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Mothers' Thoughts About Kids and Eating

Primary Purpose

Overweight

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Reading Information

About this trial

This is an interventional basic science trial for Overweight focused on measuring Risk Perception, Obesity Risk, Healthy Volunteer, HV

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA :

Study 1:

All participants will be healthy adult women over the age of 18 (though in practice the age range is likely to be constrained naturally by the required age of the index child).

having a self-reported body mass index of greater than or equal to 25
having some amount of familiarity with their family health history
having a biological child between the ages of 4 and 5 inclusive, who lives in the same household at least 1 day out of the past 30 days, and who has no major food allergies or diet-related health conditions, developmental delays, or disabilities
having the ability to read and write in English
being able to come to the NIH Clinical Center for one visit

EXCLUSION CRITERIA:

having a vestibular or seizure disorder;
having a high propensity for motion sickness;
known pregnancy; (4) uncorrected low vision or hearing;

(5) inability to complete tasks in the virtual environment;

(6) past or current history of eating disorder;

(7) NHGRI employees

Study 2:

INCLUSION CRITERIA:

All participants will be healthy adults over the age of 18 (though in practice the age range is likely to be constrained naturally by the required age of the index child).

having a self-perception of being overweight
having a biological child between the ages of 3 and 7
inclusive (of any weight), who has no food allergies to buffet items (e.g., dairy, wheat, fruit) or diet-related health conditions, developmental delays, or disabilities that would severely limit food
choices on the virtual buffet and who does not have a vegan or gluten-free diet
self-reporting that the parent is responsible for feeding to the child to criterion
having the ability to read and write in English
being able to come to the NIH Clinical Center for one visit

EXCLUSION CRITERIA:

having a vestibular or seizure disorder
having a high propensity for motion sickness
known pregnancy
uncorrected low vision or hearing
inability to complete tasks in the virtual environment
past or current history of eating disorder
NHGRI employees
having another household member or another biological parent of their index child having participated in the study
women who report being pregnant

Sites / Locations

National Institutes of Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Control

Family Environment Information

Gene times Family Environment Information

Genetic Information

Arm Description

Information about child health

Information about family environment factors in children's obesity risk

Information about interactions between genetic and family environment factors in children's obesity risk

Information about genetic factors in child obesity risk

Outcomes

Primary Outcome Measures

The number of calories selected for participant's index child in a virtual buffet food selection task

Secondary Outcome Measures

Full Information

NCT ID

NCT01087346

First Posted

March 13, 2010

Last Updated

October 19, 2023

Sponsor

National Human Genome Research Institute (NHGRI)

1. Study Identification

Unique Protocol Identification Number

NCT01087346

Brief Title

Mothers' Thoughts About Kids and Eating

Official Title

Mothers' Thoughts About What Their Children Eat

Study Type

Interventional

2. Study Status

Record Verification Date

June 1, 2023

Overall Recruitment Status

Completed

Study Start Date

November 19, 2010 (Actual)

Primary Completion Date

July 12, 2019 (Actual)

Study Completion Date

July 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Human Genome Research Institute (NHGRI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Summary: A few studies have explored the effects of providing parents with health information about their children. However, more information is needed about the relationship between awareness of health information and changes in behavior. This study will investigate the impact of health information on choices that parents make about food for their children. Mothers and fathers with a biological child between the ages of 3-7 years old may be eligible for this study. Participants are recruited from the Washington, DC metropolitan area. In this study, before visiting the research center, participants will answer online questionnaires about their children's health and eating habits and their own health and eating habits. At the research center, participants will use a virtual reality model of a buffet to make food choices for their children. Participants will be introduced to the computer-based virtual buffet scenario as a training session to prepare for using the buffet during the experimental context. While in the virtual environment, participants wear a virtual reality helmet that allows them to see the virtual buffet scenario. After the training session, participants will watch an interactive computer presentation about a health topic. Participants will then visit the virtual buffet scenario again for the formal session, and will choose a virtual lunch meal for their child as before. At the end of their visit, participants will complete post-test questionnaires about their experiences during the experiment and other research-related information. Participants will be asked to complete a follow-up questionnaire online a week after their visit The total time for the study visit is approximately 90 minutes. The participants children will not be asked to take part in the study. Eligibility: - Men and Women at least 18 years of age who have a biological child between the ages of 3 and 7 who has no major diet-related health conditions, developmental delays, or disabilities. You may not take part in the study if you have a history of seizures and/or are pregnant.

