Overview

This trial is active, not recruiting.

Condition eating behavior
Treatment home-based promotora family intervention
Sponsor San Diego State University
Collaborator American Cancer Society, Inc.
Start date July 2007
End date February 2011
Trial size 361 participants
Trial identifier NCT02441049, G00007105

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Study participants and their families received the home-based promotora family intervention
home-based promotora family intervention Entre Familia: Reflejos de Salud
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.
(No Intervention)
Study participants received intervention materials after the final study evaluation measures were taken, 10 months post-baseline.

Primary Outcomes

Measure
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

Measure
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
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
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
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
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
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
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
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Latino Mothers as Primary Agents of Change
Principal investigator Guadalupe X Ayala, PhD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by San Diego State University.