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Completed

NCT Number: NCT03781856

La Vida Buena Childhood Obesity Program

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.

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Key information

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mariposa Community Health Center

Nogales, Arizona, 85621, United States

About this study

La Vida Buena is a Mariposa project to educate children and families about healthy eating and exercise habits. The Health providers at Mariposa Nogales and Rio Rico clinics will refer children between 5-8 years old who are overweight or obese and their parents. Each child must participate with a parent or adult caregiver who is at least 18 years old. Before the program begins, the participant will attend an informational consent/registration session where they will be asked to sign a consent form for themselves and their child if they want to participate. The study will ask for certain information from each participant in order to determine if the program is working. Each family will respond to a questionnaire at three points: at the beginning of the program, three months after beginning the program, and six months after beginning the program, for a total of six months.

The questionnaire will include questions about fruit, vegetable and carbohydrate consumption, family behavior and habits regarding eating and exercise, moderate and vigorous physical activity, sedentary behavior, local foods and environment factors that impact the family. In addition, the child's weight will be measured at each time point.

Participation in La Vida Buena will take 6 months. At the Nogales site, participants will be invited to a series of weekly classes over the course of 8 weeks that are being offered by the Mariposa clinic related to child healthy weight, exercise and nutrition. At the Rio Rico site, participants will be offered one face to face educational session about child healthy weight with Mariposa staff. Participants will be scheduled for BMI measurements and questionnaires three months after initiating the program, as well as six months after initiating the La Vida Buena Program.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

La Vida Buena Program

Behavioral

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.

Brief Educational Session

Behavioral

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

Primary outcomes

  1. BMI

    Time frame: baseline to 6 months follow up

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

Secondary outcomes

  1. Physical activity

    Time frame: baseline to 6 months follow up

    Increased physical activity as measured by the International Physical Activity Questionnaire - Short Form

  2. Fruit and vegetable consumption

    Time frame: baseline to 6 months follow up

    As measured by self reported servings per day or week with higher values considered to be a better outcome

  3. Simple carbohydrate consumption

    Time frame: baseline to 6 months follow up

    As measured by self report servings per day or week with lower values considered to be a better outcome

  4. Family healthy habits

    Time frame: baseline to 6 months follow up

    As measured by the Family Nutrition and Physical Activity Tool designed to capture healthy family habits. The adapted scale includes 16 items that are score from 1 to 4 that measure physical activity, sport participation, television viewing and video games for their negative influence on child hood obesity. Total score ranges from 16 to 64 points, with an increased score being associated with positive outcomes. There is not threshold or cutoff for the scale.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • Mariposa Community Health Center

Registry information

Official study title

La Vida Buena (The Good Life) Evaluation: A Quasi Experimental Intervention of a Community Health Worker Led Family-based Childhood Obesity Program for Hispanic Children 5-8 Years of Age on the US-Mexico Border

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2018
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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