ObesityGEMASNCT00797615
Project Diabetes: Weight Gain Prevention in Hispanic Girls (GEMAS Study)
A study testing Active intervention and Alternative Intervention in people with Obesity and Diet, run by Vanderbilt University at 2 sites in United States.
Trial summary
Over the past 30 years obesity has reached epidemic proportions in the United States (Ogden et al, 2006). While this epidemic affects all socioeconomic levels, certain racial/ethnic groups such as Hispanics, are disproportionately affected by obesity and diabetes. Read more about this study
- Who is it for?
- Ages 8 to 10 years, women onlyHealthy volunteers can take part
- What is being tested?
- Active intervention and Alternative Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Jan 2010
- 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 8 to 10 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 8-10 year old Hispanic girls in Nashville
- The parent or guardian must identify the girl as Hispanic
- The parent or guardian must identify that the girl be at or above the 25th percentile of age- and sex-specific BMI based on the 2000 CDC growth charts or one parent/caregiver must have BMI>25 kg/m2.
Who cannot join
- Baseline girls' BMI>35
- Medical conditions and medications affecting growth
- Conditions limiting participation in the interventions (e.g., unable to participate in routine physical education classes in school)
- Conditions limiting participation in the assessments (e.g., two or more grades behind in school for reading and writing)
- Other criteria (e.g., inability or failure to provide informed consent).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Progreso Community Center
Nashville, Tennessee, 37211
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Over the past 30 years obesity has reached epidemic proportions in the United States (Ogden et al, 2006). While this epidemic affects all socioeconomic levels, certain racial/ethnic groups such as Hispanics, are disproportionately affected by obesity and diabetes. The age of onset of excess obesity in Hispanic females, formerly young adulthood, is now younger. Childhood obesity poses intermediate and long-term health risks, including: type 2 diabetes, hyperlipidemia, elevated blood pressure, and metabolic syndrome. Although biological factors may influence a child's risk for becoming overweight, the home environment has been shown to be a predisposing and reinforcing contextual factor for unhealthy eating and exercise behaviors. Since parents are the primary transmitters of Hispanic cultural practices and significantly influence their children's diet and physical activity behaviors from preschool through high school, family-based weight-gain prevention interventions are likely to be effective.
The goal of this implementation study is to contribute to the reduction of racial/ethnic disparities in obesity and risk of type 2 diabetes by tailoring a recently successful childhood obesity prevention program originally developed for African American girls to implement and evaluate with preadolescent Hispanic girls.
Read the detailed description
Over the past 30 years obesity has reached epidemic proportions in the United States (Ogden et al, 2006). While this epidemic affects all socioeconomic levels, certain racial/ethnic groups such as Hispanics, are disproportionately affected by obesity and diabetes. The age of onset of excess obesity in Hispanic females, formerly young adulthood, is now younger. Childhood obesity poses intermediate and long-term health risks, including: type 2 diabetes, hyperlipidemia, elevated blood pressure, and metabolic syndrome (Goran et al 2003; Hale and Rupert, 2006). Although biological factors may influence a child's risk for becoming overweight, the home environment has been shown to be a predisposing and reinforcing contextual factor for unhealthy eating and exercise behaviors (Arredondo et al, 2006).
Two recent empirical reviews of childhood obesity interventions demonstrated the increased effectiveness of family-based approaches (Kitzmann and Beech, 2006; Summerbell et al, 2007). Since parents are the primary transmitters of Hispanic cultural practices and significantly influence their children's diet and physical activity behaviors from preschool through high school (Snethen et al, 2007), family-based weight-gain prevention interventions are likely to be effective. The sociocultural context of Hispanic girls involves a much higher degree of interdependence among family members in Hispanic compared to White families (Schwartz, 2007). In addition to family-based approaches to pediatric obesity prevention, culturally-relevant and community-based participatory approaches have been strongly recommended by the Institute of Medicine (IOM) and the Strategic Plan for NIH Obesity Research (NIH, 2004:25).
