Childhood ObesityNCT01539070
Intervention for the Prevention of Obesity in Preschool
A study testing Eating and physical activity counseling in people with Childhood Obesity, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
The purpose of this study is to develop, implement and evaluate an intervention focused to change feeding practices and patterns of physical activity of preschool children through providing motivational counseling to the mother. Read more about this study
- Who is it for?
- Ages 24 to 59 months
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Eating and physical activity counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 2 and 4 years and 11 months of age at the beginning of the study.
- Overweight children, defined as a BMI score of z > = 1.5 and < +3 based on the WHO standards.
- The children's parents accept participation in the study.
Who cannot join
- Families who plan on changing their address during the study.
- Families whose doctor considers them to be inappropriate for participation in the intervention, as with emotional or mental alterations.
- Children who require a special diet for medical reasons or children with limited motor functioning.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Epidemiology and Health Services Research Unit, Coordination of Health Research. Mexican Institute of Social Security, Mexico, D.F.
Mexico City, Mexico City, 06720
About this study
Official title: Design and Feasibility of a Clinical-based Intervention to Prevent Obesity in Preschool Children
The purpose of this study is to develop, implement and evaluate an intervention focused to change feeding practices and patterns of physical activity of preschool children through providing motivational counseling to the mother. The aim is to prevent obesity in children aged 2 to 4 years 11 months with risk of overweight or with overweight.
Read the detailed description
Obesity has a multi-causal origin in which participate, in a similar way, the individual behavior and family and community contexts and the social environment.
Participation of primary care services is key to solve the problem. These services have the possibility to detect timely children with high body mass index, and to promote behavior to improve feeding practices and physical activity in both, the child and his family.
The study is divided in two stages:
- Design of the intervention. The researchers will use qualitative methods to evaluate feeding practices, physical activity and the environment in which such behaviors are generated. In a similar way the care provided by health professionals to overweight and obese children it will be evaluated; this includes the perception that health providers have about this problem. The information will allow identifying risk behavior and healthy behavior, facilitators and obstacles to receive care. The results will serve to define the contents of the intervention.
- Intervention: The study will take place in four family medicine clinics belonging to the Mexican Institute of Social Security. Two clinics will receive the intervention and two will serve as control. In each clinic, fifty children and their mothers will be recruited. At the intervention clinics, the group of mothers will participate in seven weekly sessions and in two individual sessions at 3 and 6 months after the group sessions finish. During the sessions, the researchers will motivate the mothers to change feeding practices and encourage physical exercise of the children and family, this will improve the chance for their children for healthy growing. The control group will receive the usual care that consists only in the recommendations that the family doctor provides.
The evaluation of the study comprise feasibility and acceptability of the intervention and its effect in the behavior of the mothers in terms of changing feeding practices and practicing physical exercise.
- Conditions
- Childhood Obesity
- Being tested
- Eating and physical activity counseling
- Keywords
- Nutritional intervention, Childhood obesity, Physical activity, Feeding practices
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating and physical activity counselingBehavioural
Also called Nutritional intervention
The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.
There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Eating and physical activity counseling | Experimental | Participants randomized to intervention received a 6 week curriculum focused on obesity awareness and prevention. A trained nutritionist led diet, healthy growth and physical activity workshops, while a health educator led workshops on instilling healthy habits and routines in childhood. The nurse provided child care and developed relevant games and activities for children while parents attended the workshops. Receives: Behavioral: Eating and physical activity counseling |
| Usual care | No intervention | According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment
We asked parents about the average number of servings in the week or month the child consumed each food. We constructed grouped diet variables corresponding to food categories : sweet snacks (sugar-sweetened dairy, sugary cereal, cookies, sweet bread, cake, packaged pastries ], caramel pops, candies and chocolates); fast food (hamburgers, pizza, hot dogs, quesadillas, fried tacos, French fries); savory snacks (packaged snack foods, corn or potato chips); fruit (orange, mango, papaya, watermelon, grapes, apple, banana); vegetables (chard, broccoli, jitomate [tomato], nopales [cactus], chayote [squash], spinach, lettuce, zucchini, carrot); sugar-sweetened beverages (soda, flavored milk, homemade [agua fresca] and packaged fruit drinks); and added sugar in beverages (teaspoons sugar or sweet flavoring added to milk, coffee, tea, or fruit juice).
