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Behavioral Intervention

Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC for Childhood Obesity (WHISPER Trial)

Q: What type of participants are favored for inclusion in this trial?

<p>This is an <a href="https://www.withpower.com/clinical-trials/obesity">obesity</a>-focused study targeting 60 toddlers aged between 6 Months and 4. Suitable applicants must be cared for at Wake Forest paediatric or family medicine practices, enrolment in the WIC program, consumption of two or more sugary drinks/fruit juice per day, no pre-existing chronic health condition, have not visited a nutritionist in the past year nor watched “Get In The Zero Zone” video; furthermore their parent/caregiver should possess a smartphone with active internet connection plus capable communication skills in English.</p>

N/A

Waitlist Available

Led By Kristina Lewis, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to month 3, from baseline to month 6

Awards & highlights

WHISPER Trial Summary

This trial will test whether a health system-based intervention can improve families' beverage choices and promote water consumption. 30 families will be enrolled and randomly assigned to either the intervention or control group.

Eligible Conditions

Childhood Obesity

WHISPER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to month 3, from baseline to month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to month 3, from baseline to month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to month 3, from baseline to month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in child sugary drink serving consumption

Secondary outcome measures

BevQ 15 - Children Change in Servings of 100% Fruit Juice Consumption

BevQ 15 - Children Change in Servings of SSBs Consumption

BevQ 15 - Children Change in Servings of Water Consumption

+16 more

WHISPER Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Intervention participants will receive a 6-month behavioral intervention with the following components: A water promotion toolkit that includes water bottles, water flavor infusers, stickers to decorate bottles, children's book about water consumption, and instructions for other intervention components (how to view videos, download app, and prepare for calls) Two brief educational videos: a 5-minute video about healthy drink choices for the family and a 3-min video educating residents about local water. Ready, Set Gulp! app for families that will help all family members track their beverage intake, find out how much water and sugar they are consuming, set goals, compete for points, answer quiz questions and create new recipes for flavor infused water. A series of 14 interactive voice response phone calls to parents over 6 months that educate parents on topics relevant to improving family drink choices. Two counseling sessions by a WIC nutritionist at months 2 and 4

Group II: ControlActive Control1 Intervention

The control group participants in this study will not receive any intervention as is the current standard of clinical care for excess sugary drink consumption. They will receive monthly check-in reminders from research staff to promote engagement and retention and will participate in data collection visits at baseline, 3 and 6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC

2022

N/A

~20

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,239 Previous Clinical Trials

1,004,163 Total Patients Enrolled

Kristina Lewis, MDPrincipal InvestigatorWake Forest University Health Sciences

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of participants are favored for inclusion in this trial?

"This is an obesity-focused study targeting 60 toddlers aged between 6 Months and 4. Suitable applicants must be cared for at Wake Forest paediatric or family medicine practices, enrolment in the WIC program, consumption of two or more sugary drinks/fruit juice per day, no pre-existing chronic health condition, have not visited a nutritionist in the past year nor watched “Get In The Zero Zone” video; furthermore their parent/caregiver should possess a smartphone with active internet connection plus capable communication skills in English."

Answered by AI

Are participants currently being sought for this clinical trial?

"Affirmative. Evidenced by clinicaltrials.gov, this medical experiment has opened recruitment and is looking for 60 participants from a single centre. The trial was posted on May 25th 2022 and was last edited on November 29th 2022."

Answered by AI

How many people can participate in this trial at maximum capacity?

"Affirmative. Records on clinicaltrials.gov demonstrate that this medical research, which was initially posted on May 25th 2022, is presently recruiting individuals. Sixty participants need to be recruited from 1 trial site."

Answered by AI

Is enrollment available for senior citizens in this clinical experiment?

"To qualify for this study, participants must be between 6 Months and 4 Years of age. There are 147 clinical trials catered to minors and 28 specifically designed for seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Expanding Health System Intervention Through The Women, Infants and Children (WIC) Program Partnership

2022. "Expanding Health System Intervention Through The Women, Infants and Children (WIC) Program Partnership". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05356338.