search
Back to results

Latinx Family Wellness

Primary Purpose

Childhood Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AyuDa Virtual: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)
AyuDa Written: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)
Sponsored by
Ana Maria Linares
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Childhood Obesity, Latinx, Intervention, Deep level education

Eligibility Criteria

2 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Latinx family of Mexican or Central American descent At least one parent 18 years or older; with a child between 2-5 years old and classified as overweight or obese Intention to remain in Central Kentucky for at least a year after recruitment Access to the internet. Exclusion Criteria: n/a

Sites / Locations

  • Clinica Amiga, UK Primary Care Pediatrics, Kentucky Clinic South
  • Polk Dalton ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual

Traditional

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in scores of the Child Feeding Questionnaire
Evaluate change in scores of the Child Feeding Questionnaire (CFQ). A 31-item self-report questionnaire measuring parental beliefs, attitudes, and practices in relation to child feeding. Each item is measured using a 5-point Likert-type scale, with responses across seven factor-based domains. Scores range from 1 to 5 with higher scores indicating higher levels of each domain.
Change in scores of the Caregiver's Feeding Style Questionnaire
Evaluate change in scores of the Caregiver's Feeding Style Questionnaire (CFSQ). The CFSQ is a 19-item measure which classifies caregivers into 1 of 4 feeding styles. Items are scored on a 5-point scale (1=never-5=always), with higher scores indicating higher frequency of engagement in a specific feeding style.
Recruitment for AyUDA
Percentage of eligible participants enrolled during the planned recruitment period.
Intervention completion for AyUDA.
Percentage of treatment group participants that complete all intervention sessions
Retention for AyUDA.
Percentage of participants retained in the study until the conclusion

Secondary Outcome Measures

Change in Body Mass Index (BMI)
Evaluation of weight (kilograms) and height (meters) to calculate BMI (kg/m^2) by age and sex following the World Health Organization (WHO) Body mass index percentile by age and sex 2-5 years.

Full Information

First Posted
January 10, 2023
Last Updated
July 30, 2023
Sponsor
Ana Maria Linares
Collaborators
University of Kentucky
search

1. Study Identification

Unique Protocol Identification Number
NCT05735600
Brief Title
Latinx Family Wellness
Official Title
Leveraging Cultural Health Beliefs and Actions to Improve Latinx Family Wellness
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ana Maria Linares
Collaborators
University of Kentucky

