, Jamar G, Sanches RB, Oyama LM, Dâmaso AR, Belote C, Caranti DA. The role of leptinemia state as a mediator of inflammation in obese adults. Horm Metab Res. 2013 Aug;45(8):605-10. doi: 10.1055/s-0033-1343450. Epub 2013 May 13. — View Citation

Sanches RB, Andrade-Silva SG, Rossi S, Fidalgo JPN, Moraes AS, Jamar GGQ, Colantonio E, Botero JP, dos Santos RVT, Caranti DA. Body composition and aerobic fitness in obese women: beneficial effects of interdisciplinary therapy. Brazilian Journal of Physical Activity and Health 18(3):354-362, 2013

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass	Body Mass (kg)	one year
Primary	Physical Activity	Quadrimensional accelerometer	one year
Secondary	Total Cholesterol.	Blood lipid fraction (mg/dL) after 12h overnight fasting.	one year
Secondary	High Density Lipoprotein - Cholesterol	HDL-c; Blood lipid fraction (mg/dL) after 12h overnight fasting.	one year
Secondary	Triglycerides	Blood lipid fraction (mg/dL) after 12h overnight fasting.	one year
Secondary	Glucose levels.	Glucose levels (mg/dL) after 12h overnight fasting.	one year
Secondary	Waist circumference	Anthropometric measure (cm)	one year
Secondary	Blood Pressure	Systolic and Diastolic Blood pressure (mmHg)	one year
Secondary	Improvement in Quality of Life	WHO - Quality of life Brief Questionnaire	One year
Secondary	Cardiorespiratory parameters	Maximal ergometer test. Maximal oxygen uptake.	One year
Secondary	Resting Metabolic Rate	Indirect calorimetry test (kcal/day)	One year
Secondary	Psychological Parameters - Anxiety	Anxiety, Beck´s Anxiety Inventory Questionnaire (Score)	one year
Secondary	Psychological Parameters - Depression	Depression; Beck´s Depression Inventory Questionnaire (Score)	one year
Secondary	Physiotherapy parameters	Functional capacity - Health Assessment Questionnaire (Score)	one year
Secondary	Nutritional parameters	Macronutrient, micronutrient and calorie intakes	one year
Secondary	Inflammatory markers	adipokines status	one year