Eating BehaviorNCT06072664
Mother-Baby Study - Caloric Compensation Index (COMPX)
A study testing Caloric Compensation Index (COMPX) in people with Eating Behavior, run by University of Michigan at 1 site in United States.
Trial summary
The study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity. Read more about this study
- Who is it for?
- Ages 0 days and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Caloric Compensation Index (COMPX)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2023to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
The child is a participant in the observational study (NCT06039878).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fundamental Biobehavioral Mechanisms Underlying the Integrated Development of Emotion, Attachment, and Nutritive Intake in the Mother-Infant Dyad
The study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.
To participate in this study the infant must also be enrolled in long-term observational study, NCT06039878.
Read the detailed description
This interventional task is done with children while they are in the long-term observational study, NCT06039878, at approximately ages 18 and 36 months. In the observational study there are 300 participants (150 mothers and 150 children). In this trial only data from the children is collected and therefore only 150 participants are listed.
- Conditions
- Eating Behavior
- Being tested
- Caloric Compensation Index (COMPX)
- Keywords
- eating behavior
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric Compensation Index (COMPX)Behavioural
Researcher gives child opportunity to consume high- and low-calorie preloads and then free access to a palatable snack
| Study group | Role | What they receive |
|---|---|---|
| Caloric Compensation | Experimental | The researchers will enroll 150 children from the long-term observational study, NCT06039878. Receives: Behavioral: Caloric Compensation Index (COMPX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in energy intake of palatable snack following a high-calorie versus low-calorie preload
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start21 Dec 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Lumeng, University of Michigan
- Investigators
- Julie Lumeng, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072664
- Sponsor's protocol ID
- HUM00227836 CT3 (COMPX)
- Other IDs
- R01DK134979
- Status last verified
- Aug 2026
- First submitted
- 2 Oct 2023
- Last updated
- 9 Sep 2026
- Results posted
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fundamental Biobehavioral Mechanisms Underlying the Integrated Development of Emotion, Attachment, and Nutritive Intake in the Mother-Infant Dyad
- ClinicalTrials.gov ID
- NCT06072664
- Acronym / sponsor ID
- HUM00227836 CT3 (COMPX)
- Conditions
- Eating Behavior
- Keywords
- eating behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Oct 2023 (actual)
- 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 study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.
To participate in this study the infant must also be enrolled in long-term observational study, NCT06039878.
Detailed description
This interventional task is done with children while they are in the long-term observational study, NCT06039878, at approximately ages 18 and 36 months. In the observational study there are 300 participants (150 mothers and 150 children). In this trial only data from the children is collected and therefore only 150 participants are listed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caloric Compensation | Experimental | Behavioral: Caloric Compensation Index (COMPX)The researchers will enroll 150 children from the long-term observational study, NCT06039878. |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Caloric Compensation Index (COMPX)Researcher gives child opportunity to consume high- and low-calorie preloads and then free access to a palatable snack | Behavioural | Caloric Compensation |
Primary outcome
Difference in energy intake of palatable snack following a high-calorie versus low-calorie preload
Time frame: Up to approximately 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- 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.
Julie Lumeng, MD study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric Compensation Index (COMPX) in people with Eating Behavior, run by University of Michigan 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?
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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Difference in energy intake of palatable snack following a high-calorie versus low-calorie preload (time frame: Up to approximately 36 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 9 Sep 2026.