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| ID | Type | Description | Link |
|---|---|---|---|
| H-28013 | Other Identifier | Baylor College of Medicine |
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| Name | Class |
|---|---|
| Washington State University | OTHER |
| University of Colorado, Denver | OTHER |
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The goal of this study is to develop and test the efficacy of a scientifically-based, culturally competent seven-session parent directed, obesity prevention program focused on parental feeding strategies that support young children's self-regulation of intake.
The intervention program was developed and piloted. Expected outcomes: At the end of the intervention program, it is expected that parents in the intervention group will: 1) use more child-centered (e.g., repeated presentation of new foods, involvement in food preparation) and less parent-centered feeding directives; 2) be less likely to show an indulgent and more likely to show an authoritative feeding style (feeding responsiveness); 3) show lower scores on restriction and pressure to eat and higher scores on monitoring; and 4) demonstrate higher levels of food knowledge (e.g., best feeding practices, reduced feeding misconceptions). Children in the intervention group are expected to: 1) show more willingness to try new foods, and 2) show increased self-regulation of energy intake. At the end of the interventions, children are expected to show greater consumption of fruits and vegetables (including consuming a wider variety of fruits and vegetables). All effects are expected to continue through the 6- and 12-month follow-ups, although the effects sizes will diminish. Although we do not expect effects on BMI after 6 weeks, we expect to see decreases in children's BMI percentiles by the 6- and 12-month follow-ups for the intervention group-especially for the top 25% of the BMI percentile range. No parental BMI effects are expected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent and child classes (prevention group) | Experimental | Parent and child groups focused on self-regulation of eating |
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| Treatment as usual (control group) | No Intervention | Treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent and child groups focused on self-regulation of eating | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Children's BMI Percentiles | Measured child height and weight data were collected. Two height and weight measures were averaged for each child. Age- and gender-specific BMI z-scores for each child were calculated. Children were classified into healthy weight (5th to <85th percentile), overweight (≥85th to <95th percentile), and obese (≥95th percentile) according to Centers for Disease Control and Prevention standards. | 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Feeding Behaviors | Questionnaire data (parent-report). Subscale scores from the Food Parenting Inventory and Feeding Knowledge Questionnaire were used to measure secondary outcomes. All scales included response categories ranging from 1 to 5. Higher scores were considered better on the following subscales: repeated presentation of new foods; measured child portion sizes; child involvement in food preparation; feeding responsiveness; knowledge of best feeding practices; feeding efficacy. Lower scores were considered better on the subscale of feeding misconceptions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheryl O Hughes, PhD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States | ||
| Thomas G. Power |
No significant events occurred in this study after participant enrollment.
Parent/child dyads were recruited in 2014-2016 from Head Start centers in Houston, TX, and child care centers serving families with low incomes in Pasco, WA. The Pasco centers were similar to Head Start in that they provided free services and support for families with low incomes. The goal of these centers was to ensure that all children enter kindergarten ready to succeed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Parent and Child Classes (Prevention Group) | Parent and child groups focused on self-regulation of eating |
| FG001 | Treatment as Usual (Control Group) | Treatment as usual, parents and children did not receive any treatment as the control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Group Allocation |
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| Post Data Collection |
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| 6-month Follow-up |
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| 12-month Follow-up |
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A total of 255 parent/child dyads participated in the study (255 parents and their children). We report age, gender, and ethnicity for children and parents separately, thus there are 2 entries each for age, gender, and ethnicity (one for children and one for parents).
All analyses were intention-to-treat analyses. Specifically, data from parents and children were analyzed on the basis of the condition to which they were initially assigned, regardless of the number of classes they attended.
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| ID | Title | Description |
|---|---|---|
| BG000 | Parent and Child Classes (Prevention Group) | Parent and child groups focused on self-regulation of eating |
| BG001 | Treatment as Usual (Control Group) | Treatment as usual, parents and children did not receive any treatment as the control group. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Child age in months | Data on child age are missing for 1 child in the prevention group and 2 children in the control group. |
| 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 | Children's BMI Percentiles | Measured child height and weight data were collected. Two height and weight measures were averaged for each child. Age- and gender-specific BMI z-scores for each child were calculated. Children were classified into healthy weight (5th to <85th percentile), overweight (≥85th to <95th percentile), and obese (≥95th percentile) according to Centers for Disease Control and Prevention standards. | Prevention group: 76 children assessed at 12-months. Treatment as usual control group: 71 children assessed at 12-months. | Posted | Count of Participants | Participants | 12-month follow-up |
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Adverse events were monitored between August 2014 and December 2017.
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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 | Prevention Group | Group focused on self-regulation of eating | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sheryl O. Hughes, Associate Professor | Baylor College of Medicine | 713-798-7017 | shughes@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2022 | Mar 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 12-month follow-up |
| Pullman |
| Washington |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| months |
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| Age, Continuous | Parent age in years | Data on parent age are missing for 4 parents in the prevention group and 3 parents in the control group. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Parent-report of child sex | Count of Participants | Participants |
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| Sex: Female, Male | Parent self-report of sex | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Parent-report of child ethnicity | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Parent self-report of ethnicity | Count of Participants | Participants |
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| Region of Enrollment | Data were collected from both parents and their children and data are reported as family unit, i.e., parent/child dyads. Data were collected from dyads in Houston, TX and Pasco, WA. | Number | Parent/child dyad |
|
| Children's BMI Percentiles | Measured child height and weight data were collected. Two height and weight measures were averaged for each child. Age- and gender-specific BMI z-scores for each child were calculated. Children were classified into healthy weight (5th to <85th percentile), overweight (≥85th to <95th percentile), and obese (≥95th percentile) according to Centers for Disease Control and Prevention standards. | Child height and weight data were not available for 2 participants in the "parent and child classes" group and 2 participants in the "treatment as usual" group. | Count of Participants | Participants |
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Treatment as usual control group did not receive any treatment |
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| Secondary | Parental Feeding Behaviors | Questionnaire data (parent-report). Subscale scores from the Food Parenting Inventory and Feeding Knowledge Questionnaire were used to measure secondary outcomes. All scales included response categories ranging from 1 to 5. Higher scores were considered better on the following subscales: repeated presentation of new foods; measured child portion sizes; child involvement in food preparation; feeding responsiveness; knowledge of best feeding practices; feeding efficacy. Lower scores were considered better on the subscale of feeding misconceptions. | Prevention group: 67 parents assessed at 12-months. Treatment as usual control group: 54 parents assessed at 12-months. | Posted | Mean | 95% Confidence Interval | score on a scale | 12-month follow-up |
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| 136 |
| 0 |
| 136 |
| 0 |
| 136 |
| EG001 | Treatment as Usual Control Group | Treatment as usual control group did not receive any treatment | 0 | 119 | 0 | 119 | 0 | 119 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
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| Unknown or Not Reported |
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| Obese (≥95th percentile) |
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| measured child portion sizes |
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| child involvement in food preparation |
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| feeding responsiveness |
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| knowledge of best feeding practices |
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| feeding misconceptions |
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| feeding efficacy |
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