NCT03781856

Brief Summary

Mariposa Community Health Center, a health center in Nogales, Arizona on the US-Mexico border, will provide a program to prevent obesity in children and create a community environment that supports a healthy lifestyle. Mariposa designed and implemented the La Vida Buena ("The Good Life") program and already know that helps families eat more healthily and exercise. Mariposa Community Health Center will test this program on younger children aged 5-8 years old. Providers will refer children who are overweight or obese to the La Vida Buena Program. In order to determine if the La Vida Buena program works, Mariposa Community Health center will implement the 8-week program with 100 overweight or obese children in their Nogales clinic. They will measure their weight (BMI), exercise levels and food habits at the beginning of the program and then 3- months and 6-months after the program ends. Mariposa will compare these results to children in the nearby Rio Rico clinic who do not receive the La Vida Buena program. These 100 overweight or obese children in Rio Rico will instead receive one educational session, and the same information will be collected regarding BMI, exercise level and food habits. After the 6-month period, the children from Rio Rico will be able to receive the full La Vida Buena program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

2.5 years

First QC Date

December 18, 2018

Last Update Submit

April 26, 2021

Conditions

Keywords

childhood obesityinterventioncommunity health workerscommunity-based

Outcome Measures

Primary Outcomes (1)

  • BMI

    Weight and height measured at baseline, post intervention and 6 months.

    baseline to 6 months follow up

Secondary Outcomes (4)

  • Physical activity

    baseline to 6 months follow up

  • Fruit and vegetable consumption

    baseline to 6 months follow up

  • Simple carbohydrate consumption

    baseline to 6 months follow up

  • Family healthy habits

    baseline to 6 months follow up

Study Arms (2)

La Vida Buena Program

EXPERIMENTAL

Administered in a group setting over the course of 8 weeks in a community setting.

Behavioral: La Vida Buena Program

Brief educational session

ACTIVE COMPARATOR

Administered one on one or in a group setting in a one-hour session at the clinic

Behavioral: Brief Educational Session

Interventions

The intervention is series of interactive one hour weekly classes over the course of 8 weeks related to child healthy weight, exercise and nutrition. Facilitated by community health workers, the classes are interactive and play-based and designed to engage both the child and accompanying parent or guardian in activities.

La Vida Buena Program

A one hour session about nutrition and physical activity to address obesity facilitated by a community health worker

Brief educational session

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 8 years of age
  • Above the 85th percentile for obesity
  • Accompanied by a parent or legal guardian.

You may not qualify if:

  • Not between the ages of 5 and 8
  • Not above the 85th percentile for obesity.
  • Not accompanied by a parent or legal guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mariposa Community Health Center

Nogales, Arizona, 85621, United States

Location

Related Publications (1)

  • Tucker KM, Ingram M, Doubleday K, Piper R, Carvajal SC. La Vida Buena (The Good Life) evaluation: a quasi experimental intervention of a community health worker-led family-based childhood obesity program for Latino children 5-8 years of age on the US-Mexico border. BMC Public Health. 2019 Jun 14;19(1):759. doi: 10.1186/s12889-019-7081-x.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maia Ingram

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2018

First Posted

December 20, 2018

Study Start

November 15, 2017

Primary Completion

June 1, 2020

Study Completion

September 1, 2020

Last Updated

April 27, 2021

Record last verified: 2021-04

Locations