ObesityNCT01679938
A Child Care-based Obesity Prevention Intervention
A study testing primary obesity prevention in people with Obesity, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
Trial summary
The overall objective is to determine the impact of comprehensive, multifaceted, child care-based intervention to prevent obesity among children 2 through 5 years of age. The specific aims are: 1. Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- primary obesity prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteMexico
- Study dates
- May 2011to May 2013
- Phase
- Interventional
- 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 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- IMSS child care centers with at least 40 children aged 2-4 years
- Child care center director that is willing to participate in the study and agrees to be randomized to control or intervention conditions. Since the intervention is a primary prevention program, the program will be available to all children, aged 2 to 4 years, at the child care centers, regardless of their current weight status
- Children's parents who sign a consent form indicating their permission for their child to participate in the study and their willingness to participate in the measurement activities
Who cannot join
- Children with chronic conditions that limit ability to measure height and weight or substantially interfere with growth, physical activity, or dietary recommendations from the measurement activities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Obesity in Children: An Intervention Based on Child Care Centers Belonging to the Mexican Institute of Social Security
The overall objective is to determine the impact of comprehensive, multifaceted, child care-based intervention to prevent obesity among children 2 through 5 years of age. The specific aims are:
- To determine the extent to which the intervention, compared with the control condition, results in a smaller age-associated increase in body mass index (BMI) after a 6-month intervention (primary outcome) and a 1-year follow-up period among children.
- To determine the extent to which the intervention, compared with the control condition, reduces the proportion of children who are obese (BMI >95th percentile for age and sex).
- To determine the extent to which the intervention, compared with the control condition, results in:
- improved dietary, physical activity and television-viewing behaviors among children, specifically, reducing the consumption of sugar-sweetened beverages, high calorie/low nutrient-dense snack foods, and fast food, increasing active time, and reducing TV/video viewing time;
- improved home food and activity environment, specifically, decreasing availability of sugar-sweetened beverages and high calorie/low nutrient-dense snack foods, and increasing parental support for healthy eating and regular physical activity;
- improved child care center food and activity environment, specifically, increasing opportunities for healthy eating and physical activity, and increasing support and encouragement of children's behavior change by child care providers;
- To assess the feasibility and acceptability of the intervention among child care providers and families.
Read more
METHODS. The investigators will conduct a cluster-randomized controlled trial in 16 IMSS child care centers in Mexico City. The investigators will randomly assign 8 child care centers to the intervention condition and 8 to an assessment-only control condition.
Multifaceted intervention. The resulting intervention will involve four main components:
- Training of child care providers.
- Curriculum sessions for children.
- Family outreach activities.
- Maintenance activities. Outcome and process measurements. Age-associated BMI (child's), changes in child's key obesity-related behaviors, changes in the child's home food and activity environment, and changes in child care food and activity environment. At the intervention and control child care sites, changes from baseline to one year for all outcome variables will be measured.
Read the detailed description
Over the past 20 years, the prevalence of obesity in Mexico has increased dramatically among individuals across the lifespan, including even the youngest populations.National data from the Mexican Institute of Social Security (IMSS) population estimate that nearly 15% of children aged 2 to 5 years are obese as defined by World Health Organization criteria. Obesity among preschool-aged children is of serious public health concern due to its adverse effects on children's physical and psychosocial well-being,and its association with obesity risk in later childhood, adolescence, and young adulthood. Furthermore, because dietary and activity patterns have not been firmly established, early childhood represents a critical window for prevention.
Given the high number of preschool children enrolled in out-of-home child care in Mexico, important opportunities exist for developing child care-based obesity prevention interventions focused on promoting healthy activity and dietary behaviors among children. Child care centers provide an ideal setting for a multi-level, ecologic intervention that includes strategies aimed at environmental level changes within the child care center, as well as individual level behavior change among the children. In addition, child care-based interventions have the potential to reach out to the children's families to improve the child's home food and activity environment.
