Bariatric Surgery Candidate
Conditions
Keywords
Bariatric Surgery, Sleep, Chronotype
Brief summary
The present study has a prospective, longitudinal and observational character, will be performed with patients attending a private clinic specialized in the treatment of obesity and bariatric surgery. Patients to be analyzed should have a medical indication for bariatric surgery.
Detailed description
The patients will be selected for ten months and will be monitored for 12 months there are preoperative period, 3 months, 6 months and 12 months after surgery. Anthropometrical evaluation, biochemistry, polysomnography and sleep questionnaire (Epworth and Psqi) and midpoint sleep questionnaires will be performed to classify the chronotype for sleep pattern evaluation.
Interventions
None listed
Sponsors
Federal University of Uberlandia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Inclusion criteria
* Agree to participate in the study and sign the Informed Consent Form (EHIC) * Patients submitted to By-pass or Sleeve bariatric surgery or Endossleve * Patients with BMI above 35 kg / m². * Over the age of 18 and up to 60 years.
Exclusion criteria
* Failure to provide the information necessary for the development of the study. * Patients undergo revisional surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Parameters - Triglycerides (mg/dl) | Baseline and 6 months | Metabolic parameters will be evaluated using Triglycerides (mg/dl) |
| Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR) | Baseline and 6 months | Values of metabolic parameters will be evaluated using Homeostasis model assessment for beta-cell function (HOMA - IR) according to the standard assessment measurement in mg/dl. Higher values reflect worse insulin resistance |
| Metabolic Parameters - Cholesterol (mg/dl) | Baseline and 6 months | Metabolic parameters will be evaluated using Cholesterol (mg/dl) |
| Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl) | Baseline and 6 months | Metabolic parameters will be evaluated using High density lipoprotein cholesterol (HDL - mg/dl) |
| Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl) | Baseline and 6 months | Metabolic parameters will be evaluated using low density lipoprotein cholesterol (LDL -mg/dl) |
| Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl) | Baseline and 6 months | Metabolic parameters will be evaluated using Very low density lipoprotein cholesterol (VLDL - mg/dl) |
| Weight in Kg | Baseline, 3 and 6 months | Anthropometric assessment will be evaluated using weight (kg). |
| BMI in Kg/m² | Baseline, 3 and 6 months | Anthropometric assessment will be evaluated using BMI (kg/m²). |
| Waist Circumference in Centimeters (cm) | Baseline, 3 and 6 months | Anthropometric assessment will be evaluated using waist circumference (cm) |
| Hip Circumference in Centimeters (cm) | Baseline, 3 and 6 months | Anthropometric assessment will be evaluated using hip circumference (cm) |
| Neck Circumference in Centimeters (cm) | Baseline, 3 and 6 months | Anthropometric assessment will be evaluated using neck circumference (cm) |
| Metabolic Parameters - Fasting Glucose (mg/dl) | Baseline and 6 months | Metabolic parameters will be evaluated using fasting glucose (mg/dl) |
| Metabolic Parameters - Insulin (mg/dl) | Baseline and 6 months | Metabolic parameters will be evaluated using insulin (mg/dl) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food Consumption - Carbohydrate (Grams/Day) | Baseline, 3 and 6 months | The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies). |
| Food Consumption - Total Fat (Grams/Day) | Baseline, 3 and 6 months | The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies). |
| Food Consumption - Polyunsaturated Fat (Grams/Day) | Baseline, 3 and 6 months | The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies). |
| Food Consumption - Monounsaturated Fat (Grams/Day) | Baseline, 3 and 6 months | The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies). |
| Food Consumption - Calories (Grams/Day) | Baseline, 3 and 6 months | The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies). |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Small SJL Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (80%) or Sleeve (20%), female (80%) | 60 |
| Large SJL Patients who underwent bariatric surgery - Roux-en-Y gastric bypass (79%) or Sleeve (21%), female (74%) | 62 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
Baseline characteristics
| Characteristic | Total | Small SJL | Large SJL |
|---|---|---|---|
| Age, Continuous | 33 years | 33.5 years | 33 years |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 94 Participants | 48 Participants | 46 Participants |
| Sex: Female, Male Male | 28 Participants | 12 Participants | 16 Participants |
| Social jetlag exposure | 67 Minutes | 67 Minutes | 67 Minutes |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 122 |
| other Total, other adverse events | 0 / 122 |
| serious Total, serious adverse events | 0 / 122 |
Outcome results
Primary
BMI in Kg/m²
Anthropometric assessment will be evaluated using BMI (kg/m²).
