Latino Mothers as Primary Agents of Change

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

361 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2020-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Eating Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Home-based promotora intervention

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

Group Type EXPERIMENTAL

Home-based promotora family intervention

Intervention Type 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.

Delayed treatment control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Entre Familia: Reflejos de Salud

Eligibility Criteria

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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.