Setting and study population. There are 142 IMSS child care centers in Mexico City. To allow for adequate attention to details in the development of the intervention and evaluation protocol and to contain costs prior to broad dissemination of the program, the investigators will focus on 16 IMSS child care sites for this proposal, which together provide care for approximately 450 children aged 2 to 5 years. At each IMSS child care center a team consisting of a nutritionist, a nurse, an educator, and child care technicians provides the daily care and education programs for the children. This extensive personnel structure provides the ideal infrastructure for implementing the proposed multifaceted intervention.
Since the intervention is a primary prevention program, the investigators will make the program available to all children, aged 2 to 5 years, at the child care centers, regardless of their current weight status. Children with chronic conditions that limit ability to measure height and weight or substantially interfere with growth, physical activity, or dietary recommendations will be excluded.
Data analysis for outcome measures. Intent-to-treat analyses to compare study outcomes between the intervention and control groups at post-intervention and at 6-months follow-up will be used. To compare the difference the age-associated increase in body mass index (BMI) among intervention and control groups (Aim 1), the mixed effects model with group (child care center) as the clustering factor will be used, as recommended by several authoritative sources. Similar analyses to compare the difference in prevalence of overweight (Aim 2), in the children's weight-related behaviors (Aim 3a), in the children's home environment (Aim 3b), and in the environment of the child care center (Aim 3c) will be performed.
- Conditions
- Obesity
- Being tested
- primary obesity prevention
- Keywords
- obesity prevention, cluster-randomized controlled trial, preschool-aged children
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary obesity preventionBehavioural
- Training of child care providers.
- Curriculum sessions for children. Child care providers will facilitate 12 interactive education sessions that focus on key obesity-related behaviors.
- Family outreach activities. Child care providers and research staff will communicate behavior change messages to families through ten take-home activities focused on key obesity-related behaviors and through monthly family workshops at the child care center.
- Maintenance activities. Over the six months following the main intervention, research staff will conduct eight booster sessions for the children and one booster session for the family that will build upon activities and behavior change messages of the main intervention.
| Study group | Role | What they receive |
|---|---|---|
| primary obesity prevention | Experimental | The intervention will involve four main components:
1. Training of child care providers.
2. Curriculum sessions for children.
3. Family outreach activities.
4. Maintenance activities. Receives: Behavioral: primary obesity prevention |
| Control group | No intervention | For the control group, usual care will be provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's age-associated Body Mass Index
The investigators will measure standing height for all participants over the age of 3 years, and from 2-3 years when possible. For some participants between age 2 and 3 years requiring recumbent lengths, a recumbent board and the recumbent to standing correction factor recommended by the U.S. Centers for Disease Control and Prevention (0.8 cm)will be used.In all cases, BMI will be the ratio of weight (kg) to the square of standing height (m). Accepted definition of obese (BMI >95th percentile for age and sex) and overweight (BMI 85th - 95th percentile for age and sex)will be used. All height and weight measurements will be conducted in a private area at the child care sites.
Measured: Change from baseline (May 2011) at one year follow-up (November 2012)
Secondary outcomes (2)
Children's home environment
To assess the home food and nutrition environment, research staff will conduct in-person surveys with parents using items from the Healthy Home Survey. The Healthy Home Survey was designed to assess key aspects of the diet and activity home environment, including availability of foods, role modeling by parents of behaviors, and parental support for healthy behaviors.
Measured: Change from baseline at one year follow-up.
Children's key obesity-related behaviors.
Research staff will conduct brief, in-person surveys with parents to measure children's obesity-related behaviors. The in-person surveys will include questions about the children's behaviors and the children's home dietary and activity environment and will be conducted at the child care center when parents come to pick up their children.
Measured: Change from baseline at one year of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico, Instituto Mexicano del Seguro Social, Harvard Pilgrim Health Care
- Responsible party
- Principal investigator, Hortensia Reyes Morales, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Hortensia Reyes-Morales, DrSc, Principal investigator, Instituto Nacional de Salud Publica, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679938
- Sponsor's protocol ID
- SALUD-2009-01-114027
- Status last verified
- Aug 2018
- First submitted
- 24 Aug 2012
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rodriguez-Oliveros G, Haines J, Ortega-Altamirano D, Power E, Taveras EM, Gonzalez-Unzaga MA, Reyes-Morales H. Obesity determinants in Mexican preschool children: parental perceptions and practices related to feeding and physical activity. Arch Med Res. 2011 Aug;42(6):532-9. doi: 10.1016/j.arcmed.2011.10.006. Epub 2011 Oct 21.
