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| Name | Class |
|---|---|
| Health Resources and Services Administration (HRSA) | FED |
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The First Heroes study plans to influence weight and health trajectories, modify disease risk, and improve health care services for mother-father-infant triads from racial/ethnic minority and health disparity populations.
This study is a two-arm, randomized controlled trial recruiting from Massachusetts General Hospital (MGH) obstetrics practices. This study will enroll 250 father-mother dyads in the second trimester of pregnancy and intervene through their offspring's 1-year birthday. Each mother-father dyad participating will be randomly assigned to one of two arms: 1. Obstetric and Pediatric Standard of Care + New Parent Engagement Intervention Arm or; 2. Obstetric and Pediatric Standard of Care + Safety Control Arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Parent Intervention | Experimental |
| |
| Safety Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Parent Intervention | Behavioral | This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Infants With Rapid Infant Weight Gain | Defined as an increase in weight-for-age z-score of >0.67 units from birth to 6-months of infant age | Birth to child age 6 months |
| Number of Infants With Rapid Infant Weight Gain | Defined as an increase in weight-for-age z-score of >0.67 units from birth to 12-months of infant age | Birth to child age 12 months |
| Number of Overweight Infant Participants (WHO Criteria) | Weight-for-length ≥97.7th percentile based on World Health Organization (WHO) standards | Birth to child age 12 months |
| Number of Overweight Infant Participants (CDC Criteria) | Weight-for-length ≥95 percentile based on Center for Disease Control | Birth to child age 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Post-partum Weight Retention | Difference between 6-month postpartum weight and pre-pregnancy weight in kilograms. | Pre-pregnancy to 6-month postpartum |
| Maternal Post-partum Weight Retention |
| Measure | Description | Time Frame |
|---|---|---|
| Family Enrollment in Food Assistance Programs | Responding YES to the question: "Does your family currently receive benefits from WIC?" | 12 months |
| Family Housing Insecurity During Intervention Period | National Survey of American Families - 2-item validated scale, response of YES to either question was determined positive screen ((1) During the last 12 months, was there a time when you and your family were not able to pay your mortgage, rent or utility bills? (2) During the last 12 months, did you or your children move in with other people even for a little while because you could not afford to pay your mortgage, rent or utility bills?) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elsie Taveras, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35624421 | Background | Silver SR, Whooten RC, Kwete GM, Farrar-Muir H, Cournoyer RN, Barth EA, Kotelchuck M, Taveras EM. Stakeholder engagement in developing a father-inclusive early life obesity prevention intervention: First Heroes. BMC Pregnancy Childbirth. 2022 May 27;22(1):443. doi: 10.1186/s12884-022-04759-z. | |
| 33340750 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | New Parent Intervention - Mothers | New Parent Intervention - Mothers: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach. |
| FG001 | Safety Control - Mothers | Safety Control - Mothers: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials. |
| FG002 | New Parent Intervention - Fathers | New Parent Intervention - Fathers: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach |
| FG003 | Safety Control - Fathers | Safety Control- Fathers: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials. |
| FG004 | New Parent Intervention - Infants | New Parent Intervention - Infants: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach |
| FG005 | Safety Control - Infants | Safety Control - Infants: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Includes all members of mother, father, infant triad.
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| ID | Title | Description |
|---|---|---|
| BG000 | New Parent Intervention - Mothers | New Parent Intervention - Mothers: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Infants With Rapid Infant Weight Gain | Defined as an increase in weight-for-age z-score of >0.67 units from birth to 6-months of infant age | Based on those with complete growth data at birth and 6-months. | Posted | Count of Participants | Participants | Birth to child age 6 months |
|
Adverse event data was collected from baseline survey (2nd trimester of pregnancy) to final survey (infant age 12 months); approximately 15 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | New Parent Intervention-Mother | New Parent Intervention-Mother: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel Whooten | Massachusetts General Hospital | 6176434585 | rwhooten@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 4, 2023 | Jan 15, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2025 | Jan 15, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Safety Control | Behavioral | This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials. |
|
Difference between 12-month postpartum weight and pre-pregnancy weight in kilograms.