Time frame: Baseline, 3 and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of BMI in the preoperative evaluation and in the third and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | BMI in Kg/m² | Baseline | 40.8 Kg/m² | Standard Error 0.4 |
| Small SJL | BMI in Kg/m² | 3 months | 32.9 Kg/m² | Standard Error 0.4 |
| Small SJL | BMI in Kg/m² | 6 months | 28.7 Kg/m² | Standard Error 0.4 |
| Large SJL | BMI in Kg/m² | Baseline | 41.8 Kg/m² | Standard Error 0.8 |
| Large SJL | BMI in Kg/m² | 3 months | 33.6 Kg/m² | Standard Error 0.7 |
| Large SJL | BMI in Kg/m² | 6 months | 30.2 Kg/m² | Standard Error 0.7 |
Primary
Hip Circumference in Centimeters (cm)
Anthropometric assessment will be evaluated using hip circumference (cm)
Time frame: Baseline, 3 and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of hip circumference in the preoperative evaluation and in the third and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Hip Circumference in Centimeters (cm) | Baseline | 128.9 Centimeters | Standard Error 1.1 |
| Small SJL | Hip Circumference in Centimeters (cm) | 3 months | 114.9 Centimeters | Standard Error 1.1 |
| Small SJL | Hip Circumference in Centimeters (cm) | 6 months | 105.8 Centimeters | Standard Error 1 |
| Large SJL | Hip Circumference in Centimeters (cm) | Baseline | 131.4 Centimeters | Standard Error 1.7 |
| Large SJL | Hip Circumference in Centimeters (cm) | 3 months | 117.8 Centimeters | Standard Error 1.7 |
| Large SJL | Hip Circumference in Centimeters (cm) | 6 months | 109.9 Centimeters | Standard Error 1.6 |
Primary
Metabolic Parameters - Cholesterol (mg/dl)
Metabolic parameters will be evaluated using Cholesterol (mg/dl)
Time frame: Baseline and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of cholesterol in the preoperative evaluation and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Metabolic Parameters - Cholesterol (mg/dl) | Baseline | 201.6 mg/dl | Standard Error 5.3 |
| Small SJL | Metabolic Parameters - Cholesterol (mg/dl) | 6 months | 157.0 mg/dl | Standard Error 4.2 |
| Large SJL | Metabolic Parameters - Cholesterol (mg/dl) | Baseline | 203.9 mg/dl | Standard Error 5.4 |
| Large SJL | Metabolic Parameters - Cholesterol (mg/dl) | 6 months | 159.5 mg/dl | Standard Error 4.6 |
Primary
Metabolic Parameters - Fasting Glucose (mg/dl)
Metabolic parameters will be evaluated using fasting glucose (mg/dl)
Time frame: Baseline and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of fasting glucose in the preoperative evaluation and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Metabolic Parameters - Fasting Glucose (mg/dl) | Baseline | 99.0 mg/dl | Standard Error 1.7 |
| Small SJL | Metabolic Parameters - Fasting Glucose (mg/dl) | 6 months | 84.5 mg/dl | Standard Error 1.1 |
| Large SJL | Metabolic Parameters - Fasting Glucose (mg/dl) | Baseline | 101.2 mg/dl | Standard Error 3.6 |
| Large SJL | Metabolic Parameters - Fasting Glucose (mg/dl) | 6 months | 83.3 mg/dl | Standard Error 0.8 |
Primary
Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl)
Metabolic parameters will be evaluated using High density lipoprotein cholesterol (HDL - mg/dl)
Time frame: Baseline and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of HDL in the preoperative evaluation and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl) | Baseline | 51.4 mg/dl | Standard Error 1.7 |
| Small SJL | Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl) | 6 months | 52.1 mg/dl | Standard Error 1.6 |
| Large SJL | Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl) | Baseline | 47.6 mg/dl | Standard Error 1.6 |
| Large SJL | Metabolic Parameters - High Density Lipoprotein Cholesterol (HDL - mg/dl) | 6 months | 47.1 mg/dl | Standard Error 1.5 |
