Latino Mothers as Primary Agents of Change

NCT02441049 | Unknown DMC

• 1 other identifier: G00007105
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Behavior

Keywords

Latino; Hispanic; Diet; Family health; Promotora; Intervention

Outcome Measures

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

  Baseline, 4 months, 10 months

Secondary Outcomes (8)

• 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

  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

  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)

  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

  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

  Baseline, 4 months, 10 months

Study Arms (2)

Home-based promotora intervention

EXPERIMENTAL

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

Behavioral: Home-based promotora family intervention

Delayed treatment control

NO INTERVENTION

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

Interventions

Home-based promotora family intervention BEHAVIORAL

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

Home-based promotora intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

San Diego State University Research Foundation

San Diego, California, 92123, United States

Location

Related Publications (9)

• 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.

  PMID: 24643488 RESULT

• 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.

  PMID: 25375276 RESULT

• 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.

  PMID: 25810469 RESULT

• 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.

  RESULT

• 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.

  PMID: 23711676 RESULT

• 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.

  PMID: 27065160 RESULT

• 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.

  PMID: 26699670 RESULT

• 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.

  PMID: 30285755 DERIVED

• 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.

  PMID: 29212358 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Guadalupe X Ayala, PhD, MPH

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 12, 2015
• Study Start: July 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: September 1, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

US (1)