Trial Outcomes & Findings for A Mobile Phone Based Pilot Intervention to Prevent Obesity in Latino Preschool Children (NCT NCT04261985)

NCT ID: NCT04261985

Last Updated: 2024-10-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

59 participants

Primary outcome timeframe

6-months post baseline

Results posted on

2024-10-16

Participant Flow

This study set out to enroll 60 parent-child dyads. Every parent-child dyad consists of one child between 2-years old and 5-years old and the child's primary caregiver. We, therefore, set out to enroll a total of 120 participants (60 children and 60 caregivers).

Participant milestones

Participant milestones
Measure	Mobile Phone Obesity Intervention Caregiver-child dyads will be recruited from two early childhood education centers in East Los Angeles. 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. The content shared by caregivers are summarized by a team research assistant and sent back to participants at the end of every week. 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.	Control Caregiver-child dyads will be recruited from two early childhood education centers in East Los Angeles. 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. The content shared by caregivers will be summarized by a team research assistant and sent back to participants at the end of every week.
Baseline STARTED	54	64
Baseline COMPLETED	54	64
Baseline NOT COMPLETED	0	0
6-month Follow-up STARTED	54	64
6-month Follow-up COMPLETED	52	62
6-month Follow-up NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study included children and caregivers.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6-months post baseline

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

Outcome measures

Outcome measures
Measure	Mobile Phone Obesity Intervention n=26 Participants Caregiver-child dyads will be recruited from two early childhood education centers in East Los Angeles. 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. The content shared by caregivers are summarized by a team research assistant and sent back to participants at the end of every week. 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.	Control n=31 Participants Caregiver-child dyads will be recruited from two early childhood education centers in East Los Angeles. 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. The content shared by caregivers will be summarized by a team research assistant and sent back to participants at the end of every week.
Child Weight	45.6 lbs Standard Deviation 9.7	44.9 lbs Standard Deviation 8.6

SECONDARY outcome

Timeframe: 6-months post-intervention

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

Outcome measures

Outcome measures
Measure	Mobile Phone Obesity Intervention n=26 Participants Caregiver-child dyads will be recruited from two early childhood education centers in East Los Angeles. 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. The content shared by caregivers are summarized by a team research assistant and sent back to participants at the end of every week. 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.	Control n=31 Participants Caregiver-child dyads will be recruited from two early childhood education centers in East Los Angeles. 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. The content shared by caregivers will be summarized by a team research assistant and sent back to participants at the end of every week.
Caregiver Weight in Pounds	176.9 pounds Standard Deviation 35.1	178.3 pounds Standard Deviation 32.9

Adverse Events

Mobile Phone Obesity Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alma Guerrero

