Influence of a weight loss nutritional counselling program on cardiovascular diseease risk factors and the role of adipose tissue hormones on weight maintenance and regai

Not Applicable

• Conditions: Overweight. Obesity. Metabolic syndrome.; C23.888.144.699; C18.654.726.500; C18.452.394.968.500.570

• Registration Number: RBR-75n6gm
• Lead Sponsor: Hospital Universitário da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Adults (aged 20 to 59 years), both sexes, BMI of at least 25 kg/m2, who have read and signed the written informed consent. The subjects must attend at least 4 of the 5 group meetings.

Exclusion Criteria

Participation in other interventional studies; use of weight loss medication; use of illicit drugs; alcoholics; pregnancy or breastfeeding; upper and lower limb amputation; practice of high intensity physical activity; surgical procedures that may influence body weight 3 months prior and/or during the intervention and follow-up period; critical chronic and acute diseases that limit life expectancy in 6 months. Information regarding inclusion and exclusion criteria will be obtained from personal interview and medical records.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight loss after the intervention, assessed by weight difference between T0 and T1, based on the observation of any variation other than zero over the period.;Cardiometabolic profile improvement after the intervention, assessed by the variations in anthopometric (weight and waist circumference), body composition (bioeletric impedance) and biochemical (blood collection) parameters between T0 and T1, based on the observation of any variation other than zero over the period.;Weight regain 6 months after the end of the intervention, assessed by relative weight regain porcentage, calculated according the folowing equation: (weightT2-weightT1)/(weightT0-weightT1)*100, based on the observation of a variation of at least 10% over the period.;Change in leptin and adiponectin levels (assessed by blood collection and ELISA analysis) after the intervention, based on the observation of any variation other than zero between T0 and T1, and correlation with weight regain 6 months after the end of the intervention.

Secondary Outcome Measures

Name	Time	Method
Change in food consumption (assessed by 24-hour recall) and physical activity levels (assessed by Baecke questionnaire) after the intervention and 6 months after the end of the intervention, based on the observation of any change other than zero between T0 and T1 and between T1 and T2 periods.