La Vida Buena Childhood Obesity Program
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
La Vida Buena Program
Brief Educational Session
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring childhood obesity, intervention, community health workers, community-based
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.
Sites / Locations
- Mariposa Community Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
La Vida Buena Program
Brief educational session
Arm Description
Administered in a group setting over the course of 8 weeks in a community setting.
Administered one on one or in a group setting in a one-hour session at the clinic
Outcomes
Primary Outcome Measures
BMI
Weight and height measured at baseline, post intervention and 6 months.
Secondary Outcome Measures
Physical activity
Increased physical activity as measured by the International Physical Activity Questionnaire - Short Form
Fruit and vegetable consumption
As measured by self reported servings per day or week with higher values considered to be a better outcome
Simple carbohydrate consumption
As measured by self report servings per day or week with lower values considered to be a better outcome
Family healthy habits
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.
Full Information
NCT ID
NCT03781856
First Posted
December 18, 2018
Last Updated
April 26, 2021
Sponsor
University of Arizona
Collaborators
Mariposa Community Health Center
1. Study Identification
Unique Protocol Identification Number
NCT03781856
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
Mariposa Community Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
childhood obesity, intervention, community health workers, community-based
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
La Vida Buena Program
Arm Type
Experimental
Arm Description
Administered in a group setting over the course of 8 weeks in a community setting.
Arm Title
Brief educational session
Arm Type
Active Comparator
Arm Description
Administered one on one or in a group setting in a one-hour session at the clinic
Intervention Type
Behavioral
Intervention Name(s)
La Vida Buena Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Educational Session
Intervention Description
A one hour session about nutrition and physical activity to address obesity facilitated by a community health worker
Primary Outcome Measure Information:
Title
BMI
Description
Weight and height measured at baseline, post intervention and 6 months.
Time Frame
baseline to 6 months follow up
Secondary Outcome Measure Information:
Title
Physical activity
Description
Increased physical activity as measured by the International Physical Activity Questionnaire - Short Form
Time Frame
baseline to 6 months follow up
Title
Fruit and vegetable consumption
Description
As measured by self reported servings per day or week with higher values considered to be a better outcome
Time Frame
baseline to 6 months follow up
Title
Simple carbohydrate consumption
Description
As measured by self report servings per day or week with lower values considered to be a better outcome
Time Frame
baseline to 6 months follow up
Title
Family healthy habits
Description
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.
Time Frame
baseline to 6 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maia Ingram
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mariposa Community Health Center
City
Nogales
State/Province
Arizona
ZIP/Postal Code
85621
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is currently no plan in place, however in the future the data dictionaries and individual participant data will be available upon request
Citations:
PubMed Identifier
31200685
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.
Results Reference
derived
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La Vida Buena Childhood Obesity Program
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