ObesityCHICOSNCT00454948
Nutrition Intervention and Play Group Exercise for Low-income Latinas
A study testing Home-based nutrition sessions and play group exercise and Group-based nutrition sessions and mail-out activities in people with Obesity, run by Stanford University at 1 site in United States.
Trial summary
Obesity among Mexican-American women has the potential to become a public health crisis. Hispanics are one of the fastest growing minority populations in the United States and the prevalence of obesity in Mexican American woman is increasing at an alarming rate. 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?
- Home-based nutrition sessions and play group exercise and Group-based nutrition sessions and mail-out activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Aug 2009
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother is of Mexican descent
- Mother has a child between the ages of 3 and 4.9 years
Who cannot join
- Child is eligible for kindergarten in the upcoming 6 months
- Mother is pregnant
- Mother is less then 4 months post partum
- Family plans on moving outside of San Jose in the upcoming 6 months
- Family shares food supplies with more than one other household
- Mother has medical condition or takes medication that affects weight
- Child has medical condition or takes medication that affects weight or growth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home Based Nutrition Intervention Nad Play Group Exercise for Low-income Latinas
Obesity among Mexican-American women has the potential to become a public health crisis. Hispanics are one of the fastest growing minority populations in the United States and the prevalence of obesity in Mexican American woman is increasing at an alarming rate. Poor dietary practices, especially food habits that are acquired as families acculturate to the American food supply, and lack of exercise are thought to be associated with women's excess weight gain. Accordingly, interventions are needed to improve the dietary intake and physical activity levels of Mexican-American families.
We propose to conduct a randomized clinical trial in which women are randomly assigned to receive either family-based behavioral counseling (FBC) sessions and play group physical activity sessions or group based nutrition and exercise classes and health related activity worksheets to complete with their child. The FBC sessions, conducted by community health advisors, will use photographs of the family's food practices, taken by mothers, as visual aids in the counseling sessions. The control intervention will consist of group sessions using curricula designed to motivate women to exercise and to promote the Food Guide Pyramid recommendations using traditional Mexican-American foods. The primary outcome of the trial is mother's BMI. The secondary outcomes are dietary intake, moderate to vigorous physical activity and household food supplies. We hypothesize that within a one year time frame, women who are exposed to the FBC will have lower BMI's compared to women who receive the active placebo control intervention. The mechanisms through which we intend to change weight status are altering the type of foods purchased and cooking practices and promoting mothers to engage in physical activities with their children during their play. Measurements of secondary outcomes include three 24 hour dietary recalls, a household food inventory and activity monitoring using MTI actigraph monitors. In addition, mothers' reports of household food security level, and food purchase motives, will be collected as covariates. Measurements will be collected within one month of completing the interventions and at six months and one year follow-up.
Read the detailed description
We propose to evaluate a family-based intervention designed to prevent obesity by increasing fruit and vegetable (F\&V) intake, decreasing fat intake and increasing physical activity. The target group for the intervention is low-income Mexican-American mothers of preschool aged children. The intervention uses family-based behavioral counseling (FBC) sessions with a community health advisor (CHA) to promote changing the types of foods that mothers prepare and consume, and increasing the time that mothers spend being active with their children. In previous research, we have used this approach to improve Mexican-American school aged children's nutritional status. The mothers of these children were extremely motivated to improve their children's diets, and in doing so, improved their own health behaviors and reduced their BMI's. Accordingly, in the proposed research, we will conduct a randomized controlled trial with a sample of 250 Mexican-American mothers-child dyads to evaluate a family based intervention designed to prevent obesity in low income Mexican-American women. As families enroll in the study, they will be randomly assigned to either the FBC sessions or an active placebo control condition. Data will be collected immediately prior to participation in the intervention, within one-month of completing the intervention and at six months and one year follow-up. Mother's body mass index (BMI) will serve as the primary outcome variable. Multiple 24-hour dietary recalls, a modified household food inventory and physical activity monitoring will be used as secondary indices of program efficacy. The following hypotheses will be examined in this experiment.
Primary Hypothesis Women who receive the FBC sessions will have significantly lower BMI one year after randomization into the intervention compared to women whose families receive an active placebo control.
Secondary Hypotheses
Women who receive the FBC sessions will have significantly lower fat intakes and higher fruit and vegetable intakes, as measured by 24 hour recalls, one year after randomization into the intervention compared to women whose families receive an active placebo control.
Women who receive the FBC sessions will have significantly fewer high fat foods and significantly more fruits and vegetables in their homes, as measured by targeted household food inventories, one year after randomization into the intervention compared to women whose families receive an active placebo control.
Women who receive the FBC sessions will be significantly more active one year after randomization into the intervention, as measured by activity monitoring, compared to women whose families receive an active placebo control.
- Conditions
- Obesity
- Being tested
- Home-based nutrition sessions and play group exercise, Group-based nutrition sessions and mail-out activities
- Keywords
- Obesity prevention, Dietary intake, Physical activity, Mexican American, Family Characteristics
- 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.
Home-based nutrition sessions and play group exerciseBehavioural
Group-based nutrition sessions and mail-out activitiesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Home based Nutrition and Physical Activity | Experimental | Home-based nutrition sessions and park play activity sessions Receives: Behavioral: Home-based nutrition sessions and play group exercise |
| Group Nutrtion | Active comparator | Group based nutrition classes and activity booklets Receives: Behavioral: Group-based nutrition sessions and mail-out activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI at one year after randomization
Secondary outcomes (3)
BMI percentile score of children one year after intervention
Dietary intake of mothers and their child one year after intervention as measured by multiple 24 hour recalls
Physical activity of mother and their child as measured by actigraph monitoring.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2008
- Study completionAug 2009
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donna M Matheson, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454948
- Sponsor's protocol ID
- R01DK073377-01
- Acronym
- CHICOS
- Status last verified
- May 2022
- First submitted
- 29 Mar 2007
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Based Nutrition Intervention Nad Play Group Exercise for Low-income Latinas
- ClinicalTrials.gov ID
- NCT00454948
- Acronym / sponsor ID
- CHICOS / R01DK073377-01
- Conditions
- Obesity
- Keywords
- Obesity prevention, Dietary intake, Physical activity, Mexican American, Family Characteristics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Apr 2007 (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.
