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To date, approaches that show the most promise for preventing and/or reversing the course of childhood obesity involve the delivery of intensive lifestyle interventions within a family-based context, emphasizing the necessity of parental involvement and making changes in family routines and the home environment. Considering that the current demand for pediatric weight management programs far exceed availability, as well as the high attrition rates observed in such programs, there is a great need for more accessible and efficient means of delivering these interventions to reduce the burden of childhood obesity.
The goal of this study is to understand whether text messaging and social media platforms can be leveraged to address the important issue of childhood obesity by engaging parent/guardians in one of these strategies, and whether these strategies produce similar outcomes. No existing study has compared these strategies head-to-head, and the investigators believe that this project will be instrumental in understanding the determinants of success in these strategies and allow us to collect sufficient intelligence to be able to deploy these meaningfully to patients as part of usual care.
The goal of this pilot study is to evaluate and compare the feasibility and effectiveness of two platforms, text messaging and Facebook, for delivering an evidence-based, family-centric childhood obesity intervention to parent/guardians of children between the ages of 3-6 with a BMI of 90th percentile and above. The investigators hypothesize that the use of both platforms for delivering a childhood obesity intervention will help establish healthier family routines and be equally engaging and accepted by parent/guardians and children.
The primary aim of this study is to assess the effect of the intervention on:
The secondary aims of the study are to assess the effect of the intervention on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facebook group | Experimental | The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for Facebook posts on a private study Facebook group. Participating parents/guardians will have access to all features of the secret study Facebook group (e.g., create and view postings, comment and like existing posts and view user names of other members of the group (existing study participants and staff) for the duration of the study. All index children will be provided with a Physical Activity Monitor to wear during waking hours for the duration of the study. |
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| Text messaging | Experimental | The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages. The automated text-messaging algorithm consists of the delivery of two types of text messages: 1-way messages, in which participating parents/guardians will receive a piece of education or motivation on the dimension topic that they're being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on. All index children will be provided with a Physical Activity Monitor to wear during waking hours for the duration of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity | Other | The Fitbit Zip is a wireless physical activity monitor that will be worn by the index child during waking hours, and will be used to assess daily active time for the duration of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Parent/Guardian Knowledge of Healthy Family Routines and of Parenting Strategies That Are Preventive of Child Overweight and Obesity | We designed a scale for use in this study containing 8 questions on each of the family routines that we assessed (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours). Each of the eight questions were assigned one point value. The scale was summative such that the lowest possible score was 0 and highest possible score was 8, from adding up scores to all eight questions. Higher scores indicated a better outcome. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep | Baseline to 90-days post-intervention change in child sleep duration (hours per day) | 90 days |
| Change in Child Screen Time Exposure | Baseline to 90-days post-intervention change in child screen time exposure (hours per day) |
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Inclusion Criteria:
The participating parent/guardian:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamal Jethwani, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quincy Pediatric Associates | Quincy | Massachusetts | 02169 | United States |
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Caregivers were phone-screened for English fluency, internet access, computer/smartphone ownership, and ownership of a Facebook account. Those with significant functional impairments or co-morbidities, those enrolled in another weight management intervention program, or had a sibling already enrolled in the study were excluded from participation.
From July to October 2014, attempts were made to solicit the participation of primary caregivers of all children receiving care since 2013 at Quincy Pediatric Associates (QPA) via mailed recruitment letters.
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| ID | Title | Description |
|---|---|---|
| FG000 | Facebook Group | The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group. All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study. |
| FG001 | Text Messaging (SMS) Group | The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages. The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on. All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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1 participant from the Facebook group was unresponsive to contact and subsequently omitted from baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Facebook Group | The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for Facebook posts on a private study Facebook group. Participating parents/guardians will have access to all features of the secret study Facebook group (e.g., create and view postings, comment and like existing posts and view user names of other members of the group (existing study participants and staff) for the duration of the study. All index children will be provided with a Physical Activity Monitor to wear during waking hours for the duration of the study. |
| 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, Continuous | Age of caregiver |
| 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 | Parent/Guardian Knowledge of Healthy Family Routines and of Parenting Strategies That Are Preventive of Child Overweight and Obesity | We designed a scale for use in this study containing 8 questions on each of the family routines that we assessed (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours). Each of the eight questions were assigned one point value. The scale was summative such that the lowest possible score was 0 and highest possible score was 8, from adding up scores to all eight questions. Higher scores indicated a better outcome. | Posted | Mean | 95% Confidence Interval | units on a scale | 90 days |
|
90 days, over the entire duration of the study
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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 | Facebook Group | The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group. All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study. |
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Having participants self-select the technology platform used to deliver an mHealth intervention may promote intervention engagement this lack of randomization potentially limits the generalizability of the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Project Manager | Partners Healthcare | 4259856430 | szan@mail.harvard.edu |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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2-arm interventional study
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Participants were given a choice to select one of the two interventions, which were made clear to them. There was no masking of the study.
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|
| Evidence-based information on healthy family routines | Behavioral | Educational dimensions include nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours. |
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| 90 days |
| Change in Sugar Sweetened Beverage Intake | Baseline to 90-days post-intervention change in child sugar sweetened beverage intake (servings per day) | 90 days |
| BG001 | Text Messaging | The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages. The automated text-messaging algorithm consists of the delivery of two types of text messages: 1-way messages, in which participating parents/guardians will receive a piece of education or motivation on the dimension topic that they're being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Age, Continuous | Age of index child | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Sex of index child | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Caregiver ethnicity | Count of Participants | Participants |
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| Race (NIH/OMB) | Caregiver race | Count of Participants | Participants |
|
| OG001 | Text Messaging (SMS) Group | The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages. The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on. All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study. |
|
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| Secondary | Change in Sleep | Baseline to 90-days post-intervention change in child sleep duration (hours per day) | Posted | Mean | 95% Confidence Interval | hours per day | 90 days |
|
|
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| Secondary | Change in Child Screen Time Exposure | Baseline to 90-days post-intervention change in child screen time exposure (hours per day) | Posted | Mean | 95% Confidence Interval | hours per day | 90 days |
|
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| Secondary | Change in Sugar Sweetened Beverage Intake | Baseline to 90-days post-intervention change in child sugar sweetened beverage intake (servings per day) | Posted | Mean | 95% Confidence Interval | servings per day | 90 days |
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| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Text Messaging (SMS) Group | The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages. The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on. All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study. | 0 | 24 | 0 | 24 | 0 | 24 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |