ObesityPhase 4NCT01501721
Anthropometric Changes Associated With Home-based Exercise Among School Cooks
A Phase 4 study testing Exercise and Diet in people with Obesity, run by Rio de Janeiro State University.
Trial summary
Objective: This study aimed to characterize the food intake and energy expenditure of school cooks and to evaluate the anthropometric and metabolic changes that occurred after a low-volume home-based exercise program. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Mar 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Of the 36 public schools spread over five different areas, we selected 20 schools from three areas with similar demographic and socio-economic profiles.
Who cannot join
- School cooks who were pregnant or breastfeeding
About this study
Official title: Anthropometric and Metabolic Changes Associated With a Low-volume Home-based Exercise Program
Objective: This study aimed to characterize the food intake and energy expenditure of school cooks and to evaluate the anthropometric and metabolic changes that occurred after a low-volume home-based exercise program.
Methods: A randomized clinical trial in the city of Niteroi, Rio de Janeiro, Brazil, was conducted during the school year of 2007. The trial had a factorial design based on two different interventions: 1) nutritional counseling and 2) home-based exercise. The nutritional intervention was focused on decreasing the amount of sugar used in school meals by the cooks as well as decreasing their own sugar intake. The exercise program consisted of stretching and aerobic exercises that could be practiced at home, at least three times per week (40 minutes per session), with a low-to-moderate intensity.
Read the detailed description
A randomized clinical trial in the city of Niteroi, Rio de Janeiro, Brazil, was conducted during the school year of 2007 (March to December 2007). The trial had a factorial design based on two different interventions: 1) nutritional counseling and 2) home-based exercise. The present study focused on the effects of exercise intervention.
Of the 36 public schools spread over five different areas, we selected 20 schools from three areas with similar demographic and socio-economic profiles. Because of the small number of male cooks (n=5), we included only women who were neither pregnant nor breastfeeding. Cooks on sick leave or those working in other capacities were excluded. A total of 101 cooks were eligible, and six refused to participate in the study.
All participants received information about the goals of the study and signed a document indicating informed consent. The study was approved by the institutional review board of the State University of Rio de Janeiro.
School cooks enrolled in the present study were public servants and work in periods of eight hours, five days per week, in three different shifts (morning, afternoon and night). They are responsible to prepare all meals served at school and cleaning up, and schools do not have any machine to help them to perform their tasks. They eat at least one meal at school.
Sample size As previously reported13), the sample size was calculated assuming an individual reduction of 10% in sugar consumption (3.4 grams) with a power of 80% and a 5% significance level. Anticipating a rate of participation agreement around 80%, the total sample size was estimated to be 80 school cooks. For this purpose, 20 schools employing a total of 130 school cooks were randomized.
Intervention Nutritional and exercise counseling were given during the school year of 2007 (eight months). The nutritional counseling group received information focused on decreasing the amount of sugar used in school meals, as well as their own sugar intake. They participated in three nutritional education meetings regarding sugar intake and food label. All activities were realized at school and required about 20 minutes. In addition, they participated in a contest to create reduced-sugar recipes and banners, and magnets promoting the reduction of sugar intake were also provided. All school cooks, from both the control and nutritional counseling groups, participated in three discussion sessions about healthy eating.
The exercise intervention group received received a booklet on physical exercises, consisted of stretching and aerobic exercises that could be practiced at home at least three times per week for 40 minutes (per session) at low-to-moderate intensity (available at www.nebin.org). The exercise sessions were divided into three parts: 1) A warm-up routine consisting of gentle body movement and stretching exercises (5 minutes); 2) An aerobic cycle performed in a circuit with continuous movements involving large arm and leg muscles, as well as exercises using a ball, ropes, stair climbing, and standing up from a chair (balls and ropes were given to the participants) (30 minutes); and 3) a cool-down period, in which the same initial stretching exercises were performed (5 minutes). The participants were encouraged to engage in exercise of low-to-moderate intensity with low impact at least three times a week during the eight months. In the first week, women were advised to perform only a 20-minute session, increasing gradually (10 minutes/session/week) up to 40 minutes per session. Each session comprised activities with balls, ropes, stairs and chair. Additionally, they were advised to reduce the exercise intensity if they felt any discomfort (e.g., if they were experiencing breathlessness or muscle aches). School cooks allocated to control group received only general information for physical activity and did not received the booklet.
Measurements The anthropometric variables were collected at three different times (baseline, 4 and 8 months), while individual food intake, based on a previously validated food frequency questionnaire14), and fasting blood samples were collected at baseline and after 8 months.
Height was measured to the nearest 0.5 cm with a wall-mounted stadiometer, and body weight was measured using the same calibrated digital scale (Tanita, BC 533 Inner Scan) for all participants. Circumference measurements were taken at the largest girth of the hip and smallest girth of the waist. All anthropometric measurements were performed according to standard techniques15).
