- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05964218
Food-Body-Mind Intervention
Food-Body-Mind Intervention: Promote Whole Child Health
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Jiying Ling, PhD
- Phone Number: 5173538591
- Email: lingjiyi@msu.edu
Study Locations
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Michigan
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Jackson, Michigan, United States, 49203
- Recruiting
- Community Action Agency
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Contact:
- Codi Benjamin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parental consent and child (if the child is 5 years) verbal assent received
- Participants understand and speak English
- Children are 3-5 years old attending a Head Start program and caregivers are the primary adult caregivers for the children
- Caregivers are willing to use Facebook or the private program website for participation
- Participants have at least weekly internet access using a smartphone, a tablet, or a computer
Exclusion Criteria:
- preschoolers who have a motor disability or impairment (e.g., cerebral palsy, spinal cord injury, lost or damaged limb, motor skills disorder, muscular dystrophy, spina bifida) preventing them from participating in any physical activity;
- preschoolers who have a diagnosed medical condition (e.g., phenylketonuria, pediatric malabsorption syndrome, pollen food allergy syndrome) requiring a restrict diet and precluding them from any dietary changes particularly fruit/vegetable intake; and
- preschoolers who have diagnosed disorders (e.g., autism spectrum disorder) causing difficulty with communication and interaction with other people. Investigators expect these three criteria will exclude very few preschoolers based on investigators' prior clinical trial experiences working with Head Start daycare centers.
There will be no exclusion criterion for primary adult caregivers, as the primary focus is preschoolers and caregivers serve as a support role.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Food-Body-Mind Intervention
Guided by the Actor-Partner Interdependence Model, the Allostatic Load Model, and the Transactional Theory of Stress and Coping, the proposed 16-week Food-Body-Mind intervention includes: 1) a school-based mindfulness component delivered to equip preschoolers with knowledge and skills in mindful eating and movement (e.g., yoga, deep breathing exercises); 2) a home-based mindfulness component to increase caregivers' skills in practicing mindful eating, movement, and parenting behaviors at home to foster a more positive, mindful, and healthy home environment; and 3) a school learning and home practice connection component to improve caregiver-preschooler relationships.
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The Food-Body-Mind intervention includes 3 main components: 1) a school-based mindfulness component delivered by daycare teachers to equip preschoolers with knowledge and skills in mindful eating and movement (e.g., yoga, deep breathing exercises) to reduce emotional eating and increase F/V intake and physical activity; 2) a home-based mindfulness component to increase caregivers' skills in practicing mindful eating, movement, and parenting behaviors at home to foster a more positive, mindful, and healthy home environment; and 3) a preschooler school learning and caregiver home practice connection component to improve caregiver-preschooler relationships.
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No Intervention: Usual Care Control
Like those in the intervention group, preschoolers assigned to the control group will receive usual Head Start activities during the intervention period.
After the 12-month follow-up data collection from both intervention and control participants in each year, each control family will receive all intervention supplies including the "Tasty Healthy Cookbook," "MyPlate" plates, and a breathing ball, as well as the program manual on how to use the intervention supplies.
These intervention supplies will be distributed to control families at the end of in-person data collection appointments.
Moreover, a virtual caregiver meeting on mindful eating, movement, and parenting will be provided to all caregivers who are interested.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preschoolers' problem behaviors
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2)
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Problem behaviors will be assessed by the Preschool and Kindergarten Behavior Scales-Second Edition (PKBS-2).
The Problem Behavior scale includes 42 items on 2 subscales: Externalizing Problems and Internalizing Problems.
Total standard scores (M=100, SD=15) will be calculated, with a higher score indicating a higher level of problem behaviors.
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Change from Month 0 (Time 1) to Month 4 (Time 2)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preschoolers' problem behaviors
Time Frame: Change from Month 4 (Time 2) to Month 16 (Time 3)
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Problem behaviors will be assessed by the Preschool and Kindergarten Behavior Scales-Second Edition (PKBS-2).
The Problem Behavior scale includes 42 items on 2 subscales: Externalizing Problems and Internalizing Problems.
Total standard scores (M=100, SD=15) will be calculated, with a higher score indicating a higher level of problem behaviors.
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Change from Month 4 (Time 2) to Month 16 (Time 3)
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Preschoolers' social skills
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Social skills will be assessed by the Preschool and Kindergarten Behavior Scales-Second Edition (PKBS-2).
The Social Skills scale includes 34 items on 3 subscales: Social Cooperation, Social Interaction, and Social Independence.
Total standard scores (M=100, SD=15) will be calculated, with a higher score indicating a higher level of social skills.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Preschoolers' sadness
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Sadness will be assessed by the the 7-item National Institutes of Health (NIH) Toolbox Sadness Parent Report Fixed Form.