The goal of this implementation study is to contribute to the reduction of racial/ethnic disparities in obesity and risk of type 2 diabetes by tailoring a recently successful childhood obesity prevention program originally developed for African American girls to implement and evaluate with preadolescence Hispanic girls. This project will be a collaborative, participatory community-academic partnership between Vanderbilt University Medical Center (VUMC), Tennessee State University (TSU) Center for Health Research, Meharry Medical College, Progreso Community Center (PCC) and the Nashville Latino Health Coalition (NLHC). Specifically, the childhood obesity prevention program called Girl's health Enrichment Multi-site Studies (GEMS) will be tailored to be culturally-appropriate and piloted in the Hispanic/Latino community in Nashville/Davidson County, Tennessee. Dr. Bettina Beech led the development of the original GEMS intervention, which was developed and pilot-tested in Memphis, Tennessee (Beech et al, 2003). We have assembled a multi-disciplinary team with expertise in pediatric obesity (Drs. Beech, Barkin, and Cook), type 2 diabetes (Dr. Tom Elasy), community-based participatory research (Drs. Beech, Barkin, Hull), Hispanic culture (Drs. Hull and Zoorob, PCC), and community engagement (NLHC, PCC, and Drs. Beech and Hull).
- Conditions
- Obesity, Diet, Exercise, Behavioral Research
- Being tested
- Active intervention, Alternative Intervention
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active interventionBehavioural
12-week family-based weight gain intervention program focused on dietary intake and physical activity for 8-10 year old Hispanic girls and their parents (N=30 girl-parent dyads).
Alternative InterventionBehavioural
12-week alternative intervention addressing self-esteem, for 8-10 year old Hispanic girls and their parents (N=30 girl-parent dyads).
| Study group | Role | What they receive |
|---|---|---|
| Alternative Intervention | Placebo comparator | 12-week alternate intervention program focused on building self-esteem and social self-efficacy Receives: Behavioral: Alternative Intervention |
| Active Intervention | Active comparator | 12-week intervention program focused on dietary intake and physical activity Receives: Behavioral: Active intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the between-group differences in BMI and body fat.
Measured: After 12 weeks of intervention
Secondary outcomes (1)
Secondary outcomes will include dietary intake and physical activity.
Measured: After 12 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2010
- Study completionJan 2010
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Bettina M. Beech, DrPH, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797615
- Sponsor's protocol ID
- 081057
- Acronym
- GEMAS
- Status last verified
- Oct 2010
- First submitted
- 21 Nov 2008
- Last updated
- 7 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Diabetes: Weight Gain Prevention in Hispanic Girls (GEMAS Study)
- ClinicalTrials.gov ID
- NCT00797615
- Acronym / sponsor ID
- GEMAS / 081057
- Conditions
- Obesity, Diet, Exercise, Behavioral Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Nov 2008 (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.
Over the past 30 years obesity has reached epidemic proportions in the United States (Ogden et al, 2006). While this epidemic affects all socioeconomic levels, certain racial/ethnic groups such as Hispanics, are disproportionately affected by obesity and diabetes. The age of onset of excess obesity in Hispanic females, formerly young adulthood, is now younger. Childhood obesity poses intermediate and long-term health risks, including: type 2 diabetes, hyperlipidemia, elevated blood pressure, and metabolic syndrome. Although biological factors may influence a child's risk for becoming overweight, the home environment has been shown to be a predisposing and reinforcing contextual factor for unhealthy eating and exercise behaviors. Since parents are the primary transmitters of Hispanic cultural practices and significantly influence their children's diet and physical activity behaviors from preschool through high school, family-based weight-gain prevention interventions are likely to be effective.
The goal of this implementation study is to contribute to the reduction of racial/ethnic disparities in obesity and risk of type 2 diabetes by tailoring a recently successful childhood obesity prevention program originally developed for African American girls to implement and evaluate with preadolescent Hispanic girls.
Detailed description
Over the past 30 years obesity has reached epidemic proportions in the United States (Ogden et al, 2006). While this epidemic affects all socioeconomic levels, certain racial/ethnic groups such as Hispanics, are disproportionately affected by obesity and diabetes. The age of onset of excess obesity in Hispanic females, formerly young adulthood, is now younger. Childhood obesity poses intermediate and long-term health risks, including: type 2 diabetes, hyperlipidemia, elevated blood pressure, and metabolic syndrome (Goran et al 2003; Hale and Rupert, 2006). Although biological factors may influence a child's risk for becoming overweight, the home environment has been shown to be a predisposing and reinforcing contextual factor for unhealthy eating and exercise behaviors (Arredondo et al, 2006).
