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

NCT02324361 | Completed Results

• 1 other identifier: 2014P000873
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

Pediatric; Obesity; Intervention; Information and Communication Technologies; Social Media; Text Messaging; Mobile Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Sleep

  90 days

• Change in Child Screen Time Exposure

  90 days

• Change in Sugar Sweetened Beverage Intake

  90 days

Study Arms (2)

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.

Other: Physical Activity; Behavioral: Evidence-based information on healthy family routines

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.

Other: Physical Activity; Behavioral: Evidence-based information on healthy family routines

Interventions

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.

Also known as: Change in Physical Activity

Facebook group; Text messaging

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.

Facebook group; Text messaging

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Quincy Pediatric Associates

Quincy, Massachusetts, 02169, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

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.

Results Point of Contact

• Title: Study Project Manager
• Organization: Partners Healthcare

szan@mail.harvard.edu

4259856430

Study Officials

• Kamal Jethwani, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Model Details: 2-arm interventional study

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: December 24, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)