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

NCT04261985 | Completed Results

• 1 other identifier: 1R21HD096298-01A1
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Obesity; Parenting; Mobile Phone Use

Outcome Measures

Primary Outcomes (1)

• Child Weight

  Child pounds measured using participant weight measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 0.1 pounds

  6-months post baseline

Secondary Outcomes (1)

• Caregiver Weight in Pounds

  6-months post-intervention

Study Arms (2)

Mobile Phone Obesity Intervention

ACTIVE COMPARATOR

Approximately 30 caregiver-child dyads will be randomized into the intervention arm. Every week for 4 weeks, caregivers will receive 4 interactive multi-media phone prompts to support the intervention's targeted topics. Each mobile phone prompt starts with a 140-character text with an embedded link. Clicking on the link navigates caregivers to a web-based application with interactive content that includes images, text, videos, and prompts. Each week, caregivers will share their goal/s, perceived barriers, questions, tips and strategies that may be helpful to other participants. Each week, caregivers will also receive strategies, and individual and group feedback on changing unhealthy behaviors.

Behavioral: healthy weight behaviors supported by web-based mobile phone application

Control

NO INTERVENTION

Approximately 30 caregiver-child dyads will be randomized into the control (no intervention) arm. Every week for 4 weeks, these caregivers will receive 4 interactive multi-media phone prompts around managing common illness in young children (i.e. fever, vomiting, constipation, etc.) Each mobile phone prompt will start with a 140-character text with an embedded link. Clicking on the link navigates caregivers to a web-based application with interactive content that includes images, text, videos, and prompts. Each week, caregivers will share questions and strategies that may be helpful to other participants. Each week, caregivers will also receive tips and group feedback based on group questions.

Interventions

healthy weight behaviors supported by web-based mobile phone application BEHAVIORAL

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 was created in English and Spanish.

Mobile Phone Obesity Intervention

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• child has a failure to thrive diagnosis
• medical complications associated with their weight status such as Prader-Willi Syndrome

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

UCLA David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Cell Phone Use

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication; Behavior; Social Behavior

Results Point of Contact

• Title: Dr. Alma Guerrero
• Organization: UCLA DGSOM

aguerrero@mednet.ucla.edu

3102672789

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A research assistant not working on any other aspect of the study, and therefore having no knowledge of whether participants are in the control or intervention group, will measure child and caregiver height and weight. A 2nd research assistant, who is not blinded to participants, will be responsible for making appointments with participants for height and weight measures.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Pediatrics

Model Details: a prospective control group design

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 10, 2020
• Study Start: June 8, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)