Latino Mothers as Primary Agents of Change

April 18, 2020 updated by: Guadalupe X. Ayala, San Diego State University
Entre Familia was a 4-year randomized controlled trial funded by the American Cancer Society. The study was conducted in Imperial County, California, and involved a partnership between the Institute for Behavioral and Community Health at San Diego State University and Clínicas de Salud del Pueblo, Inc. a private, non-profit corporation providing comprehensive primary care services to residents throughout Imperial and Riverside Counties. The investigators enrolled 361 Latina mothers and one of their children aged between 7 and 13 years old; in 25% of families, the father was also enrolled. Participants were randomly assigned to either an intervention or delayed-treatment control condition. The intervention consisted of a community health worker (or promotora)-delivered home-based intervention to promote healthy eating. The promotoras used a telenovela DVD series and accompanying manual, both written and produced by study staff. The intervention was delivered through 11 home visits and 4 support telephone calls over a 4 month period. Participants in the delayed-treatment condition received intervention materials when evaluation assessments had been completed. Evaluation measures were taken at baseline, 4 months (immediate post-intervention) and 10 months (6-months post intervention). Participants completed a self-report interview with study staff at each time point. Height and weight measurements were also collected for the mothers and children. The primary outcomes were changes in mothers' daily fruit and vegetable intake. Secondary outcomes for mothers, children and fathers included changes in fat intake, sugary beverage intake, parenting strategies, and perceived barriers to healthy eating.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

361

Phase

  • 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

  • United States
    • California
      • San Diego, California, United States, 92123
        • San Diego State University Research Foundation

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Mothers:

  • must self-identify as Latina,
  • must be able to read and speak Spanish,
  • must be at least 18 years old,
  • must be a resident of Imperial County,
  • and must plan to reside in the county for the 10 month study duration.

Children (both genders):

  • must be between the ages of 7-13 years,
  • must reside with his/her mother and her spouse/partner for at least 4 days of the week.

Exclusion Criteria:

  • Families who intend to move away from Imperial County before the end of the study, and families with a family member on a medically-prescribed diet

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-based promotora intervention
Study participants and their families received the home-based promotora family intervention
Behavioral: Home-based promotora family intervention
A promotora-delivered family intervention in the participant's home. Promotoras used a telenovela-style DVD and accompanying manual to deliver 11 home sessions to the family, and 4 support telephone calls, over a 4 month period.
Other Names:
  • Entre Familia: Reflejos de Salud
No Intervention: Delayed treatment control
Study participants received intervention materials after the final study evaluation measures were taken, 10 months post-baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in mother daily fruit and vegetable intake in the past month between baseline, immediate-post intervention and 6-months post-intervention, assessed using the NCI Fruit and Vegetable All-Day Screener
Time Frame: Baseline, 4 months, 10 months
Baseline, 4 months, 10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Child, father: change in daily fruit and vegetable intake in the past month between baseline, immediate-post intervention and 6-months post-intervention, assessed using the NCI Fruit and Vegetable All-Day Screener
Time Frame: Baseline, 4 months, 10 months
Baseline, 4 months, 10 months
Mother, child, father: change in monthly fruit and vegetable variety between baseline, immediate-post intervention and 6-months post-intervention, assessed using self-reported intake of 32 fruits and 43 vegetables
Time Frame: Baseline, 4 months, 10 months
Baseline, 4 months, 10 months
Mother, father: change in perceived quality of diet between baseline, immediate-post intervention and 6-months post-intervention, assessed using one item from the 2005-06 NHANES (Diet Behavior and Nutrition module)
Time Frame: Baseline, 4 months, 10 months
Baseline, 4 months, 10 months
Mother, father: change in parenting strategies between baseline, immediate-post intervention and 6-months post-intervention, assessed using a modified version of the PEAS scale
Time Frame: Baseline, 4 months, 10 months
Baseline, 4 months, 10 months
Mother: change in social support for fruit and vegetable intake between baseline, immediate-post intervention and 6-months post-intervention, assessed using a modified version of preexisting F&V shopping practices and social support scales
Time Frame: Baseline, 4 months, 10 months
Baseline, 4 months, 10 months
Mother, child, father: change in weekly fast food intake between baseline, immediate-post intervention and 6-months post-intervention, assessed by asking for self-reported number of days in a typical week the respondent ate at fast food restaurants
Time Frame: Baseline, 4 months, 10 months
Baseline, 4 months, 10 months
Mother, father: change in perceived barriers to obtaining and consuming fruits and vegetables between baseline, immediate-post intervention and 6-months post-intervention, assessed using 11-items including ease of purchasing F&V in the neighborhood
Time Frame: Baseline, 4 months, 10 months
Baseline, 4 months, 10 months
Mother, father: change in fat intake between baseline, immediate-post intervention and 6-months post-intervention, assessed using the NCI Multifactor Fat Screener
Time Frame: Baseline, 4 months, 10 months
Baseline, 4 months, 10 months

Collaborators and Investigators

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

Sponsor

San Diego State University

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Guadalupe X Ayala, PhD, MPH, San Diego State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 18, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • G00007105

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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