Clinical trial NCT05735600: Latinx Family Wellness
Official title: Leveraging Cultural Health Beliefs and Actions to Improve Latinx Family Wellness
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Childhood Obesity
Keywords: Childhood Obesity
Latinx
Intervention
Deep level education
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Kentucky
First posted: 2023-02-21
Enrollment: 57
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in scores of the Child Feeding Questionnaire
timeFrame: Baseline and at 1, 3, and 6 months.
measure: Change in scores of the Caregiver's Feeding Style Questionnaire
timeFrame: Baseline and at 1, 3, and 6 months.
measure: Recruitment for AyUDA
timeFrame: From study start until enrollment closes up to 9 months.
measure: Intervention completion for AyUDA.
timeFrame: From enrollment to end of intervention at 6 weeks
measure: Retention for AyUDA.
timeFrame: From enrollment to end of study at 8 months
Secondary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and at 6 months after the intervention.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Clinica Amiga, UK Primary Care Pediatrics, Kentucky Clinic South
state: Kentucky
city: Lexington
country: United States
facility: Polk Dalton Clinic
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Ana M Linares, DNS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.