ObesityNCT02766218
Mealtime Interactions and Risk of Toddler Obesity
An observational study of Obesity, run by Temple University.
Trial summary
The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with mother-toddler dyads who participated in a study that is testing the effects of a multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain in obese women. Read more about this study
- Who is it for?
- Ages 18 to 36 months
- Conditions the study is for
- Obesity
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jun 2019
- Phase
- Observational
- 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 to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: Mothers and their 18-month-old toddlers who participated in clinical trial #NCT01545934 will be invited to participate in this observational study.
Who may be able to join
- Mother participated in clinical trial #NCT01545934
- Child 18-36 months old
Who cannot join
- Child chronic health conditions that could affect feeding or growth (diagnosed feeding disorders, use of feeding tube) or could influence the mealtime interaction (significant food allergies or dietary restrictions, diagnosed psychiatric disorders, or pervasive developmental delays).
About this study
Official title: Mealtime Interactions and Risk of Obesity in Toddlers
The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with mother-toddler dyads who participated in a study that is testing the effects of a multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain in obese women. Specifically, dyads will be invited to participate in home-based assessments to videotape an evening meal, have anthropometric measures taken, and complete study questionnaires. The overall goal is to understand factors related prospectively to responsive feeding between mothers and toddlers at 18 months; determine whether responsive feeding at 18 and 24 months predicts change in zBMI and adiposity from 18-36 months; and explore which factors are most strongly predictive of child zBMI change from birth to 36 months.
- Conditions
- Obesity
- Keywords
- toddler obesity, responsive feeding, behavioral weight control, pregnancy weight gain, early life risk factors
- Medical subject headings
- Obesity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: Lifestyle Intervention | The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy. | |
| No Intervention: Standard Care | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responsive feeding
The Responsiveness to Child Feeding Cues Scale will be used to code maternal responsive feeding. Primary outcomes are: a) maternal responsiveness to toddler fullness cues.
Measured: 18- and 24-months
Secondary outcomes (1)
Child Weight Status
zBMI will be computed at each time point
Measured: birth, 6-, 12-, 18-, 24- and 36-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- The Miriam Hospital, California Polytechnic State University-San Luis Obispo, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Chantelle Hart, PhD, Principal investigator, Temple UniversitySuzanne Phelan, PhD, Principal investigator, California Polytechnic State University-San Luis ObispoRena Wing, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766218
- Sponsor's protocol ID
- 23356
- Other IDs
- R01DK108661, R56DK108661
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2016
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mealtime Interactions and Risk of Obesity in Toddlers
- ClinicalTrials.gov ID
- NCT02766218
- Acronym / sponsor ID
- 23356
- Conditions
- Obesity
- Keywords
- toddler obesity, responsive feeding, behavioral weight control, pregnancy weight gain, early life risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- The Miriam Hospital, California Polytechnic State University-San Luis Obispo, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 9 May 2016 (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.
The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with mother-toddler dyads who participated in a study that is testing the effects of a multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain in obese women. Specifically, dyads will be invited to participate in home-based assessments to videotape an evening meal, have anthropometric measures taken, and complete study questionnaires. The overall goal is to understand factors related prospectively to responsive feeding between mothers and toddlers at 18 months; determine whether responsive feeding at 18 and 24 months predicts change in zBMI and adiposity from 18-36 months; and explore which factors are most strongly predictive of child zBMI change from birth to 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Lifestyle Intervention | – | –The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy. |
| No Intervention: Standard Care | – | – |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Mothers and their 18-month-old toddlers who participated in clinical trial #NCT01545934 will be invited to participate in this observational study.
Key inclusion criteria (2 listed)
- Mother participated in clinical trial #NCT01545934
- Child 18-36 months old
Key exclusion criteria (1 listed)
- Child chronic health conditions that could affect feeding or growth (diagnosed feeding disorders, use of feeding tube) or could influence the mealtime interaction (significant food allergies or dietary restrictions, diagnosed psychiatric disorders, or pervasive developmental delays).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Responsive feeding
Time frame: 18- and 24-months
The Responsiveness to Child Feeding Cues Scale will be used to code maternal responsive feeding. Primary outcomes are: a) maternal responsiveness to toddler fullness cues.
1 secondary outcome
Child Weight Status
Time frame: birth, 6-, 12-, 18-, 24- and 36-months
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 4 Feb 2021.
- 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.
Chantelle Hart, PhD principal investigator
Temple University
Suzanne Phelan, PhD principal investigator
California Polytechnic State University-San Luis Obispo
Rena Wing, PhD principal investigator
The Miriam Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Temple University.
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 2 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 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Responsive feeding (time frame: 18- and 24-months). 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 4 Feb 2021.