ObesityNCT04216264
Pattern - Reach Aim 2
A study testing Standard response and Targeted response in people with Obesity, run by Duke University at 1 site in United States.
Trial summary
The purpose of this research study is to learn about different approaches to promoting healthy growth among infants, and understanding parents' likes and dislikes of an approach to reducing risk factors for obesity later in life. Read more about this study
- Who is it for?
- Ages 2 weeks to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Standard response and Targeted response
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2020to 4 May 2021
- 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 2 weeks to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Non-Hispanic black (as documented in MaestroCare) parents/caregivers with; infants ages 2 weeks to 2 months of age; infant birthweight between 2500g and 4000g; infant gestational age is at least 36 weeks
Who cannot join
- non-English-speaking; infant with serious disease or disorder affecting growth and nutrition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Adaptive Tool To Encourage Risk Reduction in iNfancy (PATTERN)
The purpose of this research study is to learn about different approaches to promoting healthy growth among infants, and understanding parents' likes and dislikes of an approach to reducing risk factors for obesity later in life. The study includes filling out some forms with questions about your baby and your thoughts about your baby's growth and health, and engaging in a pattern of changes in or prevention of risk factors in the first year of life. Parents will receive information about changes and some tools and materials to take home with them. Some parents may receive phone calls between visits as well. The study takes place from soon after birth through the infant's age of 9 months. The estimated total time of interaction between the study staff and parents during the study period is 4 hours.
Read the detailed description
As this is a dyad study, each dyad is considered to be a participant and demographic information will reflect the infant in the dyad, per parent report.
- Conditions
- Obesity
- Being tested
- Standard response, Targeted response
- Keywords
- infant, mother-baby
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard responseBehavioural
Parents pick from a menu of behavior changes
Targeted responseBehavioural
Stepped up phone interaction with parents based on menu of behavior changes
| Study group | Role | What they receive |
|---|---|---|
| Response | Other | Not described Receives: Behavioral: Standard response |
| Non-response | Other | Not described Receives: Behavioral: Targeted response |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire
Completed Likert scale with 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5=very satisfied
Measured: 3 to 6 months after baseline assessment
Percentage of Successful Contacts With Families Via Telephone and/or in Clinic
Number of successful contacts with families divided by number of attempts to contact by research staff x 100
Measured: 3 to 6 months after baseline assessment
Secondary outcomes (3)
Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age
Dyad caregivers were asked what type of milk was being consumed by the infant, with 4 options available: 1) Formula only, 2) Mostly formula and some breast milk, 3) Mostly breast milk, but some formula, or 4) Breast milk only.
Measured: 3 to 6 months after baseline assessment
Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age
Dyads caregivers were asked, "Is your baby eating solid foods yet or do you put any solid foods in the bottle?", with 2 options available: 1) Yes or 2) No
Measured: 3 to 6 months after baseline assessment
Percent of Participants Reporting "Never" Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age
Dyad caregivers were asked "I watch TV or look at or use my phone while feeding my baby" and responded with one of 5 Likert-scale responses: 1) Never, 2) Seldom, 3) Half of the time, 4) Most of the time, 5) Always
Measured: 3 to 6 months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start7 May 2020
- Primary completion4 May 2021
- Study completion4 May 2021
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 ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Charles Wood, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216264
- Sponsor's protocol ID
- Pro00102738
- Other IDs
- U54MD012530
- Status last verified
- Oct 2022
- First submitted
- 30 Dec 2019
- Last updated
- 16 Nov 2022
- 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 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Adaptive Tool To Encourage Risk Reduction in iNfancy (PATTERN)
- ClinicalTrials.gov ID
- NCT04216264
- Acronym / sponsor ID
- Pro00102738
- Conditions
- Obesity
- Keywords
- infant, mother-baby
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 7 May 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Posted 16 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to learn about different approaches to promoting healthy growth among infants, and understanding parents' likes and dislikes of an approach to reducing risk factors for obesity later in life. The study includes filling out some forms with questions about your baby and your thoughts about your baby's growth and health, and engaging in a pattern of changes in or prevention of risk factors in the first year of life. Parents will receive information about changes and some tools and materials to take home with them. Some parents may receive phone calls between visits as well. The study takes place from soon after birth through the infant's age of 9 months. The estimated total time of interaction between the study staff and parents during the study period is 4 hours.
Detailed description
As this is a dyad study, each dyad is considered to be a participant and demographic information will reflect the infant in the dyad, per parent report.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Response | Other | Behavioral: Standard response |
| Non-response | Other | Behavioral: Targeted response |
Who may qualify
- Ages
- 2 weeks to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Non-Hispanic black (as documented in MaestroCare) parents/caregivers with; infants ages 2 weeks to 2 months of age; infant birthweight between 2500g and 4000g; infant gestational age is at least 36 weeks
Key exclusion criteria (1 listed)
- non-English-speaking; infant with serious disease or disorder affecting growth and nutrition
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 |
|---|---|---|
| Standard responseParents pick from a menu of behavior changes | Behavioural | Response |
| Targeted responseStepped up phone interaction with parents based on menu of behavior changes | Behavioural | Non-response |
Primary outcome
Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire
Time frame: 3 to 6 months after baseline assessment
Completed Likert scale with 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5=very satisfied
Percentage of Successful Contacts With Families Via Telephone and/or in Clinic
Time frame: 3 to 6 months after baseline assessment
Number of successful contacts with families divided by number of attempts to contact by research staff x 100
3 secondary outcomes
Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age
Time frame: 3 to 6 months after baseline assessment
Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age
Time frame: 3 to 6 months after baseline assessment
Percent of Participants Reporting "Never" Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age
Time frame: 3 to 6 months after baseline assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- 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.
Charles Wood principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard response and Targeted response in people with Obesity, run by Duke University 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 1 inclusion and 1 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 16 Nov 2022. 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 16 Nov 2022). 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?
Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire (time frame: 3 to 6 months after baseline assessment). The study lists 2 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 16 Nov 2022.