NCT02934113

Brief Summary

The purpose of this study is to test a workplace intervention program targeted at low SES workers. Working in partnership with BJC HealthCare, we will test an innovative multi-level intervention that includes an interactive obesity treatment program (iOTA) using SMS text messaging. The iOTA intervention will be embedded in a newly described Healthy Workplace Participatory Program, which incorporates employee participation in decision making to produce changes in the workplace environment that are acceptable, effective, and sustainable. These nested interventions will be tested a large delayed-start group-randomized trial. This study will rigorously test readily scalable interventions that can be translated to other work settings to reduce obesity and diabetes risk among low SES workers, a group at high risk for these disorders. This pragmatic clinical trial will advance the long-term goal of enabling employers and employees to reduce obesity and obesity-associated illnesses including diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,283

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

3.9 years

First QC Date

October 12, 2016

Last Update Submit

April 5, 2021

Conditions

ObesityDiabetes

Keywords

weight losstext messagingworkplaceparticipatory approachhealth care workers

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    24 months

Study Arms (3)

Control

NO INTERVENTION

iOTA and HWPP

EXPERIMENTAL
Behavioral: iOTABehavioral: HWPP

HWPP

EXPERIMENTAL
Behavioral: HWPP

Interventions

iOTABEHAVIORAL

The Individual Obesity Treatment Approach (iOTA) will assess individual behavior risks, collaborative goal-setting with a health coach, and the use of an interactive text system to provide ongoing support and self-monitoring of behavior change goals.

iOTA and HWPP
HWPPBEHAVIORAL

Work groups will participate in the Healthy Workplace Participatory Program (HWPP) to adapt and deploy interventions that change their work environments to support healthy eating and physical activity.

HWPPiOTA and HWPP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants must be a member of a chosen work group
  • Speak English
  • At least 18 years of age
  • Sub-group (iOTA Intervention): BMI \>=30, cell phone with text messaging capability

You may not qualify if:

  • Sub-group (iOTA Intervention): pregnant or nursing, weight-loss surgery in past 12 mths, currently receiving chemotherapy or radiation treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • Stein RI, Strickland JR, Tabak RG, Dale AM, Colditz GA, Evanoff BA. Design of a randomized trial testing a multi-level weight-control intervention to reduce obesity and related health conditions in low-income workers. Contemp Clin Trials. 2019 Apr;79:89-97. doi: 10.1016/j.cct.2019.01.011. Epub 2019 Jan 19.

    PMID: 30664943DERIVED

  • Tabak RG, Strickland JR, Stein RI, Dart H, Colditz GA, Kirk B, Dale AM, Evanoff BA. Development of a scalable weight loss intervention for low-income workers through adaptation of interactive obesity treatment approach (iOTA). BMC Public Health. 2018 Nov 16;18(1):1265. doi: 10.1186/s12889-018-6176-0.

    PMID: 30445939DERIVED

MeSH Terms

Conditions

ObesityDiabetes MellitusWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBody Weight Changes

Study Officials

  • Bradley A Evanoff, MD, MPH

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 14, 2016

Study Start

September 1, 2016

Primary Completion

July 31, 2020

Study Completion

December 31, 2020

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

Investigators will add data to the NIDDK data repository and share it in accordance with the NIDDK data sharing policy upon conclusion of the study.

Locations

US(1)