Response choices for the 3-Likert scale include: never or not true, sometimes or somewhat true, and often or very true.
A total raw score was calculated and then transformed to the uncorrected T-scores (M=50, SD=10).
A higher T-score indicates a higher level of sadness reported by parents/caregivers.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Preschoolers' fear
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Fear will assessed by the 6-item, 3-Likert (never or not true, sometimes or somewhat true, often or very true) NIH Toolbox Fear-Over Anxious Parent Report Fixed Form.
A total raw score was calculated and then transformed to the uncorrected T-scores (M=50, SD=10).
A high T-score indicates a higher level of fear.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Preschoolers' anger
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Anger will be assessed using the 9-item, 3-Likert (never or not true, sometimes or somewhat true, often or very true) NIH Toolbox Anger Parent Report Fixed Form.
A total raw score was calculated and transformed to the uncorrected T-scores (M=50, SD=10).
A higher T-score indicates a higher level of child anger.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Preschoolers' positive affect
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Positive affect will be assessed by the 9-item NIH Toolbox Positive Affect Parent Report Fixed Form.
Each question has five response choices: not at all, a little bit, somewhat, quite a bit, and very much.
A total raw score was calculated and then transformed to the uncorrected T-scores (M=50, SD=10).
A higher T-score indicates a higher level of positive affect.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Dyads' BMI
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Height will be measured to the nearest 0.1cm using the Shorr board, and weight will be measured to the nearest 0.1kg using the Seca 874 scale or the the portable InBody 270 body composition analyzer.
The online SAS program for Centers for Disease Control and Prevention Growth Charts was applied to calculate preschoolers' BMI for age and sex.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Dyads' percent body fat
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Percent body fat will be measured to the nearest 0.1% using the portable InBody 270 body composition analyzer (FDA cleared medical device).
When measuring % body fat, each participant's study ID, biological sex, age, and height will be entered into the scale.
After the setup, each participant will be instructed to step on the scale surface and align feet with the food electrodes.
When prompted, each participant will grab the hand electrodes by placing their thumbs on the thumb electrodes and wrapping their fingers around the bottom electrodes.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Preschoolers' chronic stress
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Preschoolers' chronic stress will be assessed by hair cortisol concentration level.
A proximal 3-cm segment hair sample, weighing approximately 20 mg, will be cut from 2-3 locations at the posterior vertex of each preschooler's head with a stainless-steel styling shear.
Hair samples (labeled at the root ends furthest away from the head) will be stored in an aluminum foil pouch at room temperature.
The hair samples will be analyzed by the Child Study Center lab at the Yale University.
Cortisol in pg/mg will be extracted from the powdered hair by incubation with methanol for 18-24 hours.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Dyads' physical activity
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Actigraph (wGT3X-BT; 7-day period) worn on hip by both preschoolers and caregivers will be used to measure physical activity.
Before distributing the ActiGraph to dyads for wearing, investigators will use the ActiLife software to initialize each ActiGraph and set to begin data collection at 5 AM on the day after dyads receive the ActiGraph from data collectors.
When distributing the ActiGraph to dyads, the "superhero with a magic belt" story will be shared with preschoolers to encourage them to wear the ActiGraph for 7 consecutive days, and written wear instructions will be provided to caregivers: right hip (attached to belt) from time getting out of bed in AM to going to sleep at night for 7 consecutive days (not worn bathing/swimming).
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Dyads' fruit/vegetable intake
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Fruit/vegetable intake will be assessed by the skin carotenoid levels via Veggie Meter® as well as a 2-question survey.
Each participant's non-dominant index finger will be used, and the average of three scans with a range of 0-850 will be recorded as the final score.
A high Veggie Meter score indicates a higher level of fruit/vegetable intake.
For the 2-question survey, a sum score with a range of 0-10 will be calculated, with a higher score indicating a higher level of fruit/vegetable intake.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregivers' blood pressure
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Systolic and diastolic blood pressure will be assessed by the SunTech CT40 device.
Investigators will follow the procedures in the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: 1) Caffeine, exercise, and smoking will be avoided for at least 30 minutes before measurement; 2) The caregiver will be seated quietly for at least 5 minutes in a chair, with feet on the floor and arms supported at heart level; 3) An appropriate sized cuff (cuff bladder encircling at least 80% of the arm) will be used on the left arm unless having a surgery or injury; 4) Two measurements will be taken at 1 minute interval and averaged for recording; and 5) The caregiver will receive their blood pressure reading in writing as well as the American Heart Association Blood Pressure Fact Sheet demonstrating the blood pressure categories, strategies for controlling blood pressure, and blood pressure resources.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregivers' anxiety
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Anxiety will be measured by the 8-item, 5-Likert Neuro-QoL Anxiety Short Form.