| Prepregnancy to 12-month postpartum |
| Maternal Diet | Average weekly intake of fruits and vegetables | 6-month postpartum |
| Maternal Diet | Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often. | 12-month postpartum |
| Maternal Physical Activity | Days per week physically active for at least 30 minutes per day | 6-month postpartum |
| Maternal Physical Activity | Self-report (Yes/No) of participation in any moderate-vigorous physical activity. Percentage below represents those endorsing YES to participating in moderate vigorous physical activity. | 12-month postpartum |
| Maternal Adherence to Preventive Health Services | Endorsing PCP visit in the past year. | 12 months post-partum |
| Paternal Mean Body Mass Index | Mean change in paternal BMI from baseline to 6 months postpartum, calculated by weight in kilograms and height in meters to report BMI in kg/m^2. | Baseline to 6-month postpartum |
| Paternal Mean Body Mass Index | Mean change in paternal obesity calculated by weight in kilograms and height in meters to report BMI in kg/m^2. | Baseline to 12-month postpartum |
| Paternal Prevalence of Obesity | Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters. | Baseline to 12-month postpartum |
| Paternal Adherence to Preventive Health Services | Endorsement of PCP visit in the past year. | 12-month post-partum |
| Paternal Diet | Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often. | 6 months post-partum |
| Paternal Diet | Average daily intake of fruits and vegetables | 12 months post-partum |
| Paternal Physical Activity | Days per week physically active for at least 30 minutes per day | 6 months post-partum |
| Paternal Physical Activity | Participation in moderate/vigorous physical activity (Responding YES) | 12 months post-partum |
| Parental Perceived Stress | Perceived Stress Scale - 4-item validated scale; Scores range from 0 to 16, with higher scores indicating higher perceived stress. | 6 month post-partum |
| Prevalence of Parental Post-partum Depression Risk | Patient Health Questionnaire 2 (PHQ-2), scored from 0 to 6 with higher scores indicating increased risk. For purposes of this measure, 'low depression risk' included score 0-2 and 'depression risk' included score 3-6. The percentage reported below represents those with "Increased depression risk (3-6)" | 6 month post-partum |
| Prevalence of Parental Post-partum Depression | Patient Health Questionnaire 2 (PHQ-2); PHQ-2 positive screen, Total score: 0-6; ≥ 3 → positive depression screen | 12 month post-partum |
| Prevalence of Breastfeeding Initiation | Self-reported response questionnaire - has infant ever been breastfed? | 6 months post-partum |
| Infant Introduction of Solid Foods | Age (months) at introduction of solid foods. | 6 months post-partum |
| Baseline |
| Family Food Insecurity During Intervention Period | Hager 2-question validated scale - responded YES to either of two questions relating to household food insecurity ((1) Within the past 12 months we worried whether our food would run out before we got money to buy more (2) Within the past 12 months the food we bought just didn't last and we didn't have money to get more) | Baseline |
| Whooten RC, Kwete GM, Farrar-Muir H, Cournoyer RN, Barth EA, Kotelchuck M, Taveras EM. Engaging fathers in the first 1000 days to improve perinatal outcomes and prevent obesity: Rationale and design of the First Heroes randomized trial. Contemp Clin Trials. 2021 Feb;101:106253. doi: 10.1016/j.cct.2020.106253. Epub 2020 Dec 17. |
| 37719794 | Background | Whooten RC, Kotelchuck M, Gonzalez AVC, Johnson N, Kwete G, Luo M, Muir HF, Barth EA, Smith N, Taveras EM. Expectant fathers' health behaviors, infant care intentions, and social-emotional wellbeing in the perinatal period: A latent class analysis and comparison to mothers. Prev Med Rep. 2023 Aug 26;36:102375. doi: 10.1016/j.pmedr.2023.102375. eCollection 2023 Dec. |
| Safety Control - Mothers |
Safety Control- Mothers: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials. |
| BG002 | New Parent Intervention - Fathers | New Parent Intervention - Fathers: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach. |
| BG003 | Safety Control - Fathers | Safety Control- Fathers: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials. |
| BG004 | New Parent Intervention - Infants | New Parent Intervention - Infants: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach. |
| BG005 | Safety Control - Infants | Safety Control- Infants: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Infants With Rapid Infant Weight Gain | Defined as an increase in weight-for-age z-score of >0.67 units from birth to 12-months of infant age | Posted | Count of Participants | Participants | Birth to child age 12 months |
|
|
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| Primary | Number of Overweight Infant Participants (WHO Criteria) | Weight-for-length ≥97.7th percentile based on World Health Organization (WHO) standards | Posted | Count of Participants | Participants | Birth to child age 12 months |
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| Primary | Number of Overweight Infant Participants (CDC Criteria) | Weight-for-length ≥95 percentile based on Center for Disease Control | Posted | Count of Participants | Participants | Birth to child age 12 months |
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| Secondary | Maternal Post-partum Weight Retention | Difference between 6-month postpartum weight and pre-pregnancy weight in kilograms. | Posted | Mean | Standard Deviation | kg | Pre-pregnancy to 6-month postpartum |
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| Secondary | Maternal Post-partum Weight Retention | Difference between 12-month postpartum weight and pre-pregnancy weight in kilograms. | Posted | Mean | Standard Deviation | kg | Prepregnancy to 12-month postpartum |
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| Secondary | Maternal Diet | Average weekly intake of fruits and vegetables | Posted | Mean | Standard Deviation | servings/day | 6-month postpartum |
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| Secondary | Maternal Diet | Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often. | Posted | Count of Participants | Participants | 12-month postpartum |
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| Secondary | Maternal Physical Activity | Days per week physically active for at least 30 minutes per day | Posted | Mean | Standard Deviation | days/week | 6-month postpartum |