Two recent empirical reviews of childhood obesity interventions demonstrated the increased effectiveness of family-based approaches (Kitzmann and Beech, 2006; Summerbell et al, 2007). Since parents are the primary transmitters of Hispanic cultural practices and significantly influence their children's diet and physical activity behaviors from preschool through high school (Snethen et al, 2007), family-based weight-gain prevention interventions are likely to be effective. The sociocultural context of Hispanic girls involves a much higher degree of interdependence among family members in Hispanic compared to White families (Schwartz, 2007). In addition to family-based approaches to pediatric obesity prevention, culturally-relevant and community-based participatory approaches have been strongly recommended by the Institute of Medicine (IOM) and the Strategic Plan for NIH Obesity Research (NIH, 2004:25).
The goal of this implementation study is to contribute to the reduction of racial/ethnic disparities in obesity and risk of type 2 diabetes by tailoring a recently successful childhood obesity prevention program originally developed for African American girls to implement and evaluate with preadolescence Hispanic girls. This project will be a collaborative, participatory community-academic partnership between Vanderbilt University Medical Center (VUMC), Tennessee State University (TSU) Center for Health Research, Meharry Medical College, Progreso Community Center (PCC) and the Nashville Latino Health Coalition (NLHC). Specifically, the childhood obesity prevention program called Girl's health Enrichment Multi-site Studies (GEMS) will be tailored to be culturally-appropriate and piloted in the Hispanic/Latino community in Nashville/Davidson County, Tennessee. Dr. Bettina Beech led the development of the original GEMS intervention, which was developed and pilot-tested in Memphis, Tennessee (Beech et al, 2003). We have assembled a multi-disciplinary team with expertise in pediatric obesity (Drs. Beech, Barkin, and Cook), type 2 diabetes (Dr. Tom Elasy), community-based participatory research (Drs. Beech, Barkin, Hull), Hispanic culture (Drs. Hull and Zoorob, PCC), and community engagement (NLHC, PCC, and Drs. Beech and Hull).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative Intervention | Placebo comparator | Behavioral: Alternative Intervention12-week alternate intervention program focused on building self-esteem and social self-efficacy |
| Active Intervention | Active comparator | Behavioral: Active intervention12-week intervention program focused on dietary intake and physical activity |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 8-10 year old Hispanic girls in Nashville
- The parent or guardian must identify the girl as Hispanic
- The parent or guardian must identify that the girl be at or above the 25th percentile of age- and sex-specific BMI based on the 2000 CDC growth charts or one parent/caregiver must have BMI>25 kg/m2.
Key exclusion criteria (5 listed)
- Baseline girls' BMI>35
- Medical conditions and medications affecting growth
- Conditions limiting participation in the interventions (e.g., unable to participate in routine physical education classes in school)
- Conditions limiting participation in the assessments (e.g., two or more grades behind in school for reading and writing)
- Other criteria (e.g., inability or failure to provide informed consent).
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 |
|---|---|---|
| Active intervention12-week family-based weight gain intervention program focused on dietary intake and physical activity for 8-10 year old Hispanic girls and their parents (N=30 girl-parent dyads). | Behavioural | Active Intervention |
| Alternative Intervention12-week alternative intervention addressing self-esteem, for 8-10 year old Hispanic girls and their parents (N=30 girl-parent dyads). | Behavioural | Alternative Intervention |
Primary outcome
The primary outcome measure will be the between-group differences in BMI and body fat.
Time frame: After 12 weeks of intervention
1 secondary outcome
Secondary outcomes will include dietary intake and physical activity.
Time frame: After 12 weeks of intervention.
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 7 Oct 2010.
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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.
Bettina M. Beech, DrPH, MPH principal investigator
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active intervention and Alternative Intervention in people with Obesity and Diet, run by Vanderbilt University at 2 sites in United States.
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 5 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 7 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
The primary outcome measure will be the between-group differences in BMI and body fat. (time frame: After 12 weeks of intervention). 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 7 Oct 2010.