Skip to main content
OpenTrials
Completed

NCT Number: NCT05356338

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

Pilot test the health system-based intervention to improve family beverage choices and promote water consumption, engaging WIC nutritionists to augment the intervention with follow-up and counseling of families at regularly-scheduled WIC appointments in a small randomized trial among 30 WIC-enrolled families.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

About this study

This is a pilot 2-arm randomized trial among 30 WIC enrolled families of children 6 months through 4 years old who currently over-consume sugary drinks. The study team will randomize families to either an intervention group, that will receive a behavioral intervention consisting of two educational videos, a water promotion toolkit, mobile phone app, series of educational phone calls and extra counseling from WIC nutritionists, or to a control group that will not receive this intervention. The study team will compare 6-month change in child and parental beverage consumption between groups. Exploratory analyses will examine child weight (kg) and Body Mass Index (BMI) z-score (BMIz) outcomes, and compare intervention effects across race/ethnic groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child 6 months - 4 years old who receives health care attention at Wake Forest pediatric or family medicine practices
  • Child enrolled in WIC
  • Child consumes 2 or more SSB and/or fruit juice total per day
  • Child with no chronic health condition
  • Child has not seen nutritionist or visited our family-based weight management clinic in the past year
  • Parent/caregiver who has not watch educational video "Get in the Zero Zone"
  • Parent/caregiver has a smartphone and reliable internet
  • Parent/caregiver able to communicate well in English

Exclusion criteria

  • Child doesn't meet age criteria
  • Child consumes less than 2 SSB and/or fruit juice total per day
  • Child with a chronic health condition
  • Child has seen nutritionist or visited our family-based weight management clinic in the past year
  • Parent/caregiver has watched educational video "Get in the Zero Zone"
  • Parent/caregiver has completed interview or usability test
  • Parent/caregiver doesn't have a smartphone or reliable internet
  • Parent/caregiver not able to communicate well in English

Treatment and study plan

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

Behavioral

A 6-month intervention based on the use of 5 components: 2 educational videos, provision of a water-promotion "toolkit," a mobile phone application (app), a series of 14 computerized interactive voice response (IVR) phone calls to parents and 2 counseling sessions by a WIC nutritionist to compare families' SSB's consumption behaviors

Primary outcomes

  1. Change in child sugary drink serving consumption

    Time frame: from baseline to month 3

    change in a child's combined consumption of Sugar-Sweetened Beverages (SSB)+Fruit Juice (FJ), measured as total servings per day, at 3 and 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument

  2. Change in child sugary drink serving consumption

    Time frame: from baseline to month 6

    change in a child's combined consumption of Sugar-Sweetened Beverages (SSB)+Fruit Juice (FJ), measured as total servings per day, at 3 and 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument

Secondary outcomes

  1. BevQ 15 - Children Change in Servings of Water Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total servings of water consumed by children

  2. BevQ 15 - Children Change in Servings of SSBs Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total servings of SSBs consumed by children

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

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total servings of 100% fruit juice consumed by children

  4. BevQ 15 - Children Change in total Volume of Water Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total volume of water consumed by children

  5. BevQ 15 - Children Change in total Volume of SSBs Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total volume of SSBs consumed by children

  6. BevQ 15 - Children Change in total Volume of 100% Fruit Juice Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total volume of 100% fruit juice consumed by children

  7. BevQ 15 - Children Change in total calories of beverages consumption

    Time frame: from baseline to month 3, from baseline to month 6

    Changes in calories of beverages consumed by children

  8. BevQ 15 -Parental Change in Servings of Water Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    Changes in total servings of water consumed by parents

  9. BevQ 15 -Parental Change in Servings of SSBs Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    Changes in total servings of SSBs consumed by parents

  10. BevQ 15 -Parental Change in Servings of 100% Fruit Juice Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    Changes in total servings of 100% fruit juice consumed by parents

  11. BevQ 15 -Parental Change in Volume of Water Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total volume of water consumed by parents

  12. BevQ 15 -Parental Change in Volume of SSBs Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total volume of SSBs consumed by parents

  13. BevQ 15 -Parental Change in Volume of 100% fruit juice Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total volume of 100% fruit juice consumed by parents

  14. BevQ 15-Parental Change in Calories of Beverage Consumption

    Time frame: from baseline to month 3, from baseline to month 6

    changes in total beverage calories for parents

  15. Changes in parent knowledge

    Time frame: from baseline, month 6

    Survey knowledge items will be "scored" in terms of correct or not with a range of 0-17 possible points, with higher score demonstrating more knowledge about SSB and FJ.

  16. Changes in Parent Attitudes

    Time frame: from baseline, month 6

    Attitude and belief items will be reported individually, as these are not objectively correct or incorrect and represent a subjective state of the parent's point of view. These will be reported out as frequencies / descriptive statistics, with change in proportion responding a certain way examined over follow-up. Statistician will use Statistical Analysis Software (SAS) for quantifying qualitative data.

  17. Changes in Parent Beliefs

    Time frame: from baseline, month 6

    Belief items will be reported individually, as these are not objectively correct or incorrect and represent a subjective state of the parent's point of view. These will be reported out as frequencies / descriptive statistics, with change in proportion responding a certain way examined over follow-up. Statistician will use Statistical Analysis Software (SAS) for quantifying qualitative data.

  18. Child Weight Change

    Time frame: from baseline to month 3, from baseline to month 6

    change in child weight (kg) using Electronic Health Record (EHR) data

  19. Child Body Mass Index Z-Score (BMIz) Change

    Time frame: from baseline to month 3, from baseline to month 6

    change in child BMIz also using EHR data

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Expanding Reach of a Health System Intervention for Family Beverage Choice by Partnering With a Local WIC Program

Acronym: WHISPER

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 2, 2022
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.