CClinicalTrials.gg
Status unknownNCT02441049Updated Apr 21, 2020

Latino Mothers as Primary Agents of Change

An interventional study of Home-based promotora family intervention in Eating Behavior, sponsored by San Diego State University. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-21.

Sponsored by San Diego State University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
361
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Eating Behavior

Keywords

  • Latino
  • Hispanic
  • Diet
  • Family health
  • Promotora
  • Intervention
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In context

Lead sponsor

San Diego State University is the lead sponsor of 145 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
361 participants (actual)

Study arms

  • Experimental
    Home-based promotora intervention

    Study participants and their families received the home-based promotora family intervention

    Behavioral: Home-based promotora family intervention

  • No intervention
    Delayed treatment control

    Study participants received intervention materials after the final study evaluation measures were taken, 10 months post-baseline.

Interventions

  • BehavioralHome-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.

    Also known as: Entre Familia: Reflejos de Salud

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What researchers measure

Primary outcomes

  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 outcomes

  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

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Study locations

1 site
  • San Diego State University Research Foundation
    San Diego, California 92123, United States
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References and documents

Publications

  • Horton LA, Parada H, Slymen DJ, Arredondo E, Ibarra L, Ayala GX. Targeting children's dietary behaviors in a family intervention: 'Entre familia: reflejos de salud'. Salud Publica Mex. 2013;55 Suppl 3:397-405. PubMed 24643488 ↗
  • Ayala GX, Ibarra L, Horton L, Arredondo EM, Slymen DJ, Engelberg M, Rock CL, Hernandez E, Parada H, Elder JP. Evidence supporting a promotora-delivered entertainment education intervention for improving mothers' dietary intake: the Entre Familia: Reflejos de Salud Study. J Health Commun. 2015;20(2):165-76. doi: 10.1080/10810730.2014.917747. Epub 2014 Nov 6. PubMed 25375276 ↗
  • Schmied E, Parada H, Horton L, Ibarra L, Ayala G. A Process Evaluation of an Efficacious Family-Based Intervention to Promote Healthy Eating: The Entre Familia: Reflejos de Salud Study. Health Educ Behav. 2015 Oct;42(5):583-92. doi: 10.1177/1090198115577375. Epub 2015 Mar 25. PubMed 25810469 ↗
  • 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.
  • Schmied EA, Parada H, Horton LA, Madanat H, Ayala GX. Family support is associated with behavioral strategies for healthy eating among Latinas. Health Educ Behav. 2014 Feb;41(1):34-41. doi: 10.1177/1090198113485754. Epub 2013 May 27. PubMed 23711676 ↗
  • Parada H, Ayala GX, Horton LA, Ibarra L, Arredondo EM. Latino fathers' feeding-related parenting strategies on children's eating. Ecol Food Nutr. 2016 May-Jun;55(3):292-307. doi: 10.1080/03670244.2016.1161616. Epub 2016 Apr 11. PubMed 27065160 ↗
  • Soto SC, Arredondo EM, Horton LA, Ayala GX. Validation of the modified Parenting Strategies for Eating and Physical Activity Scale-Diet (PEAS-Diet) in Latino children. Appetite. 2016 Mar 1;98:55-62. doi: 10.1016/j.appet.2015.12.003. Epub 2015 Dec 15. PubMed 26699670 ↗
  • Arredondo EM, Ayala GX, Soto S, Slymen DJ, Horton LA, Parada H, Campbell N, Ibarra L, Engelberg M, Elder JP. Latina mothers as agents of change in children's eating habits: findings from the randomized controlled trial Entre Familia: Reflejos de Salud. Int J Behav Nutr Phys Act. 2018 Oct 1;15(1):95. doi: 10.1186/s12966-018-0714-0. PubMed 30285755 ↗
  • Horton LA, Ayala GX, Slymen DJ, Ibarra L, Hernandez E, Parada H, Rock CL, Arredondo EM, Elder JP. A Mediation Analysis of Mothers' Dietary Intake: The Entre Familia: Reflejos de Salud Randomized Controlled Trial. Health Educ Behav. 2018 Aug;45(4):501-510. doi: 10.1177/1090198117742439. Epub 2017 Dec 6. PubMed 29212358 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02441049
Lead sponsor
San Diego State University
Collaborators
American Cancer Society, Inc.
Responsible party
Guadalupe X. Ayala (Professor, San Diego State University) — Principal investigator
First posted
May 12, 2015
Start date
Jul 2007
Primary completion
Feb 2011
Completion
Sep 2020 (estimated)
Last update
Apr 21, 2020

Study contacts

Guadalupe X Ayala, PhD, MPH
principal investigator · San Diego State University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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