NCT03431051

Brief Summary

The study is designed to determine if instituting a Healthy Beverage Initiative (HBI) at hospitals influences health and wellness of employees over a 12 month period.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
648

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

3.9 years

First QC Date

January 29, 2018

Last Update Submit

August 10, 2022

Conditions

Health and Wellness

Keywords

Healthy Beverage Initiative, Sugar Sweetened Beverages

Outcome Measures

Primary Outcomes (2)

  • Abdominal adiposity

    Study participants at HBI campuses will show improvements (specifically, decreases) in indices of abdominal adiposity measured using waist circumference in centimeters.

    About one year.

  • Abdominal adiposity

    Study participants at HBI campuses will show improvements (specifically, decreases) in indices of abdominal adiposity measured using sagittal abdominal diameter in centimeters.

    About one year.

Secondary Outcomes (2)

  • Body Mass Index (BMI)

    About one year.

  • Sugar Sweetened Beverage Intake

    About one year.

Study Arms (2)

Healthy Beverage Initiative

ACTIVE COMPARATOR

A Healthy Beverage Initiative and health education will be implemented at two hospital campuses.

Other: Healthy Beverage Initiative

Control Arm

NO INTERVENTION

No change in beverages or education at two hospital campuses.

Interventions

Healthy Beverage InitiativeOTHER

A Healthy Beverage Initiative will be instituted at two hospital campuses.

Healthy Beverage Initiative

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The participant speaks and reads English.
  • The participant consumes three or more sugar-sweetened beverages a week.
  • The participant expects to be able to participate for all 3 visits (baseline, 6 months, and 12 months).

You may not qualify if:

  • The participant is planning an extended leave of absence and/or family medical leave of absence over the next 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Study Officials

  • Greg Tranah, PhD

    Sutter Health-California Pacific Medical Center Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Research

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 13, 2018

Study Start

January 18, 2018

Primary Completion

November 30, 2021

Study Completion

December 31, 2022

Last Updated

August 12, 2022

Record last verified: 2022-08

Locations

US(1)