PubMed 22019411
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Obesity in Children: An Intervention Based on Child Care Centers Belonging to the Mexican Institute of Social Security
- ClinicalTrials.gov ID
- NCT01679938
- Acronym / sponsor ID
- SALUD-2009-01-114027
- Conditions
- Obesity
- Keywords
- obesity prevention, cluster-randomized controlled trial, preschool-aged children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico, Instituto Mexicano del Seguro Social, Harvard Pilgrim Health Care
- Study start
- May 2011 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 6 Sep 2012 (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.
The overall objective is to determine the impact of comprehensive, multifaceted, child care-based intervention to prevent obesity among children 2 through 5 years of age. The specific aims are:
- To determine the extent to which the intervention, compared with the control condition, results in a smaller age-associated increase in body mass index (BMI) after a 6-month intervention (primary outcome) and a 1-year follow-up period among children.
- To determine the extent to which the intervention, compared with the control condition, reduces the proportion of children who are obese (BMI >95th percentile for age and sex).
- To determine the extent to which the intervention, compared with the control condition, results in:
- improved dietary, physical activity and television-viewing behaviors among children, specifically, reducing the consumption of sugar-sweetened beverages, high calorie/low nutrient-dense snack foods, and fast food, increasing active time, and reducing TV/video viewing time;
- improved home food and activity environment, specifically, decreasing availability of sugar-sweetened beverages and high calorie/low nutrient-dense snack foods, and increasing parental support for healthy eating and regular physical activity;
- improved child care center food and activity environment, specifically, increasing opportunities for healthy eating and physical activity, and increasing support and encouragement of children's behavior change by child care providers;
- To assess the feasibility and acceptability of the intervention among child care providers and families.
METHODS. The investigators will conduct a cluster-randomized controlled trial in 16 IMSS child care centers in Mexico City. The investigators will randomly assign 8 child care centers to the intervention condition and 8 to an assessment-only control condition.
Multifaceted intervention. The resulting intervention will involve four main components:
- Training of child care providers.
- Curriculum sessions for children.
- Family outreach activities.
- Maintenance activities. Outcome and process measurements. Age-associated BMI (child's), changes in child's key obesity-related behaviors, changes in the child's home food and activity environment, and changes in child care food and activity environment. At the intervention and control child care sites, changes from baseline to one year for all outcome variables will be measured.
Detailed description
Over the past 20 years, the prevalence of obesity in Mexico has increased dramatically among individuals across the lifespan, including even the youngest populations.National data from the Mexican Institute of Social Security (IMSS) population estimate that nearly 15% of children aged 2 to 5 years are obese as defined by World Health Organization criteria. Obesity among preschool-aged children is of serious public health concern due to its adverse effects on children's physical and psychosocial well-being,and its association with obesity risk in later childhood, adolescence, and young adulthood. Furthermore, because dietary and activity patterns have not been firmly established, early childhood represents a critical window for prevention.
Given the high number of preschool children enrolled in out-of-home child care in Mexico, important opportunities exist for developing child care-based obesity prevention interventions focused on promoting healthy activity and dietary behaviors among children. Child care centers provide an ideal setting for a multi-level, ecologic intervention that includes strategies aimed at environmental level changes within the child care center, as well as individual level behavior change among the children. In addition, child care-based interventions have the potential to reach out to the children's families to improve the child's home food and activity environment.
Setting and study population. There are 142 IMSS child care centers in Mexico City. To allow for adequate attention to details in the development of the intervention and evaluation protocol and to contain costs prior to broad dissemination of the program, the investigators will focus on 16 IMSS child care sites for this proposal, which together provide care for approximately 450 children aged 2 to 5 years. At each IMSS child care center a team consisting of a nutritionist, a nurse, an educator, and child care technicians provides the daily care and education programs for the children. This extensive personnel structure provides the ideal infrastructure for implementing the proposed multifaceted intervention.