UCLA DGSOM

Phone: 3102672789

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Mobile Phone Obesity Intervention n=54 Participants Caregiver-child dyads will be recruited from two early childhood education centers in East Los Angeles. 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. The content shared by caregivers are summarized by a team research assistant and sent back to participants at the end of every week. 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.	Control n=64 Participants Caregiver-child dyads will be recruited from two early childhood education centers in East Los Angeles. 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. The content shared by caregivers will be summarized by a team research assistant and sent back to participants at the end of every week.	Total n=118 Participants Total of all reporting groups
Age, Categorical <=18 years	27 Participants n=54 Participants	32 Participants n=64 Participants	59 Participants n=118 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=54 Participants	32 Participants n=64 Participants	59 Participants n=118 Participants
Age, Categorical >=65 years	0 Participants n=54 Participants	0 Participants n=64 Participants	0 Participants n=118 Participants
Age, Continuous Children	4.0 years STANDARD_DEVIATION 0.9 • n=27 Participants • Study included children and caregivers.	4.1 years STANDARD_DEVIATION 0.8 • n=32 Participants • Study included children and caregivers.	4.0 years STANDARD_DEVIATION 0.9 • n=59 Participants • Study included children and caregivers.
Age, Continuous Caregivers	32.3 years STANDARD_DEVIATION 8.6 • n=27 Participants • Study included children and caregivers.	35.2 years STANDARD_DEVIATION 7.6 • n=32 Participants • Study included children and caregivers.	34 years STANDARD_DEVIATION 8.2 • n=59 Participants • Study included children and caregivers.
Sex: Female, Male children · Female	15 Participants n=27 Participants • The first row is the % of male and females of children in the study, the second row is % of male and females of caregivers in study	16 Participants n=32 Participants • The first row is the % of male and females of children in the study, the second row is % of male and females of caregivers in study	31 Participants n=59 Participants • The first row is the % of male and females of children in the study, the second row is % of male and females of caregivers in study
Sex: Female, Male children · Male	12 Participants n=27 Participants • The first row is the % of male and females of children in the study, the second row is % of male and females of caregivers in study	16 Participants n=32 Participants • The first row is the % of male and females of children in the study, the second row is % of male and females of caregivers in study	28 Participants n=59 Participants • The first row is the % of male and females of children in the study, the second row is % of male and females of caregivers in study
Sex: Female, Male caregivers · Female	26 Participants n=27 Participants • The first row is the % of male and females of children in the study, the second row is % of male and females of caregivers in study	29 Participants n=32 Participants • The first row is the % of male and females of children in the study, the second row is % of male and females of caregivers in study	55 Participants n=59 Participants • The first row is the % of male and females of children in the study, the second row is % of male and females of caregivers in study
Sex: Female, Male caregivers · Male	1 Participants n=27 Participants • The first row is the % of male and females of children in the study, the second row is % of male and females of caregivers in study	3 Participants n=32 Participants • The first row is the % of male and females of children in the study, the second row is % of male and females of caregivers in study	4 Participants n=59 Participants • The first row is the % of male and females of children in the study, the second row is % of male and females of caregivers in study
Ethnicity (NIH/OMB) Children · Hispanic or Latino	27 Participants n=27 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers	32 Participants n=32 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers	59 Participants n=59 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers
Ethnicity (NIH/OMB) Children · Not Hispanic or Latino	0 Participants n=27 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers	0 Participants n=32 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers	0 Participants n=59 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers
Ethnicity (NIH/OMB) Children · Unknown or Not Reported	0 Participants n=27 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers	0 Participants n=32 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers	0 Participants n=59 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers
Ethnicity (NIH/OMB) Caregivers · Hispanic or Latino	27 Participants n=27 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers	32 Participants n=32 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers	59 Participants n=59 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers
Ethnicity (NIH/OMB) Caregivers · Not Hispanic or Latino	0 Participants n=27 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers	0 Participants n=32 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers	0 Participants n=59 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers
Ethnicity (NIH/OMB) Caregivers · Unknown or Not Reported	0 Participants n=27 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers	0 Participants n=32 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers	0 Participants n=59 Participants • The first row relates to the % of Latino children and the second row is related to % of Latino caregivers
Region of Enrollment United States	54 participants n=54 Participants	64 participants n=64 Participants	118 participants n=118 Participants
pounds Children	41.1 lbs STANDARD_DEVIATION 7.9 • n=27 Participants • The first row are results for children and the second row for caregivers.	40.4 lbs STANDARD_DEVIATION 7.3 • n=32 Participants • The first row are results for children and the second row for caregivers.	40.6 lbs STANDARD_DEVIATION 7.6 • n=59 Participants • The first row are results for children and the second row for caregivers.
pounds Caregivers	171 lbs STANDARD_DEVIATION 35.6 • n=27 Participants • The first row are results for children and the second row for caregivers.	176 lbs STANDARD_DEVIATION 35.6 • n=32 Participants • The first row are results for children and the second row for caregivers.	173 lbs STANDARD_DEVIATION 33.1 • n=59 Participants • The first row are results for children and the second row for caregivers.