Measured: 0, 3 months
Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment
Staff assisted parents in reporting the average time the participating child spent in pre-specified active and sedentary activities during the week and on weekends. For each of the pre-specified activities parents reported time spent in open-ended response format. From these responses we derived total hours/week of physical activity composed of active play (e.g. running, jumping, walking, playing ball, playing in the park, biking, swimming, dancing), as well as total hours/week of screen time, composed of television, DVD/video, and video and computer games.
Measured: 0, 3 months
Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment
In order to calculate children's BMI and age and sex specific BMI z-scores at baseline and 3 month follow-up, study staff assessed child's height in meters and weight in kilograms. BMI was calculated as weight in kilograms divided by the square of height in meters.
Measured: 0, 3 month
Secondary outcomes (1)
Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group
We assessed the compliance with the study through attendiance appointments for assessing diet and physical activity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Hospital Infantil de Mexico Federico Gomez, Harvard Pilgrim Health Care, Fogarty International Center of the National Institute of Health, Inter-American Development Bank, Instituto Nacional de Salud Publica, Mexico, University of Guelph
- Responsible party
- Principal investigator, Gloria Oliva Martinez Andrade, Coordinación de Investigación en Salud, Mexico
- Investigators
- Gloria Martínez Andrade, Master, Principal investigator, Instituto Mexicano del Seguro SocialRicardo Pérez Cuevas, Doctor, Study director, Inter-American Development BankElsie Taveras, Doctor, Study director, Harvard Pilgrim Health CareMatt Gillman, Doctor, Study chair, Harvard Pilgrim Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539070
- Sponsor's protocol ID
- 2009-785-120
- Other IDs
- HIM/2010/025, 1R03TW008708
- Status last verified
- Mar 2014
- First submitted
- 14 Feb 2012
- Last updated
- 22 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Martinez-Andrade GO, Cespedes EM, Rifas-Shiman SL, Romero-Quechol G, Gonzalez-Unzaga MA, Benitez-Trejo MA, Flores-Huerta S, Horan C, Haines J, Taveras EM, Perez-Cuevas R, Gillman MW. Feasibility and impact of Creciendo Sanos, a clinic-based pilot intervention to prevent obesity among preschool children in Mexico City. BMC Pediatr. 2014 Mar 20;14:77. doi: 10.1186/1471-2431-14-77.
PubMed 24649831
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Feasibility of a Clinical-based Intervention to Prevent Obesity in Preschool Children
- ClinicalTrials.gov ID
- NCT01539070
- Acronym / sponsor ID
- 2009-785-120
- Conditions
- Childhood Obesity
- Keywords
- Nutritional intervention, Childhood obesity, Physical activity, Feeding practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Hospital Infantil de Mexico Federico Gomez, Harvard Pilgrim Health Care, Fogarty International Center of the National Institute of Health, Inter-American Development Bank, Instituto Nacional de Salud Publica, Mexico, University of Guelph
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Posted 22 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop, implement and evaluate an intervention focused to change feeding practices and patterns of physical activity of preschool children through providing motivational counseling to the mother. The aim is to prevent obesity in children aged 2 to 4 years 11 months with risk of overweight or with overweight.
Detailed description
Obesity has a multi-causal origin in which participate, in a similar way, the individual behavior and family and community contexts and the social environment.
Participation of primary care services is key to solve the problem. These services have the possibility to detect timely children with high body mass index, and to promote behavior to improve feeding practices and physical activity in both, the child and his family.
The study is divided in two stages:
- Design of the intervention. The researchers will use qualitative methods to evaluate feeding practices, physical activity and the environment in which such behaviors are generated. In a similar way the care provided by health professionals to overweight and obese children it will be evaluated; this includes the perception that health providers have about this problem. The information will allow identifying risk behavior and healthy behavior, facilitators and obstacles to receive care. The results will serve to define the contents of the intervention.