Detailed Description

Purpose This study will investigate the impact of health information on choices that parents make about food for their children. Participants will use a virtual reality model of a buffet to make food choices. Mothers and fathers with a biological child between the ages of 3-7 years old may be eligible for this study. Participants are recruited from the Washington, DC metropolitan area. Study participants will complete THREE sets of surveys and one task. Participants will complete a web-based survey before coming in for a study appointment. When participants arrive for their appointment, they will watch an interactive presentation on health information. Next, participants will interact in a virtual reality environment and will be asked to select virtual lunch for their child from a buffet. While in the virtual environment, a participant wears a head-mounted virtual reality headset that allows him/her to see elements of the environment. Participants will complete an additional computer-based survey. Finally, participants will be asked to complete an online questionnaire a week following their visit. The total time for the study visit is approximately 90 minutes. The participants children will not be asked to take part in the study. Detailed Description This study will investigate issues around the impact of health information on choices that parents make about food for their children. Participants will perform tasks that include completing computer-based surveys, watching an interactive computer-based presentation about health information, participating in a virtual reality model by selecting virtual lunch for their children from a buffet, and completing a computed-based exit survey. As part of the study, participants will wear a virtual reality helmet and be immersed in a buffet where they will select virtual lunch for their child. For this study, we are only recruiting men and women that have a biological child between the ages of 3-7 years old. You may not take part in the study if you have a history of seizures and/or are pregnant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight

Keywords

Risk Perception, Obesity Risk, Healthy Volunteer, HV

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

1148 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Information about child health

Arm Title

Family Environment Information

Arm Type

Experimental

Arm Description

Information about family environment factors in children's obesity risk

Arm Title

Gene times Family Environment Information

Arm Type

Experimental

Arm Description

Information about interactions between genetic and family environment factors in children's obesity risk

Arm Title

Genetic Information

Arm Type

Experimental

Arm Description

Information about genetic factors in child obesity risk

Intervention Type

Behavioral

Intervention Name(s)

Reading Information

Intervention Description

Reading information about risk factors for obesity among children

Primary Outcome Measure Information:

Title

The number of calories selected for participant's index child in a virtual buffet food selection task

Description

The number of calories selected for participant's index child in a virtual buffet food selection task

Time Frame

1 visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA : Study 1: All participants will be healthy adult women over the age of 18 (though in practice the age range is likely to be constrained naturally by the required age of the index child). having a self-reported body mass index of greater than or equal to 25 having some amount of familiarity with their family health history having a biological child between the ages of 4 and 5 inclusive, who lives in the same household at least 1 day out of the past 30 days, and who has no major food allergies or diet-related health conditions, developmental delays, or disabilities having the ability to read and write in English being able to come to the NIH Clinical Center for one visit EXCLUSION CRITERIA: having a vestibular or seizure disorder; having a high propensity for motion sickness; known pregnancy; (4) uncorrected low vision or hearing; (5) inability to complete tasks in the virtual environment; (6) past or current history of eating disorder; (7) NHGRI employees Study 2: INCLUSION CRITERIA: All participants will be healthy adults over the age of 18 (though in practice the age range is likely to be constrained naturally by the required age of the index child). having a self-perception of being overweight having a biological child between the ages of 3 and 7 inclusive (of any weight), who has no food allergies to buffet items (e.g., dairy, wheat, fruit) or diet-related health conditions, developmental delays, or disabilities that would severely limit food choices on the virtual buffet and who does not have a vegan or gluten-free diet self-reporting that the parent is responsible for feeding to the child to criterion having the ability to read and write in English being able to come to the NIH Clinical Center for one visit EXCLUSION CRITERIA: having a vestibular or seizure disorder having a high propensity for motion sickness known pregnancy uncorrected low vision or hearing inability to complete tasks in the virtual environment past or current history of eating disorder NHGRI employees having another household member or another biological parent of their index child having participated in the study women who report being pregnant

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan Persky, Ph.D.

Organizational Affiliation

National Human Genome Research Institute (NHGRI)

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29410480

Citation

Bouhlal S, Abrams LR, McBride CM, Persky S. Cognitive and affective factors linking mothers' perceived weight history to child feeding. Eur J Clin Nutr. 2018 Nov;72(11):1583-1591. doi: 10.1038/s41430-017-0071-0. Epub 2018 Feb 6.

Results Reference

derived

PubMed Identifier

25300916

Citation

Bouhlal S, McBride CM, Ward DS, Persky S. Drivers of overweight mothers' food choice behaviors depend on child gender. Appetite. 2015 Jan;84:154-60. doi: 10.1016/j.appet.2014.09.024. Epub 2014 Oct 6.

Results Reference

derived

Links:

URL

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2010-HG-0076.html

Description

NIH Clinical Center Detailed Web Page

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Mothers' Thoughts About Kids and Eating

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