Fundamental Biobehavioral Mechanisms Underlying the Integrated Development of Emotion, Attachment, and Nutritive Intake in the Mother-Infant Dyad
概览
- 阶段
- 不适用
- 干预措施
- Bonding-Evoked Oxytocin
- 疾病 / 适应症
- Obesity, Childhood
- 发起方
- University of Michigan
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Weight-for-length z-score
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
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.
详细描述
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.
研究者
Julie Lumeng
Associate Vice President for Research-Clinical and Human Subjects Research, Office of Research, Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics, Associate Dean for Research, Medical School
University of Michigan
入排标准
入选标准
- •To be eligible to participate in this study, they mother-child dyad must meet all of the following criteria:
- •Provision of signed and dated informed consent form by mother for herself and infant
- •Stated willingness by mother to comply with all study procedures and availability for the duration of the study
- •Infant gestational age 37.0 - 42.0 weeks based on maternal report of due date and child's birth date
- •Infant birth weight by maternal report appropriate (≥ 3rd percentile and ≤ 97th percentile) for gestational age and sex based on US Natality Data set.
- •Mother is biological mother both genetically and gestationally by maternal report (i.e., conception with her own (versus donor) egg and she was pregnant (versus a surrogate)
- •Biological mother is legal guardian by maternal report
- •Biological mother is full time custodial guardian by maternal report (versus sharing custody such that infant does not live with her full time)
- •Infant has fed at least 2.0 ounces in one feeding from an artificial nipple and bottle by maternal report or mother reports planning to do prior to first task requiring artificial nipple and bottle during age 1.0 month data collection window
- •Any dyad who meets any of the following criteria will be excluded from participation in this study:
排除标准
- 未提供
研究组 & 干预措施
Mother-Infant Dyad
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 ).
干预措施: Bonding-Evoked Oxytocin
Mother-Infant Dyad
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 ).
干预措施: Distress Relieving Effects of Sucrose
Mother-Infant Dyad
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 ).
干预措施: Hedonic Response to Sucrose
Mother-Infant Dyad
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 ).
干预措施: Typical versus Challenging Feeding-Social
Mother-Infant Dyad
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 ).
干预措施: Caloric Compensation-Social
Mother-Infant Dyad
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 ).
干预措施: Ability to Delay Gratification for Food in Infants-Social Task (ATDG-FIT-Social)
结局指标
主要结局
Weight-for-length z-score
时间窗: Up to 36 months (infant age)
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