The scale has five response choices (never, almost never, sometimes, fairly often, very often).
A calculated total raw scale score will be transformed to a T-score (mean=50, SD=10).
Higher T-scores indicate greater anxiety levels.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Preschoolers' emotional eating
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Emotional eating among preschoolers will be measured by the 35-item Child Eating Behaviour Questionnaire.
The Child Eating Behaviour Questionnaire has 8 subscales including food responsiveness, emotional over-eating, enjoyment of food, desire to drink, satiety responsiveness, slowness in eating, emotional under-eating, and food fussiness.
Mean scores (range: 1-5) will be calculated for each subscale, and a higher mean score indicates a higher level of that eating behavior.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregiver-preschooler relationship
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregiver-preschooler relationship will be measured by the 15-item Child-Parent Relationship Scale - Short Form (CPRS-SF), which is a 5-point Likert scale with 2 subscales: conflict and closeness.
Sum scores (range for conflict subscale is 8-40, range for closeness subscale is 8-35) will be calculated, with a higher sum score indicating a higher level of relationship.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregiver mindfulness
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregiver mindfulness will be assessed by the 15-item Mindful Attention Awareness Scale, which is a 6-point Likert scale to assess trait mindfulness.
A mean score (min-max: 1-6) will be calculated, with a higher mean score indicating a higher level of mindfulness.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregiver coping
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Parental coping strategies (problem-focused, emotion-focused, and avoidant coping) will be measured by the 28-item Coping Orientation to Problems Experienced Inventory (Brief-COPE).
It is a 4-point Likert scale.
Mean scores (min-max: 1-4) will be calculated for each coping category, with a higher mean score indicating a higher level of coping.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Household food insecurity
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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The U.S. Household Food Security Survey Module will be used to assess household, parent, and preschooler food insecurity status.
Raw sum score will be calculated for each outcome (household food insecurity raw score range is 0-18, raw score range for adult food insecurity is 0-10, raw score range for child food insecurity is 0-8) and then divided into food insecure and food secure categories.
A higher raw score indicates a higher level of food insecurity.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Home environment
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Home environment will be assessed by the 20-item Family Nutrition and Physical Activity Screening Tool.t has two subscales: eating and physical activity home environment.
A sum score, with a range of 10-80 will be calculated, with a higher sum score indicating a healthier home environment.
I
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregivers' depression
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Depression will be measured by the Neuro-QoL Depression Short Form.
The 8-item Neuro-QoL Depression Short Form has five response choices (never, almost never, sometimes, fairly often, very often).
A calculated total raw score will be transformed to a T-score (mean=50, SD=10).
Higher T-scores indicate greater depression levels.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregivers' anxiety and depression
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregivers' anxiety and depression will be measured by the Patient Health Questionnaire (PHQ)-4.
The PHQ-4 is a four questionnaire answered on a four point Likert-type scale.
It has the two-item measure for depression (PHQ-2) and a two-item measure for anxiety (Generalized Anxiety Disorder, GAD-2).
The total PHQ-4 score (range 0-12) will be calculated, with a higher score indicating a higher level of anxiety and depression.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregivers' emotional eating
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Emotional eating among caregivers will be measured by the 18-item Three-Factor Eating Questionnaire.
The 18-item Three-Factor Eating Questionnaire has three subscales including uncontrolled eating, cognitive restraint, and emotional eating.
Mean scores (range 1-4) will be calculated, with a higher score indicating a higher level of emotional eating.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregivers' stress
Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Caregivers' stress will be assessed by the 10-item Perceived Stress Scale.
It is a 5-point Likert scale, with response choices of never to very often.
A sum score (range: 0-40) will be calculated, with a higher sum score indicating a higher level of perceived stress.
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Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00009256
- 1UG3AT012521-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified electronic data and associated documentations will be archived for future use. Data will only be made available under the terms and conditions consistent with the informed consent and as approved by the university IRB and any laws and regulations.
All personal identifiers (e.g., name, contact data) will be deleted from datasets. Investigators will replace original ID numbers with new, randomized ID numbers to serve linkage with existing data both in terms of the ID number and order within the data.
Key study documents (e.g., protocols, procedures, and instruments) that will enable the use of prepared datasets by outside investigators will be provided. Study documentations will include descriptive information regarding study protocols, data collection instruments, codebooks, algorithms for calculated or derived data elements, descriptions of data derived from objective measurements or procedures, and descriptions of all variable recoding performed.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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