- Intervention: The study will take place in four family medicine clinics belonging to the Mexican Institute of Social Security. Two clinics will receive the intervention and two will serve as control. In each clinic, fifty children and their mothers will be recruited. At the intervention clinics, the group of mothers will participate in seven weekly sessions and in two individual sessions at 3 and 6 months after the group sessions finish. During the sessions, the researchers will motivate the mothers to change feeding practices and encourage physical exercise of the children and family, this will improve the chance for their children for healthy growing. The control group will receive the usual care that consists only in the recommendations that the family doctor provides.
The evaluation of the study comprise feasibility and acceptability of the intervention and its effect in the behavior of the mothers in terms of changing feeding practices and practicing physical exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eating and physical activity counseling | Experimental | Behavioral: Eating and physical activity counselingParticipants randomized to intervention received a 6 week curriculum focused on obesity awareness and prevention. A trained nutritionist led diet, healthy growth and physical activity workshops, while a health educator led workshops on instilling healthy habits and routines in childhood. The nurse provided child care and developed relevant games and activities for children while parents attended the workshops. |
| Usual care | No intervention | –According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation. |
Who may qualify
- Ages
- 24 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 2 and 4 years and 11 months of age at the beginning of the study.
- Overweight children, defined as a BMI score of z > = 1.5 and < +3 based on the WHO standards.
- The children's parents accept participation in the study.
Key exclusion criteria (3 listed)
- Families who plan on changing their address during the study.
- Families whose doctor considers them to be inappropriate for participation in the intervention, as with emotional or mental alterations.
- Children who require a special diet for medical reasons or children with limited motor functioning.
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 |
|---|---|---|
| Eating and physical activity counselingAlso: Nutritional interventionThe parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions. There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity. | Behavioural | Eating and physical activity counseling |
Primary outcome
Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment
Time frame: 0, 3 months
We asked parents about the average number of servings in the week or month the child consumed each food. We constructed grouped diet variables corresponding to food categories : sweet snacks (sugar-sweetened dairy, sugary cereal, cookies, sweet bread, cake, packaged pastries ], caramel pops, candies and chocolates); fast food (hamburgers, pizza, hot dogs, quesadillas, fried tacos, French fries); savory snacks (packaged snack foods, corn or potato chips); fruit (orange, mango, papaya, watermelon, grapes, apple, banana); vegetables (chard, broccoli, jitomate [tomato], nopales [cactus], chayote [squash], spinach, lettuce, zucchini, carrot); sugar-sweetened beverages (soda, flavored milk, homemade [agua fresca] and packaged fruit drinks); and added sugar in beverages (teaspoons sugar or sweet flavoring added to milk, coffee, tea, or fruit juice).
Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment
Time frame: 0, 3 months
Staff assisted parents in reporting the average time the participating child spent in pre-specified active and sedentary activities during the week and on weekends. For each of the pre-specified activities parents reported time spent in open-ended response format. From these responses we derived total hours/week of physical activity composed of active play (e.g. running, jumping, walking, playing ball, playing in the park, biking, swimming, dancing), as well as total hours/week of screen time, composed of television, DVD/video, and video and computer games.
Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment
Time frame: 0, 3 month
In order to calculate children's BMI and age and sex specific BMI z-scores at baseline and 3 month follow-up, study staff assessed child's height in meters and weight in kilograms. BMI was calculated as weight in kilograms divided by the square of height in meters.
1 secondary outcome
Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24649831Martinez-Andrade GO, Cespedes EM, Rifas-Shiman SL, Romero-Quechol G, Gonzalez-Unzaga MA, Benitez-Trejo MA, Flores-Huerta S, Horan C, Haines J, Taveras EM, Perez-Cuevas R, Gillman MW. Feasibility and impact of Creciendo Sanos, a clinic-based pilot intervention to prevent obesity among preschool children in Mexico City. BMC Pediatr. 2014 Mar 20;14:77. doi: 10.1186/1471-2431-14-77.
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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.
Gloria Martínez Andrade, Master principal investigator
Instituto Mexicano del Seguro Social
Ricardo Pérez Cuevas, Doctor study director
Inter-American Development Bank
Elsie Taveras, Doctor study director
Harvard Pilgrim Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eating and physical activity counseling in people with Childhood Obesity, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 3 inclusion and 3 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 22 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment (time frame: 0, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01539070, which also lists 1 linked publication.
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 22 Apr 2014.