Clinical trial NCT03781856: La Vida Buena Childhood Obesity Program
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: childhood obesity
intervention
community health workers
community-based
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Mariposa Community Health Center
First posted: 2018-12-20
Enrollment: 160
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: BMI
timeFrame: baseline to 6 months follow up
Secondary outcomes:
measure: Physical activity
timeFrame: baseline to 6 months follow up
measure: Fruit and vegetable consumption
timeFrame: baseline to 6 months follow up
measure: Simple carbohydrate consumption
timeFrame: baseline to 6 months follow up
measure: Family healthy habits
timeFrame: baseline to 6 months follow up
Other outcomes:
Locations:
city: Nogales
country: United States
facility: Mariposa Community Health Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Maia Ingram
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.