ClinicalTrials.Veeva

Menu

Latino Mothers as Primary Agents of Change

San Diego State University logo

San Diego State University

Status

Unknown

Conditions

Eating Behavior

Treatments

Behavioral: Home-based promotora family intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02441049
G00007105

Details and patient eligibility

About

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.

Enrollment

361 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

361 participants in 2 patient groups

Home-based promotora intervention
Experimental group
Description:
Study participants and their families received the home-based promotora family intervention
Treatment:
Behavioral: Home-based promotora family intervention
Delayed treatment control
No Intervention group
Description:
Study participants received intervention materials after the final study evaluation measures were taken, 10 months post-baseline.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems