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La Vida Buena Childhood Obesity Program

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ClinicalTrials.gov Identifier: NCT03781856
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
Mariposa Community Health Center
Information provided by (Responsible Party):
University of Arizona

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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: La Vida Buena Program Behavioral: Brief Educational Session Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : September 1, 2020

Arm Intervention/treatment
Experimental: La Vida Buena Program
Administered in a group setting over the course of 8 weeks in a community setting.
Behavioral: La Vida Buena Program
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.

Active Comparator: Brief educational session
Administered one on one or in a group setting in a one-hour session at the clinic
Behavioral: Brief Educational Session
A one hour session about nutrition and physical activity to address obesity facilitated by a community health worker




Primary Outcome Measures :
  1. BMI [ Time Frame: baseline to 6 months follow up ]
    Weight and height measured at baseline, post intervention and 6 months.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781856


Contacts
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Contact: Maia Ingram, MPH 5202756369 maiai@email.arizona.edu
Contact: Katherin Tucker, MPH 520 6263877 ktucker@email.arizona.edu

Locations
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United States, Arizona
Mariposa Community Health Center Recruiting
Nogales, Arizona, United States, 85621
Contact: Rosie Piper    520-281-2860    rpiper@mariposachc.net   
Contact: Parry Molina, BA    5202812860    pmolina@mariposachc.net   
Sub-Investigator: Scott Carvajal, PhD         
Mariposa Community Health Center Recruiting
Nogales, Arizona, United States, 85621
Contact: Rosie Piper, BA    520-281-2860    rpiper@mariposa.net   
Contact: Patty Molina, BA    520 281 2860    pmolina@mariposa.net   
Sub-Investigator: Scott Carvajal, PhD         
Sponsors and Collaborators
University of Arizona
Mariposa Community Health Center
Investigators
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Principal Investigator: Maia Ingram University of Arizona

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03781856     History of Changes
Other Study ID Numbers: 1710977008
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Arizona:
childhood obesity
intervention
community health workers
community-based

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms