Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study

Pediatric Obesity Clinical Trial

— QFYT  

Official title:

Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324361
• Other study ID #: 2014P000873
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: February 2015

Study information

• Verified date: September 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Other:
• Physical Activity
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.

Behavioral:
• Evidence-based information on healthy family routines
Educational dimensions include nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours.

Locations

Country	Name	City	State
United States	Quincy Pediatric Associates	Quincy	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	90 days
Secondary	Change in Sleep	Baseline to 90-days post-intervention change in child sleep duration (hours per day)	90 days
Secondary	Change in Child Screen Time Exposure	Baseline to 90-days post-intervention change in child screen time exposure (hours per day)	90 days
Secondary	Change in Sugar Sweetened Beverage Intake	Baseline to 90-days post-intervention change in child sugar sweetened beverage intake (servings per day)	90 days