Primary
Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR)
Values of metabolic parameters will be evaluated using Homeostasis model assessment for beta-cell function (HOMA - IR) according to the standard assessment measurement in mg/dl. Higher values reflect worse insulin resistance
Time frame: Baseline and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of HOMA IR in the preoperative evaluation and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR) | Baseline | 6.7 mg/dl | Standard Error 0.5 |
| Small SJL | Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR) | 6 months | 1.8 mg/dl | Standard Error 0.2 |
| Large SJL | Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR) | Baseline | 6.2 mg/dl | Standard Error 0.4 |
| Large SJL | Metabolic Parameters - Homeostasis Model Assessment for Beta-cell Function (HOMA - IR) | 6 months | 2.1 mg/dl | Standard Error 0.1 |
Primary
Metabolic Parameters - Insulin (mg/dl)
Metabolic parameters will be evaluated using insulin (mg/dl)
Time frame: Baseline and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of insulin in the preoperative evaluation and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Metabolic Parameters - Insulin (mg/dl) | Baseline | 27.0 mg/dl | Standard Error 2.1 |
| Small SJL | Metabolic Parameters - Insulin (mg/dl) | 6 months | 8.8 mg/dl | Standard Error 0.9 |
| Large SJL | Metabolic Parameters - Insulin (mg/dl) | Baseline | 25.2 mg/dl | Standard Error 1.6 |
| Large SJL | Metabolic Parameters - Insulin (mg/dl) | 6 months | 10.5 mg/dl | Standard Error 0.6 |
Primary
Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl)
Metabolic parameters will be evaluated using low density lipoprotein cholesterol (LDL -mg/dl)
Time frame: Baseline and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of LDL in the preoperative evaluation and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl) | Baseline | 118.0 mg/dl | Standard Error 4.4 |
| Small SJL | Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl) | 6 months | 86.0 mg/dl | Standard Error 3.5 |
| Large SJL | Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl) | Baseline | 119.8 mg/dl | Standard Error 4.3 |
| Large SJL | Metabolic Parameters - Low Density Lipoprotein Cholesterol (LDL - mg/dl) | 6 months | 92.9 mg/dl | Standard Error 3.8 |
Primary
Metabolic Parameters - Triglycerides (mg/dl)
Metabolic parameters will be evaluated using Triglycerides (mg/dl)
Time frame: Baseline and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of triglycerides in the preoperative evaluation and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Metabolic Parameters - Triglycerides (mg/dl) | Baseline | 162.9 mg/dl | Standard Error 10.6 |
| Small SJL | Metabolic Parameters - Triglycerides (mg/dl) | 6 months | 98.8 mg/dl | Standard Error 5.7 |
| Large SJL | Metabolic Parameters - Triglycerides (mg/dl) | Baseline | 162.3 mg/dl | Standard Error 9 |
| Large SJL | Metabolic Parameters - Triglycerides (mg/dl) | 6 months | 96.0 mg/dl | Standard Error 4.6 |
Primary
Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl)
Metabolic parameters will be evaluated using Very low density lipoprotein cholesterol (VLDL - mg/dl)
Time frame: Baseline and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of VLDL in the preoperative evaluation and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl) | Baseline | 32.2 mg/dl | Standard Error 2.6 |
| Small SJL | Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl) | 6 months | 19.3 mg/dl | Standard Error 0.9 |
| Large SJL | Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl) | Baseline | 36.4 mg/dl | Standard Error 2.9 |
| Large SJL | Metabolic Parameters - Very Low Density Lipoprotein Cholesterol (VLDL - mg/dl) | 6 months | 19.4 mg/dl | Standard Error 1.1 |
Primary
Neck Circumference in Centimeters (cm)
Anthropometric assessment will be evaluated using neck circumference (cm)
Time frame: Baseline, 3 and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of neck circumference in the preoperative evaluation and in the third and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Neck Circumference in Centimeters (cm) | 3 months | 36.0 Centimeters | Standard Error 0.4 |
| Small SJL | Neck Circumference in Centimeters (cm) | Baseline | 39.2 Centimeters | Standard Error 0.4 |
| Small SJL | Neck Circumference in Centimeters (cm) | 6 months | 34.4 Centimeters | Standard Error 0.3 |
| Large SJL | Neck Circumference in Centimeters (cm) | Baseline | 39.4 Centimeters | Standard Error 0.5 |
| Large SJL | Neck Circumference in Centimeters (cm) | 3 months | 36.3 Centimeters | Standard Error 0.4 |
| Large SJL | Neck Circumference in Centimeters (cm) | 6 months | 35.1 Centimeters | Standard Error 0.4 |
Primary
Waist Circumference in Centimeters (cm)
Anthropometric assessment will be evaluated using waist circumference (cm)
Time frame: Baseline, 3 and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of waist circumference in the preoperative evaluation and in the third and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Waist Circumference in Centimeters (cm) | 3 months | 94.1 Centimeters | Standard Error 1.2 |
| Small SJL | Waist Circumference in Centimeters (cm) | 6 months | 85.5 Centimeters | Standard Error 1.1 |
| Small SJL | Waist Circumference in Centimeters (cm) | Baseline | 109.3 Centimeters | Standard Error 1.4 |
| Large SJL | Waist Circumference in Centimeters (cm) | 3 months | 95.1 Centimeters | Standard Error 1.4 |
| Large SJL | Waist Circumference in Centimeters (cm) | 6 months | 88.4 Centimeters | Standard Error 1.4 |
| Large SJL | Waist Circumference in Centimeters (cm) | Baseline | 110.0 Centimeters | Standard Error 1.7 |
Primary
Weight in Kg
Anthropometric assessment will be evaluated using weight (kg).
Time frame: Baseline, 3 and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of weight in the preoperative evaluation and in the third and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Weight in Kg | Baseline | 111.4 Kg | Standard Error 2.1 |
| Small SJL | Weight in Kg | 3 months | 89.7 Kg | Standard Error 1.7 |
| Small SJL | Weight in Kg | 6 months | 77.5 Kg | Standard Error 1.5 |
| Large SJL | Weight in Kg | Baseline | 116.4 Kg | Standard Error 3.3 |
| Large SJL | Weight in Kg | 3 months | 93.5 Kg | Standard Error 2.7 |
| Large SJL | Weight in Kg | 6 months | 84.2 Kg | Standard Error 2.6 |
Secondary
Food Consumption - Calories (Grams/Day)
The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).
Time frame: Baseline, 3 and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of food consumption of calories in the preoperative evaluation and in the third and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Food Consumption - Calories (Grams/Day) | Baseline | 2185.0 grams/day | Standard Error 95.5 |
| Small SJL | Food Consumption - Calories (Grams/Day) | 3 months | 823.8 grams/day | Standard Error 32 |
| Small SJL | Food Consumption - Calories (Grams/Day) | 6 months | 937.7 grams/day | Standard Error 30.6 |
| Large SJL | Food Consumption - Calories (Grams/Day) | Baseline | 2565.6 grams/day | Standard Error 130 |
| Large SJL | Food Consumption - Calories (Grams/Day) | 3 months | 889.7 grams/day | Standard Error 34.2 |
| Large SJL | Food Consumption - Calories (Grams/Day) | 6 months | 1091.9 grams/day | Standard Error 39 |
Secondary
Food Consumption - Carbohydrate (Grams/Day)
The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).
