Childhood ObesityNCT02037490
Grow2Gether Pilot Study
A study testing Grow2Gether in people with Childhood Obesity, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial summary
This is a randomized controlled pilot trial of a peer-based, social media intervention to prevent obesity in infants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Grow2Gether
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving prenatal care from Hospital of the University of Pennsylvania (HUP) obstetrics practices
- Age 18 years and older
- Able to provide informed consent
- Able to speak, read and write in English
- Enrolled in Medicaid at the time of study enrollment
- Overweight or obese (BMI ≥ 25, calculated using height and weight recorded at a prenatal visit prior to 14 weeks of pregnancy)
Show all 10Show fewer
- In ≥ 20th week of pregnancy
- Plan to receive their child's primary care services from Children's Hospital of Philadelphia (CHOP) Care Network
- Own a smartphone with both a data and text plan
- Able to use their phone to obtain photographs and videos prior to enrollment
Who cannot join
- Current diagnosis or history of major mental illness, as indicated in medical record by notation of (1) diagnosis or history of condition (2) current use or history of antidepressants or other psychotropic medication, or (3) referral to, or under care of a psychiatrist.
- Multiple pregnancy (twins, triplets, etc.)
- Severe morbidity (significant cardiac disease, significant organ dysfunction, transplant recipient, etc.)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Grow2Gether: Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy
This is a randomized controlled pilot trial of a peer-based, social media intervention to prevent obesity in infants.
Read the detailed description
This novel intervention, delivered to mothers primarily through private Facebook groups, will promote behavior change through peer and self-modeling photo/video activities.
In this study, investigators will implement the intervention with small peer groups of 6-12 mothers, beginning during the 3rd trimester of pregnancy. Investigators will assess feasibility and acceptability of the intervention, and explore its impact on outcomes, particularly behaviors associated with healthy growth.
- Conditions
- Childhood Obesity
- Being tested
- Grow2Gether
- Keywords
- Infants, Mothers, Social media, Obesity prevention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grow2GetherBehavioural
Participants in this intervention will:
Participate in Facebook group of 6-12 peers for about 8 months, led by a professional group mentor.
Complete an intervention video activity approximately weekly:
- View educational videos addressing topics related to healthy infant growth
- Create photos/videos modeling healthy behaviors and post them to the group
- Provide and receive feedback on posts
- Be encouraged to share information with key caregivers of their child
Attend group party soon after enrollment, to meet peers and group leader in person.
| Study group | Role | What they receive |
|---|---|---|
| Grow2Gether Intervention | Experimental | Participants in the intervention group will:
* Participate in the Grow2Gether intervention
* Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network. Receives: Behavioral: Grow2Gether |
| Control | No intervention | Participants in the control group will: * Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability Survey
Satisfaction with the overall intervention will be assessed for mothers using a standard survey. Subjects will be asked a series of open-ended and Likert-scaled questions. Additionally, participants with certain characteristics (such as relatively high or low rates of group participation) will be purposively selected for brief semi-structured interviews based on the survey content to further elucidate their opinion of the intervention.
Measured: After (within 31 days of) the 25th/final week of the postnatal intervention curriculum. (Approximately 8 months from each peer group's start.)
Study population eligibility and interest
- Proportion of all mothers contacted who meet enrollment criteria
- Proportion of mothers meeting enrollment criteria who enroll
These proportions will be calculated using study recruitment records.
Measured: At enrollment
Participant engagement
- Proportion of enrolled mother-infant dyads that comply with intervention participation requirements
- Proportion of enrolled mother-infant dyads that complete each weekly module activity
- Proportion of enrolled mother-infant dyads that complete each study measure
- Number and type of each participant's Facebook group interactions per week (posts, comments, "Likes")
- Frequency, type, and content of each contact between moderator/study staff and each participant
This study process data will be obtained from the Facebook group and study records at study end.
