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

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Evidence-based information on healthy family routines
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Pediatric, Obesity, Intervention, Information and Communication Technologies, Social Media, Text Messaging, Mobile Health

Eligibility Criteria

3 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Quincy Pediatric Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Facebook group

Text messaging

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2014
Last Updated
September 27, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02324361
Brief Title
Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study
Acronym
QFYT
Official Title
Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Pediatric, Obesity, Intervention, Information and Communication Technologies, Social Media, Text Messaging, Mobile Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
2-arm interventional study
Masking
None (Open Label)
Masking Description
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.
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Facebook group
Arm Type
Experimental
Arm Description
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.
Arm Title
Text messaging
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Activity
Other Intervention Name(s)
Change in Physical Activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Evidence-based information on healthy family routines
Intervention Description
Educational dimensions include nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours.
Primary Outcome Measure Information:
Title
Parent/Guardian Knowledge of Healthy Family Routines and of Parenting Strategies That Are Preventive of Child Overweight and Obesity
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Change in Sleep
Description
Baseline to 90-days post-intervention change in child sleep duration (hours per day)
Time Frame
90 days
Title
Change in Child Screen Time Exposure
Description
Baseline to 90-days post-intervention change in child screen time exposure (hours per day)
Time Frame
90 days
Title
Change in Sugar Sweetened Beverage Intake
Description
Baseline to 90-days post-intervention change in child sugar sweetened beverage intake (servings per day)
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamal Jethwani, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quincy Pediatric Associates
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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