Since the intervention is a primary prevention program, the investigators will make the program available to all children, aged 2 to 5 years, at the child care centers, regardless of their current weight status. Children with chronic conditions that limit ability to measure height and weight or substantially interfere with growth, physical activity, or dietary recommendations will be excluded.
Data analysis for outcome measures. Intent-to-treat analyses to compare study outcomes between the intervention and control groups at post-intervention and at 6-months follow-up will be used. To compare the difference the age-associated increase in body mass index (BMI) among intervention and control groups (Aim 1), the mixed effects model with group (child care center) as the clustering factor will be used, as recommended by several authoritative sources. Similar analyses to compare the difference in prevalence of overweight (Aim 2), in the children's weight-related behaviors (Aim 3a), in the children's home environment (Aim 3b), and in the environment of the child care center (Aim 3c) will be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary obesity prevention | Experimental | Behavioral: primary obesity preventionThe intervention will involve four main components: 1. Training of child care providers. 2. Curriculum sessions for children. 3. Family outreach activities. 4. Maintenance activities. |
| Control group | No intervention | –For the control group, usual care will be provided |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- IMSS child care centers with at least 40 children aged 2-4 years
- Child care center director that is willing to participate in the study and agrees to be randomized to control or intervention conditions. Since the intervention is a primary prevention program, the program will be available to all children, aged 2 to 4 years, at the child care centers, regardless of their current weight status
- Children's parents who sign a consent form indicating their permission for their child to participate in the study and their willingness to participate in the measurement activities
Key exclusion criteria (1 listed)
- Children with chronic conditions that limit ability to measure height and weight or substantially interfere with growth, physical activity, or dietary recommendations from the measurement activities
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 |
|---|---|---|
| primary obesity prevention1. Training of child care providers. 2. Curriculum sessions for children. Child care providers will facilitate 12 interactive education sessions that focus on key obesity-related behaviors. 3. Family outreach activities. Child care providers and research staff will communicate behavior change messages to families through ten take-home activities focused on key obesity-related behaviors and through monthly family workshops at the child care center. 4. Maintenance activities. Over the six months following the main intervention, research staff will conduct eight booster sessions for the children and one booster session for the family that will build upon activities and behavior change messages of the main intervention. | Behavioural | primary obesity prevention |
Primary outcome
Child's age-associated Body Mass Index
Time frame: Change from baseline (May 2011) at one year follow-up (November 2012)
The investigators will measure standing height for all participants over the age of 3 years, and from 2-3 years when possible. For some participants between age 2 and 3 years requiring recumbent lengths, a recumbent board and the recumbent to standing correction factor recommended by the U.S. Centers for Disease Control and Prevention (0.8 cm)will be used.In all cases, BMI will be the ratio of weight (kg) to the square of standing height (m). Accepted definition of obese (BMI >95th percentile for age and sex) and overweight (BMI 85th - 95th percentile for age and sex)will be used. All height and weight measurements will be conducted in a private area at the child care sites.
2 secondary outcomes
Children's home environment
Time frame: Change from baseline at one year follow-up.
Children's key obesity-related behaviors.
Time frame: Change from baseline at one year of follow-up.
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 21 Aug 2018.
- Results publication: PubMed 22019411Rodriguez-Oliveros G, Haines J, Ortega-Altamirano D, Power E, Taveras EM, Gonzalez-Unzaga MA, Reyes-Morales H. Obesity determinants in Mexican preschool children: parental perceptions and practices related to feeding and physical activity. Arch Med Res. 2011 Aug;42(6):532-9. doi: 10.1016/j.arcmed.2011.10.006. Epub 2011 Oct 21.
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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.
Hortensia Reyes-Morales, DrSc principal investigator
Instituto Nacional de Salud Publica, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing primary obesity prevention in people with Obesity, run by Instituto Nacional de Salud Publica, 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 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 21 Aug 2018. 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?
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?
Child's age-associated Body Mass Index (time frame: Change from baseline (May 2011) at one year follow-up (November 2012)). 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 NCT01679938, 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 21 Aug 2018.