A Mobile Phone Based Pilot Intervention to Prevent Obesity in Latino Preschool Children

Childhood Obesity Clinical Trial

Official title:

A Mobile Phone Based Pilot Intervention to Prevent Obesity in Latino Preschool Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04261985
• Other study ID #: 1R21HD096298-01A1
• Secondary ID: 1R21HD096298-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2020
• Source: University of California, Los Angeles
• Contact: Alma Guerrero, MD, MPH
• Phone: 310-267-2789
• Email: aguerrero[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To pilot a stand-alone mobile phone intervention with Latino caregivers of 2- to 5-year olds, using a prospective control group design, to assess feasibility and preliminary effect sizes on children's BMI changes (primary outcome) and dietary and physical activity changes (secondary outcomes) at 6 months post-baseline, in preparation for a larger randomized trial to evaluate the intervention's efficacy.

Description:

The investigators will pilot an mHealth intervention using a prospective control group design with 66 caregiver-child dyads (33 intervention and 33 comparison) recruited from two community based agencies in East Los Angeles. Fidelity and feasibility will be assessed. Pre- and post- intervention data (child dietary, physical activity, and media viewing behaviors and BMI z-scores) will be collected to estimate preliminary effect sizes and standard deviations. The mHealth intervention has been informed by a previous feasibility study and focus groups with Latino caregivers of 2- to 5-year old children. This mHealth childhood obesity intervention specifically targets Latino mothers, fathers, and grandmothers of 2- to 5-year olds. The intervention focuses on parenting skills, dietary, physical activity, and media-viewing behaviors consistent with American Academy of Pediatrics guidelines.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult male or female caregiver

• self-identifies as an individual of Latino descent

• has a child or grandchild 2-5 years of age (relationship does not have to be biological but caregiver is a legal guardian)

• lives with or cares for child/grandchild at least 20 hours/week

• is fluent in English or Spanish

• has the ability to participate in the mHealth intervention (ability determined by using a Subject Comprehension and Participation Assessment Tool)

• agrees to complete baseline, 1-, and 6-month post-baseline surveys and have adult and child height and weight measured.

Exclusion Criteria:

• child has a failure to thrive diagnosis

• medical complications associated with their weight status such as Prader-Willi Syndrome

Related Conditions & MeSH terms

• Childhood Obesity
• Mobile Phone Use
• Obesity
• Parenting
• Pediatric Obesity

Intervention

Behavioral:
• healthy weight behaviors supported by web-based mobile phone application
Chorus is a mobile phone platform that provides texting, a web application, and an online community for mHealth interventions.Content is created using existing templates to insert text, images, pictures, audio, video clips, or any combination of these. Users interface with Chorus by clicking a hyperlink embedded in a text message sent to their phone to then access web-based interactions via prompts and clicks. Content is available in English and Spanish.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child BMI (BMI=kg/m2)	Child BMI will be calculated using participant weight in Kilograms measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 100 grams and height measured to the nearest 0.1cm using a stadiometer	6-months post intervention
Secondary	caregiver BMI (BMI=kg/m2)	Caregiver BMI will be calculated using participant weight in Kilograms measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 100 grams and height measured to the nearest 0.1cm using a stadiometer	6-months post-intervention
Secondary	Children's Dietary Behaviors	Children's Dietary Questionnaire (29-item instrument) measures a child's average consumption of 4 categories of foods or beverages. The 4 categories are further divided into 4 separate scores: a fruits and vegetables score, a fat from dairy products score, a sweetened beverage score, and a noncore food. Items are measured by participants responding to frequency/counts or using a likert scale. There are cutoffs provided for each score of the 4 categories. Overall, the higher the score in the fruits and vegetable sections the healthier the dietary behavior and the higher the score on dairy from fat and noncore foods the unhealthier the diet.; score	6-months post intervention
Secondary	Child media-viewing behaviors	Home Environment Inventory Survey: measures hours of watching TV, DVDs or Computer using two questions with responses including hours spent from three time categories throughout the day. The higher the number of hours reported the unhealthier the media-viewing behavior.	6-months post intervention
Secondary	Child physical activity behaviors	Outdoor Playtime Checklist : the items on the scale ask two questions with responses from five time interval categories that are coded 0 through 4. The ordered categorical responses and summing the responses across both questions gives a maximum score of 24. The higher the score the more time spent playing outdoors.	6-months post intervention