Blood samples were collected in the morning after 10 hours of fasting. Plasma lipids and glucose were measured using GoldAnalisa kits. The LDL and VLDL cholesterol concentrations were calculated according to the Friedewald equation16) based on the triacylglycerol measurements.
Physical activity energy expenditure at baseline was evaluated in a sub-sample of 30 participants using an accelerometer (Actical® physical activity monitor, Mini Mitter, Bend, OR, USA). The accelerometer was programmed according to the manufacturer's instructions by entering the height, weight, age and sex of each subject. The subjects were instructed to place the accelerometers at their waists and wear them continuously for two consecutive days, except during activities in which contact with water could occur (e.g., during a bath).
Data analysis The characteristics of school cooks were expressed as means with standard deviations, and we compared the two intervention groups at baseline by using Student's t-test. The effects of nutritional counselling and home-based exercise on weight and circumference were evaluated through repeated random regression (RRR) analysis using PROC MIXED in SAS (version 9.1; SAS Institute Inc, Cary, NC). The analysis for the effects of exercise intervention was adjusted for dietary intervention while the analysis for the effects of nutritional counselling was adjusted for exercise intervention. The RRR is an intention-to-treat analysis because it includes all observations of each one of the subjects regardless of loss to follow-up or complies with instructions. The term of interest was treatment X time interaction, which estimates the rate of change in the outcomes over time. Residual plots of all models were examined, and their distribution did not show major deviations from regression assumptions. Changes in plasma lipids and glucose (samples of which were taken twice) between the groups were determined by Student's t-test.
- Conditions
- Obesity
- Being tested
- Exercise, Diet
- Keywords
- prevention, workers, clinical trials, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Home-based exercise group
Home-based exercise program
DietBehavioural
Also called Diet group
Nutritional counseling aiming to reduce suggar intake
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Home-based exercise program Receives: Behavioral: Exercise |
| Nutritional counseling | Experimental | Nutrition counseling aiming to reduce suggar intake Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline for weight at 4 and 8 months of follow-up
Body weight was measured using the same calibrated digital scale (Tanita, BC 533 Inner Scan) for all participants
Measured: Baseline, 4 and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Felippe Felix Mediano, Rio de Janeiro State University
- Investigators
- Mauro Mediano, PhD, Principal investigator, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501721
- Sponsor's protocol ID
- CNPq474135/2006-3
- Status last verified
- Dec 2011
- First submitted
- 14 Dec 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthropometric and Metabolic Changes Associated With a Low-volume Home-based Exercise Program
- ClinicalTrials.gov ID
- NCT01501721
- Acronym / sponsor ID
- CNPq474135/2006-3
- Conditions
- Obesity
- Keywords
- prevention, workers, clinical trials, obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: This study aimed to characterize the food intake and energy expenditure of school cooks and to evaluate the anthropometric and metabolic changes that occurred after a low-volume home-based exercise program.
Methods: A randomized clinical trial in the city of Niteroi, Rio de Janeiro, Brazil, was conducted during the school year of 2007. The trial had a factorial design based on two different interventions: 1) nutritional counseling and 2) home-based exercise. The nutritional intervention was focused on decreasing the amount of sugar used in school meals by the cooks as well as decreasing their own sugar intake. The exercise program consisted of stretching and aerobic exercises that could be practiced at home, at least three times per week (40 minutes per session), with a low-to-moderate intensity.
Detailed description
A randomized clinical trial in the city of Niteroi, Rio de Janeiro, Brazil, was conducted during the school year of 2007 (March to December 2007). The trial had a factorial design based on two different interventions: 1) nutritional counseling and 2) home-based exercise. The present study focused on the effects of exercise intervention.
Of the 36 public schools spread over five different areas, we selected 20 schools from three areas with similar demographic and socio-economic profiles. Because of the small number of male cooks (n=5), we included only women who were neither pregnant nor breastfeeding. Cooks on sick leave or those working in other capacities were excluded. A total of 101 cooks were eligible, and six refused to participate in the study.
All participants received information about the goals of the study and signed a document indicating informed consent. The study was approved by the institutional review board of the State University of Rio de Janeiro.
School cooks enrolled in the present study were public servants and work in periods of eight hours, five days per week, in three different shifts (morning, afternoon and night). They are responsible to prepare all meals served at school and cleaning up, and schools do not have any machine to help them to perform their tasks. They eat at least one meal at school.
Sample size As previously reported13), the sample size was calculated assuming an individual reduction of 10% in sugar consumption (3.4 grams) with a power of 80% and a 5% significance level. Anticipating a rate of participation agreement around 80%, the total sample size was estimated to be 80 school cooks. For this purpose, 20 schools employing a total of 130 school cooks were randomized.
