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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD096298-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Weight in Pounds | Caregiver 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-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA David Geffen School of Medicine | Los Angeles | California | 90095 | United States |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 6-month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | lbs | 6-months post baseline |
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No adverse events occurred through study completion, on average 10 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alma Guerrero | UCLA DGSOM | 3102672789 | aguerrero@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2022 | Aug 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D000075782 | Cell Phone Use |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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a prospective control group design
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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.
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | child and caregiver age in years | Study included children and caregivers. | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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 | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | The first row relates to the % of Latino children and the second row is related to % of Latino caregivers | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| pounds | The first row are results for children and the second row for caregivers. | Mean | Standard Deviation | lbs |
|
| OG001 | 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. |
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| Secondary | Caregiver Weight in Pounds | Caregiver pounds measured using participant weight measured on a digital scale (calibrated with 5kg weight before each measurement) to the nearest 0.1 pounds | Posted | Mean | Standard Deviation | pounds | 6-months post-intervention |
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|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | 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. | 0 | 64 | 0 | 64 | 0 | 64 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003142 | Communication |
| D001519 | Behavior |
| D012919 | Social Behavior |
| Male |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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