Measured: Ongoing with study activities; to be completed after (within 31 days of) the 25th/final week of the postnatal intervention curriculum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Alexander G. Fiks, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037490
- Sponsor's protocol ID
- 13-010702
- Status last verified
- Jul 2016
- First submitted
- 14 Jan 2014
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grow2Gether: Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy
- ClinicalTrials.gov ID
- NCT02037490
- Acronym / sponsor ID
- 13-010702
- Conditions
- Childhood Obesity
- Keywords
- Infants, Mothers, Social media, Obesity prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled pilot trial of a peer-based, social media intervention to prevent obesity in infants.
Detailed description
This novel intervention, delivered to mothers primarily through private Facebook groups, will promote behavior change through peer and self-modeling photo/video activities.
In this study, investigators will implement the intervention with small peer groups of 6-12 mothers, beginning during the 3rd trimester of pregnancy. Investigators will assess feasibility and acceptability of the intervention, and explore its impact on outcomes, particularly behaviors associated with healthy growth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grow2Gether Intervention | Experimental | Behavioral: Grow2GetherParticipants in the intervention group will: * Participate in the Grow2Gether intervention * Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network. |
| Control | No intervention | –Participants in the control group will: * Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Receiving prenatal care from Hospital of the University of Pennsylvania (HUP) obstetrics practices
- Age 18 years and older
- Able to provide informed consent
- Able to speak, read and write in English
- Enrolled in Medicaid at the time of study enrollment
Key exclusion criteria (3 listed)
- Current diagnosis or history of major mental illness, as indicated in medical record by notation of (1) diagnosis or history of condition (2) current use or history of antidepressants or other psychotropic medication, or (3) referral to, or under care of a psychiatrist.
- Multiple pregnancy (twins, triplets, etc.)
- Severe morbidity (significant cardiac disease, significant organ dysfunction, transplant recipient, etc.)
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 |
|---|---|---|
| Grow2GetherParticipants in this intervention will: Participate in Facebook group of 6-12 peers for about 8 months, led by a professional group mentor. Complete an intervention video activity approximately weekly: 1. View educational videos addressing topics related to healthy infant growth 2. Create photos/videos modeling healthy behaviors and post them to the group 3. Provide and receive feedback on posts 4. Be encouraged to share information with key caregivers of their child Attend group party soon after enrollment, to meet peers and group leader in person. | Behavioural | Grow2Gether Intervention |
Primary outcome
Intervention Acceptability Survey
Time frame: After (within 31 days of) the 25th/final week of the postnatal intervention curriculum. (Approximately 8 months from each peer group's start.)
Satisfaction with the overall intervention will be assessed for mothers using a standard survey. Subjects will be asked a series of open-ended and Likert-scaled questions. Additionally, participants with certain characteristics (such as relatively high or low rates of group participation) will be purposively selected for brief semi-structured interviews based on the survey content to further elucidate their opinion of the intervention.
Study population eligibility and interest
Time frame: At enrollment
* Proportion of all mothers contacted who meet enrollment criteria * Proportion of mothers meeting enrollment criteria who enroll These proportions will be calculated using study recruitment records.
Participant engagement
Time frame: Ongoing with study activities; to be completed after (within 31 days of) the 25th/final week of the postnatal intervention curriculum.
* Proportion of enrolled mother-infant dyads that comply with intervention participation requirements * Proportion of enrolled mother-infant dyads that complete each weekly module activity * Proportion of enrolled mother-infant dyads that complete each study measure * Number and type of each participant's Facebook group interactions per week (posts, comments, "Likes") * Frequency, type, and content of each contact between moderator/study staff and each participant This study process data will be obtained from the Facebook group and study records at study end.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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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.
Alexander G. Fiks, MD, MSCE principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grow2Gether in people with Childhood Obesity, run by Children's Hospital of Philadelphia at 2 sites 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 10 inclusion and 3 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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intervention Acceptability Survey (time frame: After (within 31 days of) the 25th/final week of the postnatal intervention curriculum. (Approximately 8 months from each peer group's start.)). The study lists 3 primary outcomes in all. 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 6 Jul 2016.