Childhood ObesityNCT01977105
Healthy Growth Abbreviated Pilot Study
A study testing Grow Together peer group in people with Childhood Obesity, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This is a single-group feasibility 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?
- Grow Together peer group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2013
- 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
- Women age 18 years and older
- Enrolled in Medicaid at the time of study enrollment
- Overweight or obese (BMI >= 25, calculated using self-reported pre-pregnancy height and weight)
- Subjects able to speak, read and write in English
- Attend their infant's (up to 1 month old) primary care visit at a CHOP Primary Care Network site
- Received prenatal care
- 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
- Cannot provide consent.
- Non-English speaking.
- Score 10 or greater on Patient Health Questionnaire (PHQ-9) measure for clinical depression
- Diagnosed with gestational diabetes during pregnancy with their newborn
- Had a multiple pregnancy.
- Premature delivery (before 37 weeks) of their newborn.
- Have a newborn who was hospitalized in the Neonatal Intensive Care Unit (NICU) for one week or longer.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Abbreviated Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy
This is a single-group feasibility 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, we will implement an abbreviated 2-month version of the intervention with a single peer group of up to 10 mothers. We will assess the feasibility and acceptability of both the intervention and our intended outcome measures, in preparation for a randomized pilot trial of the full intervention.
- Conditions
- Childhood Obesity
- Being tested
- Grow Together peer group
- 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.
Grow Together peer groupBehavioural
Participants in this intervention will:
- Participate in Facebook group of 6-10 peers for about 8 weeks, 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.
- Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network.
- Have basic program information provided to pediatrician to enhance conversation during office visits.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Intervention Group | Experimental | Mothers who are screened and determined to be eligible for this single-group pilot study will be enrolled along with their infants in the Grow Together peer group intervention. Receives: Behavioral: Grow Together peer group |
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.
Measured: Study end (approximately 2 months)
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: Study end (approximately 2 months)
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: Study end (approximately 2 months)
Week 1 Curriculum Module Acceptability Survey
Subjects will assess the Week 1 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Measured: 1 week (approximately)
Week 2 Curriculum Module Acceptability Survey
Subjects will assess the Week 2 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Measured: 2 weeks (approximately)
Week 3 Curriculum Module Acceptability Survey
Subjects will assess the Week 3 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Measured: 3 weeks (approximately)
Week 4 Curriculum Module Acceptability Survey
Subjects will assess the Week 4 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Measured: 4 weeks (approximately)
Week 5 Curriculum Module Acceptability Survey
Subjects will assess the Week 5 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Measured: 5 weeks (approximately)
Week 6 Curriculum Module Acceptability Survey
Subjects will assess the Week 6 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Measured: 6 weeks (approximately)
Week 7 Curriculum Module Acceptability Survey
Subjects will assess the Week 7 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Measured: 7 weeks (approximately)
Week 8 Curriculum Module Acceptability Survey
Subjects will assess the Week 8 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Measured: 8 weeks (approximately)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander G Fiks, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977105
- Sponsor's protocol ID
- 12-009905
- Status last verified
- Feb 2014
- First submitted
- 30 Sep 2013
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gruver RS, Bishop-Gilyard CT, Lieberman A, Gerdes M, Virudachalam S, Suh AW, Kalra GK, Magge SN, Shults J, Schreiner MS, Power TJ, Berkowitz RI, Fiks AG. A Social Media Peer Group Intervention for Mothers to Prevent Obesity and Promote Healthy Growth from Infancy: Development and Pilot Trial. JMIR Res Protoc. 2016 Aug 2;5(3):e159. doi: 10.2196/resprot.5276.
PubMed 27485934
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abbreviated Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy
- ClinicalTrials.gov ID
- NCT01977105
- Acronym / sponsor ID
- 12-009905
- Conditions
- Childhood Obesity
- Keywords
- Infants, Mothers, Social media, Obesity prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Nov 2013 (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 single-group feasibility 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, we will implement an abbreviated 2-month version of the intervention with a single peer group of up to 10 mothers. We will assess the feasibility and acceptability of both the intervention and our intended outcome measures, in preparation for a randomized pilot trial of the full intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Intervention Group | Experimental | Behavioral: Grow Together peer groupMothers who are screened and determined to be eligible for this single-group pilot study will be enrolled along with their infants in the Grow Together peer group intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women age 18 years and older
- Enrolled in Medicaid at the time of study enrollment
- Overweight or obese (BMI >= 25, calculated using self-reported pre-pregnancy height and weight)
- Subjects able to speak, read and write in English
- Attend their infant's (up to 1 month old) primary care visit at a CHOP Primary Care Network site
Key exclusion criteria (7 listed)
- Cannot provide consent.
- Non-English speaking.
- Score 10 or greater on Patient Health Questionnaire (PHQ-9) measure for clinical depression
- Diagnosed with gestational diabetes during pregnancy with their newborn
- Had a multiple pregnancy.
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 |
|---|---|---|
| Grow Together peer groupParticipants in this intervention will: * Participate in Facebook group of 6-10 peers for about 8 weeks, 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. * Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network. * Have basic program information provided to pediatrician to enhance conversation during office visits. | Behavioural | Pilot Intervention Group |
Primary outcome
Intervention Acceptability Survey
Time frame: Study end (approximately 2 months)
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.
Study population eligibility and interest
Time frame: Study end (approximately 2 months)
* 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: Study end (approximately 2 months)
* 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.
Week 1 Curriculum Module Acceptability Survey
Time frame: 1 week (approximately)
Subjects will assess the Week 1 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 2 Curriculum Module Acceptability Survey
Time frame: 2 weeks (approximately)
Subjects will assess the Week 2 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 3 Curriculum Module Acceptability Survey
Time frame: 3 weeks (approximately)
Subjects will assess the Week 3 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 4 Curriculum Module Acceptability Survey
Time frame: 4 weeks (approximately)
Subjects will assess the Week 4 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 5 Curriculum Module Acceptability Survey
Time frame: 5 weeks (approximately)
Subjects will assess the Week 5 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 6 Curriculum Module Acceptability Survey
Time frame: 6 weeks (approximately)
Subjects will assess the Week 6 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 7 Curriculum Module Acceptability Survey
Time frame: 7 weeks (approximately)
Subjects will assess the Week 7 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
Week 8 Curriculum Module Acceptability Survey
Time frame: 8 weeks (approximately)
Subjects will assess the Week 8 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
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 Feb 2014.
- Derived from this study: PubMed 27485934Gruver RS, Bishop-Gilyard CT, Lieberman A, Gerdes M, Virudachalam S, Suh AW, Kalra GK, Magge SN, Shults J, Schreiner MS, Power TJ, Berkowitz RI, Fiks AG. A Social Media Peer Group Intervention for Mothers to Prevent Obesity and Promote Healthy Growth from Infancy: Development and Pilot Trial. JMIR Res Protoc. 2016 Aug 2;5(3):e159. doi: 10.2196/resprot.5276.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grow Together peer group in people with Childhood Obesity, run by Children's Hospital of Philadelphia 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 8 inclusion and 7 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 Feb 2014. 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?
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: Study end (approximately 2 months)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01977105, which also lists 1 linked publication.
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 Feb 2014; AzTrials last refreshed its copy on 28 Oct 2026.