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
Childhood is an opportune time to intervene in obesity because behaviors that are developed during this time can have long-lasting effects and disrupt trajectories of obesity. This proposal aims to test the feasibility (i.e., participant acceptance, adherence, and retention) of a family-oriented intervention "AyUDA" (Aprender y Utilizar Decisiones Apreciables-Learning and Utilizing Significant Choices). The culturally tailored, two-arm adapted intervention to engage Latinx parents in healthy feeding and lifestyle practices for their children 2-5 years old, thereby reducing early childhood overweight and obesity. The investigators will use concepts of the Social-Ecological Framework for Obesity among Latinx, and the Social Learning Theory that emphasizes the importance of observing, modeling, and imitating behaviors. This approach includes a community engagement partnership with one clinic that serves a great number of Latinx families with 2-5 aged children in Central Kentucky (General Pediatric Clinic-Clinica Amiga). The investigators propose a two-arm randomized clinical trial (RCT) randomly assigning participants to either a telehealth deep cultural level group or a culturally traditional educational group in a sample of 40 Latinx families who will be followed for six months after the intervention. Moreover, investigators will explore short-term changes of the intervention on dietary behavior changes and anthropometric measurements among family members. The feasibility study will inform effect sizes that will be used to estimate statistical power for a future R01 on Community Level Interventions to Improve Minority Health and Reduce Health Disparities, National Institute of Health (NIH).
Detailed Description
The feasibility and effectiveness of a family-oriented intervention entitled "AyUDA" will be tested. The AyUDA intervention will provide Latinx families with culturally tailored modules to take control of modifiable behaviors and help them avoid obesogenic behaviors. This study has a longitudinal RCT study design. The study will be conducted in the University of Kentucky Friendly Clinic (Clinica Amiga). Participants will be followed for six months after the intervention. At least one adult who agrees to participate will sign the informed consent and HIPAA authorization, including the children's assent form. We anticipate that recruitment would include non-English speaking subjects due to Latinx self-identity, and for this reason, consent will be obtained in Spanish. The PIs, Co-I, and RP are fluent in English/Spanish and familiar with Latinx culture. Randomization: Randomization occurs after the baseline interview. Researchers will prepare ordered envelopes that contain the treatment assignments, one set for each stratum. Within each stratum, the treatment assignments will be placed in blocks of 10 (i.e., five assignments to each of the treatment conditions). To minimize attrition, complete contact information from participants will be collected and they will be asked to provide the phone number of two individuals who will know how to contact them in the future. Escalating incentives will be provided during data collection encounters to maximize retention. Reminders will be sent monthly for the duration of the study. Data Collection: Data will be collected by the trained RS who are blind to the study conditions at the following times: T1-baseline at recruitment-pre-intervention and randomization, T2-two weeks after the intervention, T3-Three months after the intervention, and T4-Six months after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood Obesity, Latinx, Intervention, Deep level education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two complementary theoretical frameworks inform the proposed study. Social-Ecological Framework suggests that families are nested within multiple social contexts that can influence children's weight. At the macro level, policies can shape child obesity by supplementing families' ability to afford food (e.g., food stamps, income supports), at the messo (community) level, the built and social environments influence child obesity by providing or inhibiting access to healthy food options and safe areas to engage in physical activity. Within the family domain, family attributes, behaviors, functioning, and parental factors, directly shape child obesity. AyUDA targets the family domain by centering obesogenic (obesity-promoting) aspects and mechanisms within families. In concert with this domain, investigators draw from Social Learning Theory to account for how to influence change within the family domain by targeting parenting attitudes and behaviors.
Masking
ParticipantOutcomes Assessor
Masking Description
Randomization occurs after the baseline interview. The investigators will prepare ordered envelopes that contain the treatment assignments, one set for each stratum. Within each stratum, the treatment assignments will be placed in blocks of 10 (i.e., five assignments for each of the treatment conditions). Participants will be informed in the assigned group without mentioning if it's the intervention or match control group. Data will be collected by the trained RS who are blind to the study conditions of the participants.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual
Arm Type
Experimental
Arm Description
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
Arm Title
Traditional
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
AyuDa Virtual: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)
Intervention Description
The intervention was developed based on the Social Learning Theory, considering both environmental and cognitive factors influencing parent behavior and modeling for children. Researchers have modified a five-module virtual intervention from the "Cooking Healthy and Delicious Manual (Cocinando Delicioso y Saludable Manual, Spanish version), which incorporates behavior change strategies for improving diet quality, screen time, physical activity/sedentary behavior, socioeconomic status/food security, and sleep duration.
Intervention Type
Behavioral
Intervention Name(s)
AyuDa Written: Aprender y Utilizar Decisiones Apreciables (Spanish) - Learning and Utilizing Significant Choices (English)
Intervention Description
The intervention was developed based on the Social Learning Theory, considering both environmental and cognitive factors influencing parent behavior and modeling for children. Researchers have modified a five-module virtual intervention from the "Cooking Healthy and Delicious Manual (Cocinando Delicioso y Saludable Manual, Spanish version), which incorporates behavior change strategies for improving diet quality, screen time, physical activity/sedentary behavior, socioeconomic status/food security, and sleep duration.
Primary Outcome Measure Information:
Title
Change in scores of the Child Feeding Questionnaire
Description
Evaluate change in scores of the Child Feeding Questionnaire (CFQ). A 31-item self-report questionnaire measuring parental beliefs, attitudes, and practices in relation to child feeding. Each item is measured using a 5-point Likert-type scale, with responses across seven factor-based domains. Scores range from 1 to 5 with higher scores indicating higher levels of each domain.
Time Frame
Baseline and at 1, 3, and 6 months.
Title
Change in scores of the Caregiver's Feeding Style Questionnaire
Description
Evaluate change in scores of the Caregiver's Feeding Style Questionnaire (CFSQ). The CFSQ is a 19-item measure which classifies caregivers into 1 of 4 feeding styles. Items are scored on a 5-point scale (1=never-5=always), with higher scores indicating higher frequency of engagement in a specific feeding style.
Time Frame
Baseline and at 1, 3, and 6 months.
Title
Recruitment for AyUDA
Description
Percentage of eligible participants enrolled during the planned recruitment period.
Time Frame
From study start until enrollment closes up to 9 months.
Title
Intervention completion for AyUDA.
Description
Percentage of treatment group participants that complete all intervention sessions
Time Frame
From enrollment to end of intervention at 6 weeks
Title
Retention for AyUDA.
Description
Percentage of participants retained in the study until the conclusion
Time Frame
From enrollment to end of study at 8 months
Secondary Outcome Measure Information:
Title
Change in Body Mass Index (BMI)
Description
Evaluation of weight (kilograms) and height (meters) to calculate BMI (kg/m^2) by age and sex following the World Health Organization (WHO) Body mass index percentile by age and sex 2-5 years.
Time Frame
Baseline and at 6 months after the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Latinx family of Mexican or Central American descent At least one parent 18 years or older; with a child between 2-5 years old and classified as overweight or obese Intention to remain in Central Kentucky for at least a year after recruitment Access to the internet. Exclusion Criteria: n/a
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila M Barnhart, PhD
Phone
8593237282
Email
Sheila.Barnhart@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Plasencio, PhD
Phone
9562356315
Email
julieplasencia@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana M Linares, DNS
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Amiga, UK Primary Care Pediatrics, Kentucky Clinic South
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
Polk Dalton Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Linares, PhD
Phone
859-323-4726
Email
am.linares@uky.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to make IPD available upon request.
IPD Sharing Time Frame
At the end of the protocol. Approximately December 2024.
IPD Sharing Access Criteria
Upon request
Citations:
PubMed Identifier
22428352
Citation
Williams JE, Kabukuru A, Mayo R, Griffin SF. Commentary: A social-ecological perspective on obesity among Latinos. Ethn Dis. 2011 Autumn;21(4):467-72.
Results Reference
background
PubMed Identifier
29483202
Citation
Skinner AC, Ravanbakht SN, Skelton JA, Perrin EM, Armstrong SC. Prevalence of Obesity and Severe Obesity in US Children, 1999-2016. Pediatrics. 2018 Mar;141(3):e20173459. doi: 10.1542/peds.2017-3459. Erratum In: Pediatrics. 2018 Sep;142(3):
Results Reference
background
PubMed Identifier
29269386
Citation
Isong IA, Rao SR, Bind MA, Avendano M, Kawachi I, Richmond TK. Racial and Ethnic Disparities in Early Childhood Obesity. Pediatrics. 2018 Jan;141(1):e20170865. doi: 10.1542/peds.2017-0865.
Results Reference
background
PubMed Identifier
28951238
Citation
Beck AL, Hoeft KS, Takayama JI, Barker JC. Beliefs and practices regarding solid food introduction among Latino parents in Northern California. Appetite. 2018 Jan 1;120:381-387. doi: 10.1016/j.appet.2017.09.023. Epub 2017 Sep 23.
Results Reference
background

Learn more about this trial

Latinx Family Wellness

We'll reach out to this number within 24 hrs