Childhood Obesity, Mobile Phone Use, Parenting
Conditions
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.
Detailed 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.
Interventions
BEHAVIORALhealthy 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 was created in English and Spanish.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
a prospective control group design
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Weight | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Weight in Pounds | 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 |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 54 |
| 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. | 64 |
| Total | 118 |
Baseline characteristics
| Characteristic | Mobile Phone Obesity Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 27 Participants | 32 Participants | 59 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 32 Participants | 59 Participants |
| Age, Continuous Caregivers | 32.3 years STANDARD_DEVIATION 8.6 | 35.2 years STANDARD_DEVIATION 7.6 | 34 years STANDARD_DEVIATION 8.2 |
| Age, Continuous Children | 4.0 years STANDARD_DEVIATION 0.9 | 4.1 years STANDARD_DEVIATION 0.8 | 4.0 years STANDARD_DEVIATION 0.9 |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 27 Participants | 32 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Children Hispanic or Latino | 27 Participants | 32 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Children Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Children Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| pounds Caregivers | 171 lbs STANDARD_DEVIATION 35.6 | 176 lbs STANDARD_DEVIATION 35.6 | 173 lbs STANDARD_DEVIATION 33.1 |
| pounds Children | 41.1 lbs STANDARD_DEVIATION 7.9 | 40.4 lbs STANDARD_DEVIATION 7.3 | 40.6 lbs STANDARD_DEVIATION 7.6 |
| Region of Enrollment United States | 54 participants | 64 participants | 118 participants |
| Sex: Female, Male caregivers Female | 26 Participants | 29 Participants | 55 Participants |
| Sex: Female, Male caregivers Male | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male children Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male children Male | 12 Participants | 16 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 64 |
| other Total, other adverse events | 0 / 54 | 0 / 64 |
| serious Total, serious adverse events | 0 / 54 | 0 / 64 |
Outcome results
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
Time frame: 6-months post baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Phone Obesity Intervention | Child Weight | 45.6 lbs | Standard Deviation 9.7 |
| Control | Child Weight | 44.9 lbs | Standard Deviation 8.6 |
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
Time frame: 6-months post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Phone Obesity Intervention | Caregiver Weight in Pounds | 176.9 pounds | Standard Deviation 35.1 |
| Control | Caregiver Weight in Pounds | 178.3 pounds | Standard Deviation 32.9 |