Obesity among Mexican-American women has the potential to become a public health crisis. Hispanics are one of the fastest growing minority populations in the United States and the prevalence of obesity in Mexican American woman is increasing at an alarming rate. Poor dietary practices, especially food habits that are acquired as families acculturate to the American food supply, and lack of exercise are thought to be associated with women's excess weight gain. Accordingly, interventions are needed to improve the dietary intake and physical activity levels of Mexican-American families.
We propose to conduct a randomized clinical trial in which women are randomly assigned to receive either family-based behavioral counseling (FBC) sessions and play group physical activity sessions or group based nutrition and exercise classes and health related activity worksheets to complete with their child. The FBC sessions, conducted by community health advisors, will use photographs of the family's food practices, taken by mothers, as visual aids in the counseling sessions. The control intervention will consist of group sessions using curricula designed to motivate women to exercise and to promote the Food Guide Pyramid recommendations using traditional Mexican-American foods. The primary outcome of the trial is mother's BMI. The secondary outcomes are dietary intake, moderate to vigorous physical activity and household food supplies. We hypothesize that within a one year time frame, women who are exposed to the FBC will have lower BMI's compared to women who receive the active placebo control intervention. The mechanisms through which we intend to change weight status are altering the type of foods purchased and cooking practices and promoting mothers to engage in physical activities with their children during their play. Measurements of secondary outcomes include three 24 hour dietary recalls, a household food inventory and activity monitoring using MTI actigraph monitors. In addition, mothers' reports of household food security level, and food purchase motives, will be collected as covariates. Measurements will be collected within one month of completing the interventions and at six months and one year follow-up.
Detailed description
We propose to evaluate a family-based intervention designed to prevent obesity by increasing fruit and vegetable (F\&V) intake, decreasing fat intake and increasing physical activity. The target group for the intervention is low-income Mexican-American mothers of preschool aged children. The intervention uses family-based behavioral counseling (FBC) sessions with a community health advisor (CHA) to promote changing the types of foods that mothers prepare and consume, and increasing the time that mothers spend being active with their children. In previous research, we have used this approach to improve Mexican-American school aged children's nutritional status. The mothers of these children were extremely motivated to improve their children's diets, and in doing so, improved their own health behaviors and reduced their BMI's. Accordingly, in the proposed research, we will conduct a randomized controlled trial with a sample of 250 Mexican-American mothers-child dyads to evaluate a family based intervention designed to prevent obesity in low income Mexican-American women. As families enroll in the study, they will be randomly assigned to either the FBC sessions or an active placebo control condition. Data will be collected immediately prior to participation in the intervention, within one-month of completing the intervention and at six months and one year follow-up. Mother's body mass index (BMI) will serve as the primary outcome variable. Multiple 24-hour dietary recalls, a modified household food inventory and physical activity monitoring will be used as secondary indices of program efficacy. The following hypotheses will be examined in this experiment.
Primary Hypothesis Women who receive the FBC sessions will have significantly lower BMI one year after randomization into the intervention compared to women whose families receive an active placebo control.
Secondary Hypotheses
Women who receive the FBC sessions will have significantly lower fat intakes and higher fruit and vegetable intakes, as measured by 24 hour recalls, one year after randomization into the intervention compared to women whose families receive an active placebo control.
Women who receive the FBC sessions will have significantly fewer high fat foods and significantly more fruits and vegetables in their homes, as measured by targeted household food inventories, one year after randomization into the intervention compared to women whose families receive an active placebo control.
Women who receive the FBC sessions will be significantly more active one year after randomization into the intervention, as measured by activity monitoring, compared to women whose families receive an active placebo control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home based Nutrition and Physical Activity | Experimental | Behavioral: Home-based nutrition sessions and play group exerciseHome-based nutrition sessions and park play activity sessions |
| Group Nutrtion | Active comparator | Behavioral: Group-based nutrition sessions and mail-out activitiesGroup based nutrition classes and activity booklets |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Mother is of Mexican descent
- Mother has a child between the ages of 3 and 4.9 years
Key exclusion criteria (7 listed)
- Child is eligible for kindergarten in the upcoming 6 months
- Mother is pregnant
- Mother is less then 4 months post partum
- Family plans on moving outside of San Jose in the upcoming 6 months
- Family shares food supplies with more than one other household
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 |
|---|---|---|
| Home-based nutrition sessions and play group exercise | Behavioural | Home based Nutrition and Physical Activity |
| Group-based nutrition sessions and mail-out activities | Behavioural | Group Nutrtion |
Primary outcome
BMI at one year after randomization
3 secondary outcomes
BMI percentile score of children one year after intervention
Dietary intake of mothers and their child one year after intervention as measured by multiple 24 hour recalls
Physical activity of mother and their child as measured by actigraph monitoring.
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 31 May 2022.
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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.
Donna M Matheson, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based nutrition sessions and play group exercise and Group-based nutrition sessions and mail-out activities in people with Obesity, run by Stanford University at 1 site 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 2 inclusion and 7 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 31 May 2022. 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 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. 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?
BMI at one year after randomization. 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 31 May 2022.