Intervention Nutritional and exercise counseling were given during the school year of 2007 (eight months). The nutritional counseling group received information focused on decreasing the amount of sugar used in school meals, as well as their own sugar intake. They participated in three nutritional education meetings regarding sugar intake and food label. All activities were realized at school and required about 20 minutes. In addition, they participated in a contest to create reduced-sugar recipes and banners, and magnets promoting the reduction of sugar intake were also provided. All school cooks, from both the control and nutritional counseling groups, participated in three discussion sessions about healthy eating.
The exercise intervention group received received a booklet on physical exercises, consisted of stretching and aerobic exercises that could be practiced at home at least three times per week for 40 minutes (per session) at low-to-moderate intensity (available at www.nebin.org). The exercise sessions were divided into three parts: 1) A warm-up routine consisting of gentle body movement and stretching exercises (5 minutes); 2) An aerobic cycle performed in a circuit with continuous movements involving large arm and leg muscles, as well as exercises using a ball, ropes, stair climbing, and standing up from a chair (balls and ropes were given to the participants) (30 minutes); and 3) a cool-down period, in which the same initial stretching exercises were performed (5 minutes). The participants were encouraged to engage in exercise of low-to-moderate intensity with low impact at least three times a week during the eight months. In the first week, women were advised to perform only a 20-minute session, increasing gradually (10 minutes/session/week) up to 40 minutes per session. Each session comprised activities with balls, ropes, stairs and chair. Additionally, they were advised to reduce the exercise intensity if they felt any discomfort (e.g., if they were experiencing breathlessness or muscle aches). School cooks allocated to control group received only general information for physical activity and did not received the booklet.
Measurements The anthropometric variables were collected at three different times (baseline, 4 and 8 months), while individual food intake, based on a previously validated food frequency questionnaire14), and fasting blood samples were collected at baseline and after 8 months.
Height was measured to the nearest 0.5 cm with a wall-mounted stadiometer, and body weight was measured using the same calibrated digital scale (Tanita, BC 533 Inner Scan) for all participants. Circumference measurements were taken at the largest girth of the hip and smallest girth of the waist. All anthropometric measurements were performed according to standard techniques15).
Blood samples were collected in the morning after 10 hours of fasting. Plasma lipids and glucose were measured using GoldAnalisa kits. The LDL and VLDL cholesterol concentrations were calculated according to the Friedewald equation16) based on the triacylglycerol measurements.
Physical activity energy expenditure at baseline was evaluated in a sub-sample of 30 participants using an accelerometer (Actical® physical activity monitor, Mini Mitter, Bend, OR, USA). The accelerometer was programmed according to the manufacturer's instructions by entering the height, weight, age and sex of each subject. The subjects were instructed to place the accelerometers at their waists and wear them continuously for two consecutive days, except during activities in which contact with water could occur (e.g., during a bath).
Data analysis The characteristics of school cooks were expressed as means with standard deviations, and we compared the two intervention groups at baseline by using Student's t-test. The effects of nutritional counselling and home-based exercise on weight and circumference were evaluated through repeated random regression (RRR) analysis using PROC MIXED in SAS (version 9.1; SAS Institute Inc, Cary, NC). The analysis for the effects of exercise intervention was adjusted for dietary intervention while the analysis for the effects of nutritional counselling was adjusted for exercise intervention. The RRR is an intention-to-treat analysis because it includes all observations of each one of the subjects regardless of loss to follow-up or complies with instructions. The term of interest was treatment X time interaction, which estimates the rate of change in the outcomes over time. Residual plots of all models were examined, and their distribution did not show major deviations from regression assumptions. Changes in plasma lipids and glucose (samples of which were taken twice) between the groups were determined by Student's t-test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseHome-based exercise program |
| Nutritional counseling | Experimental | Behavioral: DietNutrition counseling aiming to reduce suggar intake |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Of the 36 public schools spread over five different areas, we selected 20 schools from three areas with similar demographic and socio-economic profiles.
Key exclusion criteria (1 listed)
- School cooks who were pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Home-based exercise groupHome-based exercise program | Behavioural | Exercise |
| DietAlso: Diet groupNutritional counseling aiming to reduce suggar intake | Behavioural | Nutritional counseling |
Primary outcome
Change from baseline for weight at 4 and 8 months of follow-up
Time frame: Baseline, 4 and 8 months
Body weight was measured using the same calibrated digital scale (Tanita, BC 533 Inner Scan) for all participants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro Mediano, PhD principal investigator
Rio de Janeiro State University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exercise and Diet in people with Obesity, run by Rio de Janeiro State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline for weight at 4 and 8 months of follow-up (time frame: Baseline, 4 and 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2011.