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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK134979 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The rate of weight gain in the first year of life is risk factor for future obesity. The study will test (1) a model of l mechanisms underlying the development of emotion, attachment, and nutritive intake; and (2) the association with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.
This multi-year study was originally accurately registered as an observational study. The outcome measures are not measuring dependent variables based on the interventions; rather the interventions are experiments to categorize infant responses for the purpose of grouping infants according to their behaviors. There are small trials associated with the grant at National Clinical Trial numbers (NCT #s): NCT06072664, NCT06072651, and NCT06072638 to analyze behaviors at 18 and 36 months of age. However, because the NIH grant covering this study needs to be linked to a trial for computer smart logic purposes, and this overarching study connects with the most complete enrollment numbers, the record was modified in 2024 to show it as a trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mother-Infant Dyad | Experimental | The researchers will enroll 150 infants and their mothers (150 dyads, 300 total participants). The researchers anticipate, based on prior experience and the slightly more restrictive inclusion and exclusion criteria in this study compared to our prior work, needing to screen about 600 mother-infant dyads to achieve the target sample size of 150. The researchers anticipate that the sample will be 63% non-Hispanic white, 13% non-Hispanic black, 4% non-Hispanic Asian, 12% non-Hispanic multiracial, and 8% Hispanic (any race). The researchers expect that 50% of the infants will be male and 50% female, and all of the biological mothers will be female sex. Infants will be 0.5-1.5 months at enrollment and the researchers estimate that mothers will be between 18.0 and 50.0 at enrollment (upper age limit is estimated due to menopause ). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bonding-Evoked Oxytocin | Behavioral | Mother participates in bonding activity with infant at ages 1, 3, and 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight-for-length z-score | Infants will be weighed and length will be measured recumbent using an infantometer. Weight-for-length will be calculated and z-scored against World Health Organization growth charts | Up to 36 months (infant age) |
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To be eligible to participate in this study, they mother-child dyad must meet all of the following criteria:
Any dyad who meets any of the following criteria will be excluded from participation in this study:
All participants must be enrolled in all parts of the Mother-Baby study (1 Observational study and 4 Clinical Trials)
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| Name | Affiliation | Role |
|---|---|---|
| Julie Lumeng, MD | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| Distress Relieving Effects of Sucrose | Behavioral | Researcher elicits distress in the infant (sequence of unswaddling, pacifier removal, and arm restraint), followed by delivery of oral sucrose in one condition and water in other condition |
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| Hedonic Response to Sucrose | Behavioral | Researcher gives infant opportunity to suck from two bottles, one containing sucrose and one plain water at infant ages 1, 3, and 6 months |
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| Typical versus Challenging Feeding-Social | Behavioral | Mother feeds infant on four counterbalanced days at infant ages 1, 3, and 6 months crossing two conditions: (1) regular size nipple versus smaller aperture nipple ('challenging') and (2) providing social interaction while feeding versus not. |
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| Caloric Compensation-Social | Behavioral | Mother feeds infant on four counterbalanced days at infant ages 1, 3, and 6 months crossing two conditions: (1) offering a bottle feeding ad lib for 3 hours versus offering a bottle feeding every hour for 3 hours; (2) providing social interaction while feeding versus not. |
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| Ability to Delay Gratification for Food in Infants-Social Task (ATDG-FIT-Social) | Behavioral | When mother indicates infant is hungry, she presents the infant the bottle but withholds feeding for 5 minutes, feeds for one minute, withholds feeding for 30 seconds, and then resumes feeding. She does so under two conditions (providing social interaction during feeding versus not) on two counterbalanced days at infant ages 1, 3, and 6 months. |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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