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Family Wellness Education for Childhood Obesity
N/A
Recruiting
Led By Ana M Linares, DNS
Research Sponsored by Ana Maria Linares
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 1, 3, and 6 months.
Awards & highlights
Study Summary
This trial aims to reduce childhood obesity in Latinx families by using a family-oriented intervention to teach healthy feeding and lifestyle practices to kids 2-5 yrs old. They'll compare two approaches, and assess their short-term changes on diet and measurements.
Who is the study for?
This trial is for Latinx families of Mexican or Central American descent living in Central Kentucky, with at least one parent aged 18+ and a child between 2-5 years old who is overweight or obese. They must plan to stay in the area for at least a year and have internet access.Check my eligibility
What is being tested?
The 'AyUDA' program aims to engage parents in healthy lifestyle choices for their young children to reduce childhood obesity. It's a study comparing two methods: one using telehealth deep cultural level group sessions, and another with traditional educational materials.See study design
What are the potential side effects?
Since this intervention involves education and lifestyle changes rather than medication, there are no typical medical side effects. However, participants may experience changes in family dynamics as they adjust to new behaviors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at 1, 3, and 6 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 1, 3, and 6 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in scores of the Caregiver's Feeding Style Questionnaire
Change in scores of the Child Feeding Questionnaire
Intervention completion for AyUDA.
+2 moreSecondary outcome measures
Change in Body Mass Index (BMI)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: VirtualExperimental Treatment1 Intervention
This group will participate in weekly virtual group sessions facilitated by a culturally similar and trained health educator (Promotora). The virtual modules will be on a platform such as Zoom and will last approximately 90 minutes each. Each module will last 60 minutes with the following three components: 1) 15-minute video on behavior change-related module objective, 2) 15-minute vignette/story depicting a family implementing behavior change, and 3) 15-minute discussion on creating goals and overcoming barriers for behavior change pertaining to the module. The remaining 15-minutes will ask participants to share what worked well towards achieving goals set in the prior module
Group II: TraditionalActive Control1 Intervention
This group will get the same educational materials in writing (slides with information from video, written story, and instructions on goal setting and overcoming barriers) and receive a phone call from one of the researchers each week (5 weeks in a row) to provide an opportunity to respond questions, comments, and provide guidance about following the recommendations of the written material
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Who is running the clinical trial?
Ana Maria LinaresLead Sponsor
1 Previous Clinical Trials
39 Total Patients Enrolled
University of KentuckyOTHER
187 Previous Clinical Trials
226,914 Total Patients Enrolled
Ana M Linares, DNSPrincipal InvestigatorUniversity of Kentucky
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- N/AI am a parent over 18 with a child aged 2-5 who is overweight or obese.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual
- Group 2: Traditional
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limitation for this clinical trial above twenty years?
"This clinical investigation is seeking individuals between the ages of 2 and 60 years old to participate in its research."
Answered by AI
Are there still vacancies available to take part in this experiment?
"Per information hosted on clinicaltrials.gov, prospective patients are actively being recruited for this investigation which first appeared online on July 21st 2023 and was updated most recently in the last few days of that same month."
Answered by AI
Who meets the eligibility criteria for this research project?
"To meet the criteria for this trial, applicants should present with childhood obesity and be within the 2 - 60 age range. A total of 50 participants are needed to complete the research project."
Answered by AI
What is the target enrollment for this clinical trial?
"Affirmative. Information available on clinicaltrials.gov asserts that this research effort, which was first advertised on July 21st 2023, is actively recruiting participants across 2 different medical centers with an aim to enrol 50 patients in total."
Answered by AI
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