Pediatric ObesityQFYTNCT02324361
Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study
A study testing Physical Activity and Evidence-based information on healthy family routines in people with Pediatric Obesity, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Physical Activity and Evidence-based information on healthy family routines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Quincy Pediatric Associates
Quincy, Massachusetts, 02169
About this 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.
Read the 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
- Conditions
- Pediatric Obesity
- Being tested
- Physical Activity, Evidence-based information on healthy family routines
- Keywords
- Pediatric, Obesity, Intervention, Information and Communication Technologies, Social Media, Text Messaging, Mobile Health
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityOther
Also called Change in 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.
Evidence-based information on healthy family routinesBehavioural
Educational dimensions include nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physical Activity; Behavioral: Evidence-based information on healthy family routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (3)
Change in Sleep
Baseline to 90-days post-intervention change in child sleep duration (hours per day)
Measured: 90 days
Change in Child Screen Time Exposure
Baseline to 90-days post-intervention change in child screen time exposure (hours per day)
Measured: 90 days
Change in Sugar Sweetened Beverage Intake
Baseline to 90-days post-intervention change in child sugar sweetened beverage intake (servings per day)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 2-arm interventional study
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph C. Kvedar, Massachusetts General Hospital
- Investigators
- Kamal Jethwani, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324361
- Sponsor's protocol ID
- 2014P000873
- Acronym
- QFYT
- Status last verified
- Sep 2020
- First submitted
- 7 Jul 2014
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quincy Family, Youth & Technology For Lifestyle Change (FYT-4-LIFE) Study
- ClinicalTrials.gov ID
- NCT02324361
- Acronym / sponsor ID
- QFYT / 2014P000873
- Conditions
- Pediatric Obesity
- Keywords
- Pediatric, Obesity, Intervention, Information and Communication Technologies, Social Media, Text Messaging, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-arm interventional study
| Arm | Type | Receives |
|---|---|---|
| Facebook group | Experimental | Other: Physical Activity, Behavioral: Evidence-based information on healthy family routinesThe 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. |
| Text messaging | Experimental | Other: Physical Activity, Behavioral: Evidence-based information on healthy family routinesThe 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. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
- Is 18 years or older
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityAlso: Change in Physical ActivityThe 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 | Facebook group, Text messaging |
| Evidence-based information on healthy family routinesEducational dimensions include nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours. | Behavioural | Facebook group, Text messaging |
Primary outcome
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.
3 secondary outcomes
Change in Sleep
Time frame: 90 days
Change in Child Screen Time Exposure
Time frame: 90 days
Change in Sugar Sweetened Beverage Intake
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal Jethwani, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity and Evidence-based information on healthy family routines in people with Pediatric Obesity, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent/Guardian Knowledge of Healthy Family Routines and of Parenting Strategies That Are Preventive of Child Overweight and Obesity (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.