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Latino Mothers as Primary Agents of Change

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ClinicalTrials.gov Identifier: NCT02441049
Recruitment Status : Unknown
Verified April 2020 by Guadalupe X. Ayala, San Diego State University.
Recruitment status was:  Active, not recruiting
First Posted : May 12, 2015
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Guadalupe X. Ayala, San Diego State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Eating Behavior Behavioral: Home-based promotora family intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Latino Mothers as Primary Agents of Change
Study Start Date : July 2007
Actual Primary Completion Date : February 2011
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

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 Name: 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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441049


Locations
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United States, California
San Diego State University Research Foundation
San Diego, California, United States, 92123
Sponsors and Collaborators
San Diego State University
American Cancer Society, Inc.
Investigators
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Principal Investigator: Guadalupe X Ayala, PhD, MPH San Diego State University
Publications of Results:
Ayala, G.X., Ibarra, L., Arredondo, E., Horton, L., Hernandez, E., Parada, H., Slymen, D., Rock, C., Engelberg, M., Elder, J.P. (2011). Promoting healthy eating by strengthening family relations: Design and implementation of the Entre Familia: Reflejos de Salud intervention. In R. Elk & H. Landrine (Eds.), Cancer Disparities: Causes and Evidence-Based Solutions. Springer.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guadalupe X. Ayala, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT02441049    
Other Study ID Numbers: G00007105
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Keywords provided by Guadalupe X. Ayala, San Diego State University:
Latino
Hispanic
Diet
Family health
Promotora
Intervention