Clinical trial NCT02324361: Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study
Official title: Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Pediatric
Obesity
Intervention
Information and Communication Technologies
Social Media
Text Messaging
Mobile Health
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 2-arm interventional study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

* Parent/guardian knowledge of healthy family routines (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours) and of parenting strategies that are preventive of child overweight and obesity
* Parent/guardian readiness, confidence, and perceived self-efficacy to make and maintain changes in family routines known to be associated with healthy weight outcomes

The secondary aims of the study are to assess the effect of the intervention on:

* The adoption of healthy family routines and parenting strategies that are preventive of child overweight and obesity
* Daily objective physical activity in the index child by accelerometry (using a physical activity tracking device)
* Index children's BMI percentile, using data collected during regular clinic visits from the electronic medical record
* To assess the level of engagement with the intervention, measured via daily activity tracker wear by the index child, parent/guardian views of Facebook posts or responses to 2-way text messages

Eligibility criteria: Inclusion Criteria:

* Index child's BMI ≥90th percentile
* Index child age between 3 and 7 years of age at time of enrollment in study
* The child is under the care of a primary care provider at the Quincy Pediatric Associates practice
* The family is not planning to move from the Greater Boston area during the study period

The participating parent/guardian:

* Is 18 years or older
* Is the primary caregiver for the child
* Has regular access to the Internet
* Has regular access to a personal computer with USB connection OR a smartphone with a mobile operating system that is compatible with the physical activity tracker
* Owns a Facebook account AND a cellphone with text messaging capability and if choosing the text-messaging intervention, is willing to receive a maximum of 62 text messages/month for 3 months on their personal cellphone
* Is fluent in English (spoken and written)

Exclusion Criteria:

* Children who are diagnosed with underlying medical or pharmacologic factors that may contribute to obesity and/or affect participation in physical activity
* Significant medical or psychiatric co-morbidities in the participating parent/guardian
* Visual, hearing, or cognitive impairments in the participating parent/guardian
* Index child or parent/guardian currently enrolled in another weight control program
* Children who have a sibling already enrolled in the study

Primary outcomes:
measure: Parent/Guardian Knowledge of Healthy Family Routines and of Parenting Strategies That Are Preventive of Child Overweight and Obesity
timeFrame: 90 days
Secondary outcomes:
measure: Change in Sleep
timeFrame: 90 days
measure: Change in Child Screen Time Exposure
timeFrame: 90 days
measure: Change in Sugar Sweetened Beverage Intake
timeFrame: 90 days
Other outcomes:
Locations:
city: Quincy
country: United States
facility: Quincy Pediatric Associates
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Kamal Jethwani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: