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Completed

NCT Number: NCT02324361

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

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.

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Quincy Pediatric Associates

Quincy, Massachusetts, 02169, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Change in Physical Activity

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.

Primary outcomes

  1. Parent/Guardian Knowledge of Healthy Family Routines and of Parenting Strategies That Are Preventive of Child Overweight and Obesity

    Time frame: 90 days

    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 outcomes

  1. Change in Sleep

    Time frame: 90 days

    Baseline to 90-days post-intervention change in child sleep duration (hours per day)

  2. Change in Child Screen Time Exposure

    Time frame: 90 days

    Baseline to 90-days post-intervention change in child screen time exposure (hours per day)

  3. Change in Sugar Sweetened Beverage Intake

    Time frame: 90 days

    Baseline to 90-days post-intervention change in child sugar sweetened beverage intake (servings per day)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: QFYT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2014
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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