Time frame: Baseline, 3 and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of food consumption of the carbohydrate in the preoperative evaluation and in the third and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Food Consumption - Carbohydrate (Grams/Day) | 3 months | 61 grams/day | Standard Error 3.1 |
| Small SJL | Food Consumption - Carbohydrate (Grams/Day) | 6 months | 68.8 grams/day | Standard Error 3.5 |
| Small SJL | Food Consumption - Carbohydrate (Grams/Day) | Baseline | 229.0 grams/day | Standard Error 9.4 |
| Large SJL | Food Consumption - Carbohydrate (Grams/Day) | 3 months | 70.7 grams/day | Standard Error 3.7 |
| Large SJL | Food Consumption - Carbohydrate (Grams/Day) | 6 months | 77.7 grams/day | Standard Error 3.8 |
| Large SJL | Food Consumption - Carbohydrate (Grams/Day) | Baseline | 261.4 grams/day | Standard Error 13.7 |
Secondary
Food Consumption - Monounsaturated Fat (Grams/Day)
The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).
Time frame: Baseline, 3 and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of food consumption of Monounsaturated fat in the preoperative evaluation and in the third and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Food Consumption - Monounsaturated Fat (Grams/Day) | Baseline | 30.1 grams/day | Standard Error 1.9 |
| Small SJL | Food Consumption - Monounsaturated Fat (Grams/Day) | 3 months | 10.0 grams/day | Standard Error 0.6 |
| Small SJL | Food Consumption - Monounsaturated Fat (Grams/Day) | 6 months | 12.8 grams/day | Standard Error 0.5 |
| Large SJL | Food Consumption - Monounsaturated Fat (Grams/Day) | Baseline | 34.5 grams/day | Standard Error 1.9 |
| Large SJL | Food Consumption - Monounsaturated Fat (Grams/Day) | 3 months | 10.2 grams/day | Standard Error 0.6 |
| Large SJL | Food Consumption - Monounsaturated Fat (Grams/Day) | 6 months | 15.6 grams/day | Standard Error 0.9 |
Secondary
Food Consumption - Polyunsaturated Fat (Grams/Day)
The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).
Time frame: Baseline, 3 and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of food consumption of Polyunsaturated fat in the preoperative evaluation and in the third and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Food Consumption - Polyunsaturated Fat (Grams/Day) | 3 months | 4.5 grams/day | Standard Error 0.2 |
| Small SJL | Food Consumption - Polyunsaturated Fat (Grams/Day) | Baseline | 12.9 grams/day | Standard Error 0.9 |
| Small SJL | Food Consumption - Polyunsaturated Fat (Grams/Day) | 6 months | 5.9 grams/day | Standard Error 0.3 |
| Large SJL | Food Consumption - Polyunsaturated Fat (Grams/Day) | Baseline | 15.9 grams/day | Standard Error 1.2 |
| Large SJL | Food Consumption - Polyunsaturated Fat (Grams/Day) | 3 months | 5.0 grams/day | Standard Error 0.3 |
| Large SJL | Food Consumption - Polyunsaturated Fat (Grams/Day) | 6 months | 7.8 grams/day | Standard Error 0.5 |
Secondary
Food Consumption - Total Fat (Grams/Day)
The food consumption was evaluated by two 24-h recalls at each evaluation moment (Baseline, third and sixth month), with one occurring on a weekday (applied in a private room with the interviewer and participant only) and the other one on the weekend (applied by phone, as done in previous studies).
Time frame: Baseline, 3 and 6 months
Population: Generalised estimating equations with gamma distribution and adjusted for possible confounding factors were used to examine the effect of SJL exposure level (large or small) between these factors on the evolution of food consumption of total fat in the preoperative evaluation and in the third and sixth months after the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Small SJL | Food Consumption - Total Fat (Grams/Day) | Baseline | 97.3 grams/day | Standard Error 5.6 |
| Small SJL | Food Consumption - Total Fat (Grams/Day) | 3 months | 32.2 grams/day | Standard Error 1.7 |
| Small SJL | Food Consumption - Total Fat (Grams/Day) | 6 months | 40.2 grams/day | Standard Error 1.7 |
| Large SJL | Food Consumption - Total Fat (Grams/Day) | Baseline | 116.5 grams/day | Standard Error 7.4 |
| Large SJL | Food Consumption - Total Fat (Grams/Day) | 3 months | 33.2 grams/day | Standard Error 1.9 |
| Large SJL | Food Consumption - Total Fat (Grams/Day) | 6 months | 49.5 grams/day | Standard Error 2.4 |