|
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| Secondary | Maternal Physical Activity | Self-report (Yes/No) of participation in any moderate-vigorous physical activity. Percentage below represents those endorsing YES to participating in moderate vigorous physical activity. | Posted | Count of Participants | Participants | 12-month postpartum |
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| Secondary | Maternal Adherence to Preventive Health Services | Endorsing PCP visit in the past year. | Posted | Count of Participants | Participants | 12 months post-partum |
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| Secondary | Paternal Mean Body Mass Index | Mean change in paternal BMI from baseline to 6 months postpartum, calculated by weight in kilograms and height in meters to report BMI in kg/m^2. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline to 6-month postpartum |
|
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| Secondary | Paternal Mean Body Mass Index | Mean change in paternal obesity calculated by weight in kilograms and height in meters to report BMI in kg/m^2. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline to 12-month postpartum |
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| Secondary | Paternal Prevalence of Obesity | Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters. | Posted | Count of Participants | Participants | Baseline to 12-month postpartum |
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| Secondary | Paternal Adherence to Preventive Health Services | Endorsement of PCP visit in the past year. | Posted | Count of Participants | Participants | 12-month post-partum |
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| Secondary | Paternal Diet | Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often. | Posted | Count of Participants | Participants | 6 months post-partum |
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| Secondary | Paternal Diet | Average daily intake of fruits and vegetables | Posted | Mean | Standard Deviation | servings/days | 12 months post-partum |
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| Secondary | Paternal Physical Activity | Days per week physically active for at least 30 minutes per day | Posted | Mean | Standard Deviation | days/week | 6 months post-partum |
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| Secondary | Paternal Physical Activity | Participation in moderate/vigorous physical activity (Responding YES) | Posted | Count of Participants | Participants | 12 months post-partum |
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| Secondary | Parental Perceived Stress | Perceived Stress Scale - 4-item validated scale; Scores range from 0 to 16, with higher scores indicating higher perceived stress. | Posted | Mean | Standard Deviation | score on a scale | 6 month post-partum |
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|
|
| Secondary | Prevalence of Parental Post-partum Depression Risk | Patient Health Questionnaire 2 (PHQ-2), scored from 0 to 6 with higher scores indicating increased risk. For purposes of this measure, 'low depression risk' included score 0-2 and 'depression risk' included score 3-6. The percentage reported below represents those with "Increased depression risk (3-6)" | Posted | Count of Participants | Participants | 6 month post-partum |
|
|
|
| Secondary | Prevalence of Parental Post-partum Depression | Patient Health Questionnaire 2 (PHQ-2); PHQ-2 positive screen, Total score: 0-6; ≥ 3 → positive depression screen | Posted | Count of Participants | Participants | 12 month post-partum |
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| Secondary | Prevalence of Breastfeeding Initiation | Self-reported response questionnaire - has infant ever been breastfed? | Posted | Count of Participants | Participants | 6 months post-partum |
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| Secondary | Infant Introduction of Solid Foods | Age (months) at introduction of solid foods. | Posted | Mean | Standard Deviation | age (months) | 6 months post-partum |
|
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| Other Pre-specified | Family Enrollment in Food Assistance Programs | Responding YES to the question: "Does your family currently receive benefits from WIC?" | Posted | Count of Participants | Participants | 12 months |
|
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| Other Pre-specified | Family Housing Insecurity During Intervention Period | National Survey of American Families - 2-item validated scale, response of YES to either question was determined positive screen ((1) During the last 12 months, was there a time when you and your family were not able to pay your mortgage, rent or utility bills? (2) During the last 12 months, did you or your children move in with other people even for a little while because you could not afford to pay your mortgage, rent or utility bills?) | Posted | Count of Participants | Participants | Baseline |
|
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| Other Pre-specified | Family Food Insecurity During Intervention Period | Hager 2-question validated scale - responded YES to either of two questions relating to household food insecurity ((1) Within the past 12 months we worried whether our food would run out before we got money to buy more (2) Within the past 12 months the food we bought just didn't last and we didn't have money to get more) | Measured at baseline only; not follow-up. | Posted | Count of Participants | Participants | Baseline |
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| 0 |
| 113 |
| 0 |
| 113 |
| 0 |
| 113 |
| EG001 | Safety Control-Mother | Safety Control-Mother: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials. | 0 | 114 | 0 | 114 | 0 | 114 |
| EG002 | New Parent Intervention-Father | New Parent Intervention-Father: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach. | 0 | 113 | 0 | 113 | 0 | 113 |
| EG003 | Safety Control-Father | Safety Control-Father:This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials. | 0 | 114 | 0 | 114 | 0 | 114 |
| EG004 | New Parent Intervention-Infant | New Parent Intervention-Infant: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach. | 0 | 93 | 0 | 93 | 0 | 93 |
| EG005 | Safety Control - Infant | Safety Control - Infant: This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials. | 0 | 101 | 0 | 101 | 0 | 101 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001522 | Behavior, Animal |