Nutrition Intervention and Play Group Exercise for Low-income Latinas (CHICOS)

May 25, 2022 updated by: Stanford University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Mother is of Mexican descent
  • Mother has a child between the ages of 3 and 4.9 years

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Home based Nutrition and Physical Activity
Home-based nutrition sessions and park play activity sessions
Behavioral: Home-based nutrition sessions and play group exercise
Active Comparator: Group Nutrtion
Group based nutrition classes and activity booklets
Behavioral: Group-based nutrition sessions and mail-out activities

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
BMI at one year after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Donna M Matheson, PhD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01DK073377-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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